carbetocin and Postpartum-Hemorrhage

Heat-stable carbetocin (HSC), a long-acting oxytocin analogue that does not require cold-chain transportation and storage, is effective in preventing postpartum haemorrhage (PPH) in vaginal and caesarean deliveries in tertiary-care settings. We aimed to identify literature documenting how it is implemented in resource-limited and lower-level maternity care settings to inform policies and practices that enable its introduction in these contexts. A rapid scoping review was conducted with an 8-week timeframe by two reviewers. MEDLINE, EMBASE, Emcare, the Joanna Briggs Institute Evidence-Based Practice Database, the Maternity and Infant Care Database, and the Cochrane Library were searched for publications in English, French, and Spanish from January 2011 to September 2021. Randomized and non-randomized studies examining the feasibility, acceptability, and health system considerations in low-income and lower-middle-income countries were included. Relevant data were extracted using pretested forms, and results were synthesized descriptively. The search identified 62 citations, of which 12 met the eligibility criteria. The review did not retrieve studies focusing on acceptability and health system considerations to inform HSC implementation in low-resource settings. There were no studies located in rural or lower-level maternity settings. Two economic evaluations concluded that HSC is not feasible in terms of cost-effectiveness in lower-middle-income economies with private sector pricing, and a third one found superior care costs in births with PPH than without. The other nine studies focused on demonstrating HSC effectiveness for PPH prevention in tertiary hospital settings. There is a lack of evidence on the feasibility (beyond cost-effectiveness), acceptability, and health system considerations related to implementing HSC in resource-constrained and lower-level maternity facilities. Further implementation research is needed to help decision-makers and practitioners offer an HSC-inclusive intervention package to prevent excessive bleeding among pregnant women living in settings where oxytocin is not available or of dubious quality.

Topics: Female; Hot Temperature; Humans; Maternal Health Services; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

The efficacy of oxytocin and carbetocin in preventing postpartum hemorrhage (PPH) in women with vaginal delivery has been controversial. This study is aimed at conducting a meta-analysis that compares the efficacy of carbetocin and oxytocin in the prevention of PPH among women with vaginal delivery.. Literature was retrieved from PubMed, Medline, Embase, CENTRAL, and CNKI databases. The randomized controlled trials (RCTs) that compare the efficacy of carbetocin and oxytocin to prevent PPH were searched. Data from the included literatures were extracted by two researchers, including author, title, publication date, study type, study number, the incidence of PPH, number of patients requiring additional uterotonics, and number of patients requiring blood transfusion. Jadad scale was used to evaluate the quality of the included RCTs. The Chi-square test was adopted for the heterogeneity test. A fixed-effect model was used for analysis if heterogeneity did not exist between literatures. If heterogeneity exists between literatures, a random-effect model was used for analysis. The source of heterogeneity was explored by subgroup analysis and sensitivity analysis.. The incidence of PPH in the carbetocin group was lower than that in the oxytocin group (OR = 0.62, 95% CI (0.46, 0.84),. Carbetocin is superior to oxytocin in preventing PPH among women with vaginal delivery and can be widely used in clinical practice.

Topics: Delivery, Obstetric; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Postpartum haemorrhage is a common complication of pregnancy, most commonly due to uterine atony. Uterotonics have a vital role in preventing postpartum haemorrhage but the choice of the most effective agent with the fewest adverse effects is a subject of debate. Carbetocin, a synthetic analogue of oxytocin has been available in the UK since 2007 but is not currently widely used. It has a longer duration of action than oxytocin, which avoids the need for an infusion and as it is heat-stable it can be stored at room temperature. Current UK clinical guidelines, based on the results of older meta-analyses, do not recommend carbetocin as a first-line agent. A

Topics: Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Postpartum Period; Pregnancy

To evaluate the efficacy of carbetocin for the prevention of postpartum hemorrhage (PPH) and related events after vaginal or cesarean delivery.. Medline, Scopus, Embase, and the Cochrane Library were searched in February 2018 using combinations of the relevant MeSH terms, keywords. Randomized studies, comparing carbetocin to any other uterotonic agent, in the management of cesarean and vaginal deliveries, were conducted. Two reviewers independently extracted the data. A random-effects meta-analysis was used for quantitative synthesis. Also, Bayesian random-effect metaregression was used to estimate the posterior probabilities (PP) for benefits of carbetocin use.. Carbetocin is effective in reducing the need for additional uterotonic use and postpartum blood transfusion in women at increased risk of PPH undergoing cesarean delivery. There is still a need for high-quality trials on its effectiveness in preventing PPH in high-risk women.PrecisCarbetocin is effective in reducing the need for additional uterotonic use and postpartum blood transfusion in high-risk women undergoing Cesarean delivery.

Topics: Bayes Theorem; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Postpartum hemorrhage (PPH) increases the risk of maternal death worldwide. Heat-stable carbetocin, a long-acting oxytocin analog, is a newer uterotonic agent. Clinicians do not fully understand its side-effects, particularly the unanticipated side-effects. The aim of this study is to investigate the side-effects of carbetocin to PPH. The Cochrane Library, Web of Science, PubMed, Elsevier ScienceDirect, Embase, and ClinicalTrials.gov were searched from the inception to September 2020. Randomized controlled trials (RCTs) that considered pregnant women who received carbetocin before delivery and provided at least one adverse event were included. Statistical analysis included random or fixed-effect meta-analyses using relative risk. Stratified analyses and sensitivity analyses were also performed. Begger's and Egger's test and funnel plots were used to assess the publication bias. Seventeen RCTs involving 32,702 women were included, and all these studies ranked as medium- to high-quality. Twenty-four side-effects were reported. The use of carbetocin had a lower risk of vomiting in intravenously (0.53, 0.30 to 0.93) and cesarean birth (0.51, 0.32 to 0.81) women, and had a slightly higher risk of diarrhea (8.00, 1.02 to 62.79) compared with oxytocin intervention. No significant difference was found among other side-effects. Evidence from our systematic review and meta-analysis of 17 RCTs suggested that the risk of vomiting decreased with carbetocin use in the prevention of PPH after delivery.

Topics: Administration, Intravenous; Cesarean Section; Diarrhea; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Vomiting

Carbetocin has been shown to reduce the requirement for additional uterotonics in women exclusively undergoing elective Cesarean delivery (CD). The aim of this review was to determine whether this effect could also be demonstrated in the setting of non-elective CD.. Medline, Embase, CINAHL, Web of Science and Cochrane databases were searched for randomized-controlled trials (RCTs) in any language comparing carbetocin to oxytocin. Studies with data on women undergoing non-elective CD, where carbetocin was compared with oxytocin, were included. The primary outcome was the need for additional uterotonics. Secondary outcomes included incidence of blood transfusion, estimated blood loss (mL), incidence of postpartum hemorrhage (PPH; > 1000 mL) and mean hemoglobin drop (g·dL. Carbetocin reduces the need for additional uterotonics in non-elective CD compared with oxytocin. TSA confirmed that this analysis was appropriately powered to detect the pooled estimated effect. Further trials utilizing consistent core outcomes are needed to determine an effect on PPH.. PROSPERO CRD42019147256, registered 13 September 2019.. RéSUMé: OBJECTIF: Il a été démontré que la carbétocine réduisait les besoins en utérotoniques supplémentaires exclusivement chez les femmes subissant un accouchement par césarienne planifié. L’objectif de ce compte rendu était de déterminer si cela pouvait également être démontré dans le cas d’un accouchement par césarienne non planifié. MéTHODE: Les bases de données Medline, Embase, CINAHL, Web of Science et Cochrane ont été passées en revue pour en extraire les études randomisées contrôlées (ERC), toutes langues confondues, comparant la carbétocine à l’ocytocine. Les études comportant des données concernant des femmes subissant un accouchement par césarienne non planifié et comparant la carbétocine à l’ocytocine ont été incluses. Le critère d’évaluation principal était le besoin d’utérotoniques supplémentaires. Les critères secondaires comprenaient l’incidence de transfusion sanguine, la perte de sang estimée (mL), l’incidence d’hémorragie postpartum (HPP; > 1000 mL) et la baisse moyenne du taux d’hémoglobine (g·dL

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

To evaluate the efficacy and safety of carbetocin for prevention of postpartum hemorrhage in women undergoing vaginal delivery compared with oxytocin.. We conducted a systemic literature search in PubMed, the Cochrane Library, and Embase without language restrictions from inception of each of database to November 18th, 2018. Randomized controlled trials with outcome measure of blood loss ≥500 ml were eligible if they compared carbetocin with oxytocin to prevent postpartum hemorrhage during the third stage of labor in women undergoing vaginal delivery.. This meta-analysis of 5 randomized controlled trials (30,314 women) indicated that there was no significant difference between carbetocin and oxytocin in blood loss ≥500 ml in women undergoing vaginal delivery (relative risks (RRs), 0.52; 95% confidence intervals (CIs), 0.24 to 1.15; P = .11; I = 69%). Sensitivity analyses showed the same results. No significant differences were found in blood loss ≥1000 ml, use of additional uterotonic agents, blood transfusion, uterine massage, flushing, vomiting, abdominal pain, nausea, dizziness, headache, palpitation, itching, and shivering.. This meta-analysis showed that carbetocin was as effective and safe as oxytocin for prevention of postpartum hemorrhage in women undergoing vaginal delivery, and the choice of carbetocin for routine prophylaxis will depend on cost-effectiveness.

Topics: Delivery, Obstetric; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Treatment Outcome

Several uterotonic options exist for prevention of postpartum hemorrhage (PPH); hence, cost-effectiveness is an important decision-making criterion affecting uterotonic choice.. To conduct a systematic review of cost-effectiveness of uterotonics for PPH prevention to support a WHO guideline update.. We searched major databases from 1980 to June 2018 and the National Health Services Economic Evaluation (NHS EED) database from inception (1995) to March 2015 for eligible studies.. We included comparative economic evaluations, cost-utility analyses, and resource-utilization studies.. Two reviewers independently assessed studies and extracted data organized by birth mode and setting.. We included 15 studies across all income categories that compared misoprostol versus no uterotonic (five studies) or versus oxytocin (one study), carbetocin versus oxytocin (eight studies), and one study comparing numerous uterotonics. In specific low-resource contexts, we found reasonably good evidence that misoprostol was cost-effective compared with no uterotonic. In the context of cesarean delivery, carbetocin was more cost favorable than oxytocin but certainty of this evidence was low.. Evidence on the cost-effectiveness of various uterotonic agents was not generalizable. As the number of competing uterotonics increases, rigorous economic evaluations including contextual factors are needed.

Topics: Case-Control Studies; Cost-Benefit Analysis; Female; Humans; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Every six minutes, a mother dies from post-partum haemorrhage (PPH) in low- and middle-income countries, often in the prime of her life and often leaving behind a young family. To prevent PPH, the routine administration of a uterus-contracting ('uterotonic') agent is a standard practice across the world. Oxytocin is the standard uterotonic agent recommended for this purpose, and is recommended for all women giving birth. Oxytocin is problematic as it requires cold storage and transport, and in low-resource settings, the cold chain is not commonly available. Hence, using heat-stable carbetocin in these settings can be advantageous. Heat-stable carbetocin is a promising alternative to oxytocin. Because of its heat stability, it can overcome the persistent problems with oxytocin quality as it does not require cold chain for storage and transport. Considering the totality of the evidence, it appears to have some additional desirable effects compared with oxytocin and a very favourable side effect profile similar to oxytocin. However, because carbetocin costs 20 times more than oxytocin and is not widely available yet, oxytocin remains the mainstay for prevention of PPH. However, this may change as WHO has signed a memorandum of understanding with the manufacturer to provide carbetocin for the public sector of LMIC at a similar price level to that of oxytocin. Currently, carbetocin is being registered in 90 low- and middle-income countries to be made available and improve access to this life-saving uterotonic agent.

Topics: Female; Humans; Oxytocics; Oxytocin; Parturition; Postpartum Hemorrhage; Pregnancy

Carbetocin has been found to be superior to oxytocin in terms of need for additional uterotonics and prevention of postpartum haemorrhage at caesarean delivery. However, this is based on combined data from labouring and non-labouring parturients and it remains unclear how effective carbetocin is in the purely elective setting. The aim of this review was to compare carbetocin to oxytocin in elective caesarean delivery.. Medline, Embase, CINAHL, Web of Science, and the Cochrane databases were searched for randomised controlled trials in any language. The primary outcome was need for additional uterotonics. Secondary outcomes were mean blood loss, need for blood transfusion and incidence of postpartum haemorrhage >1000 mL.. Nine studies with a total of 1962 patients were included. Trial sequential analysis confirmed that the information size (n=1692) had surpassed that required (n=1166) in order to demonstrate a statistically significant reduction in the use of additional uterotonics. Need for additional uterotonics was reduced by 53% with carbetocin compared to oxytocin (OR 0.47, 95% CI 0.34 to 0.64; P <0.001, I. Carbetocin is associated with a reduced need for additional uterotonics when compared with oxytocin at elective caesarean delivery. Standardisation of bleeding-related outcomes in studies is necessary to facilitate synthesis of data in future analyses.

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic drugs can prevent PPH, and are routinely recommended. There are several uterotonic drugs for preventing PPH but it is still debatable which drug is best.. To identify the most effective uterotonic drug(s) to prevent PPH, and generate a ranking according to their effectiveness and side-effect profile.. We searched Cochrane Pregnancy and Childbirth's Trials Register (1 June 2015), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for unpublished trial reports (30 June 2015) and reference lists of retrieved studies.. All randomised controlled comparisons or cluster trials of effectiveness or side-effects of uterotonic drugs for preventing PPH.Quasi-randomised trials and cross-over trials are not eligible for inclusion in this review.. At least three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for preventing PPH ≥ 500 mL and PPH ≥ 1000 mL as primary outcomes. We performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available drugs. We stratified our primary outcomes according to mode of birth, prior risk of PPH, healthcare setting, dosage, regimen and route of drug administration, to detect subgroup effects.The absolute risks in the oxytocin are based on meta-analyses of proportions from the studies included in this review and the risks in the intervention groups were based on the assumed risk in the oxytocin group and the relative effects of the interventions.. This network meta-analysis included 140 randomised trials with data from 88,947 women. There are two large ongoing studies. The trials were mostly carried out in hospital settings and recruited women who were predominantly more than 37 weeks of gestation having a vaginal birth. The majority of trials were assessed to have uncertain risk of bias due to poor reporting of study design. This primarily impacted on our confidence in comparisons involving carbetocin trials more than other uterotonics.The three most effective drugs for prevention of PPH ≥ 500 mL were ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination. These three options were more effective at preventing PPH ≥ 500 mL compared with oxytocin, the drug currently recommended by the WHO (ergometrine plus oxytocin risk ratio (RR) 0.69 (95% confidence interval (CI) 0.57 to 0.83), moderate-quality evidence; carbetocin RR 0.72 (95% CI 0.52 to 1.00), very low-quality evidence; misoprostol plus oxytocin RR 0.73 (95% CI 0.60 to 0.90), moderate-quality evidence). Based on these results, about 10.5% women given oxytocin would experience a PPH of ≥ 500 mL compared with 7.2% given ergometrine plus oxytocin combination, 7.6% given carbetocin, and 7.7% given misoprostol plus oxytocin. Oxytocin was ranked fourth with close to 0% cumulative probability of being ranked in the top three for PPH ≥ 500 mL.The outcomes and rankings for the outcome of PPH ≥ 1000 mL were similar to those of PPH ≥ 500 mL. with the evidence for ergometrine plus oxytocin combination being more effective than oxytocin (RR 0.77 (95% CI 0.61 to 0.95), high-quality evidence) being more certain than that for carbetocin (RR 0.70 (95% CI 0.38 to 1.28), low-quality evidence), or misoprostol plus oxytocin combination (RR 0.90 (95% CI 0.72 to 1.14), moderate-quality evidence)There were no meaningful differences between all drugs for maternal deaths or severe morbidity as these outcomes were so rare in the included randomised trials.Two combination regimens had the poorest rankings for side-effects. Specifically, the ergometrine plus oxytocin combination had the higher risk for vomiting (RR 3.10 (95% CI 2.11 to 4.56), high-quality evidence; 1.9% versus 0.6%) and hypertension [RR 1.77 (95% CI 0.55 to 5.66), low-quality evidence; 1.2% versus 0.7%), while the misoprostol plus oxytocin combination had the higher risk for fever (RR 3.18 (95% CI 2.22 to 4.55), moderate-quality evidence; 11.4% versus 3.6%) when compare. Ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination were more effective for preventing PPH ≥ 500 mL than the current standard oxytocin. Ergometrine plus oxytocin combination was more effective for preventing PPH ≥ 1000 mL than oxytocin. Misoprostol plus oxytocin combination evidence is less consistent and may relate to different routes and doses of misoprostol used in the studies. Carbetocin had the most favourable side-effect profile amongst the top three options; however, most carbetocin trials were small and at high risk of bias.Amongst the 11 ongoing studies listed in this review there are two key studies that will inform a future update of this review. The first is a WHO-led multi-centre study comparing the effectiveness of a room temperature stable carbetocin versus oxytocin (administered intramuscularly) for preventing PPH in women having a vaginal birth. The trial includes around 30,000 women from 10 countries. The other is a UK-based trial recruiting more than 6000 women to a three-arm trial comparing carbetocin, oxytocin and ergometrine plus oxytocin combination. Both trials are expected to report in 2018.Consultation with our consumer group demonstrated the need for more research into PPH outcomes identified as priorities for women and their families, such as women's views regarding the drugs used, clinical signs of excessive blood loss, neonatal unit admissions and breastfeeding at discharge. To date, trials have rarely investigated these outcomes. Consumers also considered the side-effects of uterotonic drugs to be important but these were often not reported. A forthcoming set of core outcomes relating to PPH will identify outcomes to prioritise in trial reporting and will inform futures updates of this review. We urge all trialists to consider measuring these outcomes for each drug in all future randomised trials. Lastly, future evidence synthesis research could compare the effects of different dosages and routes of administration for the most effective drugs.

Topics: Drug Therapy, Combination; Ergonovine; Female; Fever; Humans; Hypertension; Misoprostol; Network Meta-Analysis; Oxytocics; Oxytocin; Postpartum Hemorrhage; Vomiting

Postpartum hemorrhage remains the leading cause of maternal mortality in developing countries and a significant proportion of these cases are attributable to uterine atony. In contrast to the advances made in the treatment of postpartum hemorrhage, there has been few novel prophylactic agents. This study was undertaken to analyze the effectiveness of carbetocin compared to oxytocin for the prevention of postpartum hemorrhage, in the context of cesarean deliveries.. Major electronic databases were searched for randomized-controlled trials comparing carbetocin with oxytocin. Only trials involving cesarean deliveries were included. Non-randomized trials, non-cesarean deliveries, studies which did not directly compare carbetocin to oxytocin and studies which did not analyze the intended outcomes were excluded. Outcomes analysed were postpartum hemorrhage, additional use of uterotonic and transfusion requirement.. Seven studies involving 2012 patients were included in the meta-analysis. There was a significant reduction in the rates of postpartum hemorrhage (RR 0.79; 95% CI 0.66 to 0.94; p = 0.009), use of additional uterotonics (RR 0.57; 95% CI 0.49 to 0.65; p < 0.001) and transfusion (RR 0.31; 95% CI 0.15 to 0.64; p = 0.002) when carbetocin rather than oxytocin was used. There was significant heterogeneity across studies however, for the outcome of additional uterotonic usage.. Carbetocin is effective in reducing the use of additional uterotonics, reduction in postpartum hemorrhage and transfusion when used during cesarean deliveries. However, despite the potential benefits illustrated in this meta-analysis, the disparity between the cost of carbetocin and oxytocin suggests that locoregional cost-effectiveness analysis should be performed before any decision is made to adopt it for routine prophylaxis.

Topics: Blood Transfusion; Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and is a significant contributor to severe maternal morbidity and long-term disability. Carbetocin may be an underused uterotonic for prevention of PPH. A number of studies are being conducted that may challenge the place of oxytocin as the first choice of uterotonics for prevention of PPH. This paper describes the current research into carbetocin and ranking of effectiveness of uterotonics that may provide important new information to assist healthcare decision makers to ensure that women receive an effective uterotonic for prevention of PPH.. We searched the WHO International Clinical Trials Registry Platform for current studies on effectiveness of carbetocin for prevention of PPH following vaginal delivery with sample sizes large enough to provide quality evidence to support potential changes to international guidelines. We also searched the Cochrane Library for current systematic reviews including carbetocin used in prevention of PPH.. Susceptibility to degradation from exposure to heat is one of the key causes of reduced effectiveness of oxytocin in preventing PPH from uterine atony. Although heat stable and effective in preventing PPH, misoprostol is also subject to degradation due to exposure to moisture and produces some side-effects. Other uterotonics (including ergometrine and combinations of oxytocin, ergometrine and misoprostol) are also available and used with varying safety and effectiveness profiles and quality issues. Efforts to reduce maternal mortality from PPH include research studies seeking to identify safe, stable, effective uterotonics. Heat stable carbetocin is the subject of two major clinical studies into its effectiveness in preventing PPH following vaginal deliveries, information that could expand its application for prevention of PPH.. Heat stable carbetocin is being investigated as a potential alternative to oxytocin. This paper describes two current clinical trials on carbetocin and a network meta-analysis ranking of all uterotonic agents, including carbetocin, which combined may provide evidence supporting expansion of the use of the heat stable formulation of carbetocin in PPH prevention.

Topics: Delayed-Action Preparations; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome

Postpartum hemorrhage (PPH) and the amount of blood loss are directly related to management of the third stage of labor. No previous report has compared the effects of carbetocin to those of misoprostol. The aim of this systematic review was to compare the effects of carbetocin to those of misoprostol for management of the third stage of labor and for the prevention of PPH.. We searched the Cochrane Library (Central), Web of Science, Scopus, Science Direct, Ovid, clinicaltrial.gov , and PubMed databases on December 28, 2017. Data extraction and risk of bias assessment were performed by 2 of the authors independently. Individual and pooled incidences were calculated for the included studies, with 95% confidence intervals (CIs). We used a fixed model for forest plots without heterogeneity and a random effect model for those with heterogeneity.. Our search identified 117 studies; however, 29 studies were duplicate. Of the 88 non-duplicate studies, 5 met the inclusion criteria. Of these five studies, two are currently underway. Hence, three studies were finally included in our meta-analysis. The pooled estimate of the impact of carbetocin on PPH (500-1000 ml) was (OR 0.27, 95% CI 0.14-0.50). Carbetocin significantly reduced the need for additional uterotonics (RR 0.28, 95% CI 0.15 to 0.49). Reduction in the hemoglobin level and blood loss during the third stage of labor was significantly lower in women who received carbetocin than in those who received misoprostol. The length of the third stage of labor was significantly lower in women who received carbetocin than in those who received misoprostol. The incidence of side effects, such as heat sensation, metallic taste, fever, and shivering, were significantly lower in women who received carbetocin than in those who received misoprostol.. Although this review showed that carbetocin is effective for decreasing PPH, blood loss, the length of the third stage of labor, and the need for additional uterotonics, this conclusion should be considered with caution. Because assessment of PPH is a subjective issue and it is uncertain whether outcomes were assessed blindly in respect to treatment. We recommend future research to verify our findings. Also clinicians may like to consider use of carbetocin for women with low risk for PPH.

Topics: Blood Volume; Female; Hemoglobins; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Time Factors

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic agents can prevent PPH, and are routinely recommended. The current World Health Organization (WHO) recommendation for preventing PPH is 10 IU (international units) of intramuscular or intravenous oxytocin. There are several uterotonic agents for preventing PPH but there is still uncertainty about which agent is most effective with the least side effects. This is an update of a Cochrane Review which was first published in April 2018 and was updated to incorporate results from a recent large WHO trial.. To identify the most effective uterotonic agent(s) to prevent PPH with the least side effects, and generate a ranking according to their effectiveness and side-effect profile.. We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (24 May 2018), and reference lists of retrieved studies.. All randomised controlled trials or cluster-randomised trials comparing the effectiveness and side effects of uterotonic agents with other uterotonic agents, placebo or no treatment for preventing PPH were eligible for inclusion. Quasi-randomised trials were excluded. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved.. At least three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for preventing PPH ≥ 500 mL and PPH ≥ 1000 mL as primary outcomes. Secondary outcomes included blood loss and related outcomes, morbidity outcomes, maternal well-being and satisfaction and side effects. Primary outcomes were also reported for pre-specified subgroups, stratifying by mode of birth, prior risk of PPH, healthcare setting, dosage, regimen and route of administration. We performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available agents.. The network meta-analysis included 196 trials (135,559 women) involving seven uterotonic agents and placebo or no treatment, conducted across 53 countries (including high-, middle- and low-income countries). Most trials were performed in a hospital setting (187/196, 95.4%) with women undergoing a vaginal birth (71.5%, 140/196).Relative effects from the network meta-analysis suggested that all agents were effective for preventing PPH ≥ 500 mL when compared with placebo or no treatment. The three highest ranked uterotonic agents for prevention of PPH ≥ 500 mL were ergometrine plus oxytocin combination, misoprostol plus oxytocin combination and carbetocin. There is evidence that ergometrine plus oxytocin (RR 0.70, 95% CI 0.59 to 0.84, moderate certainty), carbetocin (RR 0.72, 95% CI 0.56 to 0.93, moderate certainty) and misoprostol plus oxytocin (RR 0.70, 95% CI 0.58 to 0.86, low certainty) may reduce PPH ≥ 500 mL compared with oxytocin. Low-certainty evidence suggests that misoprostol, injectable prostaglandins, and ergometrine may make little or no difference to this outcome compared with oxytocin.All agents except ergometrine and injectable prostaglandins were effective for preventing PPH ≥ 1000 mL when compared with placebo or no treatment. High-certainty evidence suggests that ergometrine plus oxytocin (RR 0.83, 95% CI 0.66 to 1.03) and misoprostol plus oxytocin (RR 0.88, 95% CI 0.70 to 1.11) make little or no difference in the outcome of PPH ≥ 1000 mL compared with oxytocin. Low-certainty evidence suggests that ergometrine may make little or no difference to this outcome compared with oxytocin meanwhile the evidence on carbetocin was of very low certainty. High-certainty evidence suggests that misoprostol is less effective in preventing PPH ≥ 1000 mL when compared with oxytocin (RR 1.19, 95% CI 1.01 to 1.42). Despite the comparable relative treatment effects between all uterotonics (except misoprostol) and oxytocin, ergometrine plus oxytocin, misoprostol plus oxytocin combinations and carbetocin were the highest ranked agents for PPH ≥ 1000 mL.Misoprostol plus oxytocin reduces the use of additional uterotonics (RR 0.56, 95% CI 0.42 to 0.73, high certainty) and probably also reduces the risk of blood transfusion (RR 0.51, 95% CI 0.37 to 0.70, moderate certainty) when compared with oxytocin. Carbetocin, injectable prostaglandins and ergometrine plus oxytocin may also reduce the use of additional uterotonics but the certainty of the evidence is low. No me. All agents were generally effective for preventing PPH when compared with placebo or no treatment. Ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination may have some additional desirable effects compared with the current standard oxytocin. The two combination regimens, however, are associated with significant side effects. Carbetocin may be more effective than oxytocin for some outcomes without an increase in side effects.

Topics: Drug Therapy, Combination; Ergonovine; Female; Fever; Humans; Hypertension; Misoprostol; Network Meta-Analysis; Oxytocics; Oxytocin; Postpartum Hemorrhage; Prostaglandins; Randomized Controlled Trials as Topic; Vomiting

To compare the efficacy and safety profile of carbetocin with other uterotonic agents in preventing postpartum hemorrhage.. PubMed, Web of Science, Scopus and EBSCOhost were searched for relevant randomized controlled trials published until September 2013.. Carbetocin was associated with a significantly reduced need for additional uterotonic agents (RR = 0.68, 95% CI: 0.55-0.84, I(2 )= 4%) compared with oxytocin in women following cesarean delivery. However, with respect to postpartum hemorrhage, severe postpartum hemorrhage, mean estimated blood loss and adverse effects, our analysis failed to detect a significant difference. Studies comparing carbetocin with syntometrine in women undergoing vaginal delivery demonstrated no statistical difference in terms of risk of postpartum hemorrhage, severe postpartum hemorrhage or the need for additional uterotonic agents, but the risk of adverse effect was significantly lower in the carbetocin group.. Carbetocin has been associated with a similar low incidence of adverse effects to oxytocin and at least as effective as syntometrine and may become an alternative uterotonic agent for the prevention of postpartum hemorrhage. Further studies should be conducted to determine the safety and efficacy profile of carbetocin in women with cardiac disorders and to analyze the cost-effectiveness and minimum effective dose of carbetocin.

Topics: Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Caesarean section rates are increasing across the world. Postpartum haemorrhage is a major cause of morbidity and mortality; major haemorrhage is more common after caesarean delivery. There is a wide range of practice in the prevention and treatment of postpartum haemorrhage at caesarean section. The aim of this review is to summarize current opinion in the management of postpartum haemorrhage at caesarean section.. Recent large randomized controlled trials have shown a possible effect from the routine use of tranexamic acid and ergometrine. Small randomized controlled trials have shown a possible benefit from using carbetocin.. The impact of postpartum haemorrhage can be reduced by antenatal correction of anaemia. Intraoperative medical management consists of oxytocinon, additional oxytocics +/- tranexamic acid, with at present limited evidence as to the order in which these should be considered. Trials of routine use of cell salvage and tranexamic acid are currently underway.

Topics: Cesarean Section; Ergonovine; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Risk Assessment; Treatment Outcome

Carbetocin is a new synthetic analogue of oxytocin. It has a longer half life than oxytocin. This review examines the current evidence for the use of carbetocin as an alternative to oxytocin, as a first-line agent in the pharmacological management of the third stage of labour.

Topics: Adult; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage

Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH.. To determine if the use of oxytocin agonist is as effective as conventional uterotonic agents for the prevention of PPH, and assess the best routes of administration and optimal doses of oxytocin agonist.. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1 of 4), MEDLINE (1966 to 1 March 2011) and EMBASE (1974 to 1 March 2011). We checked references of articles and communicated with authors and pharmaceutical industry contacts.. Randomised controlled trials which compared oxytocin agonist (carbetocin) with other uterotonic agents or with placebo or no treatment for the prevention of PPH.. Two review authors independently assessed trials for inclusion, assessed risk of bias and extracted data.. We included 11 studies (2635 women) in the review. Six trials compared carbetocin with oxytocin; four of these were conducted for women undergoing caesarean deliveries, one was for women following vaginal deliveries and one did not state the mode of delivery clearly. The carbetocin was administered as 100 µg intravenous dosage across the trials, while oxytocin was administered intravenously but at varied dosages. Four trials compared intramuscular carbetocin and intramuscular syntometrine for women undergoing vaginal deliveries. Three of the trials were on women with no risk factor for PPH, while one trial was on women with risk factors for PPH. One trial compared the use of intravenous carbetocin with placebo. Use of carbetocin resulted in a statistically significant reduction in the need for therapeutic uterotonics (risk ratio (RR) 0.62; 95% confidence interval (CI) 0.44 to 0.88; four trials, 1173 women) compared to oxytocin for those who underwent caesarean section, but not for vaginal delivery. Compared to oxytocin, carbetocin was associated with a reduced need for uterine massage following both caesarean delivery (RR 0.54; 95% CI 0.37 to 0.79; two trials, 739 women) and vaginal delivery (RR 0.70; 95% CI 0.51 to 0.94; one trial, 160 women). Pooled data also showed that carbetocin resulted in a lower risk of PPH compared to oxytocin in women who underwent caesarean delivery (RR 0.55; 95% CI 0.31 to 0.95; three trials, 820 women). This is, however, limited by the number of studies and risk of bias in the studies. Comparison between carbetocin and syntometrine showed a lower mean blood loss in women who received carbetocin compared to syntometrine (mean difference (MD) -48.84 ml; 95% CI -94.82 to -2.85; four trials, 1030 women). There was no statistically significant difference in terms of the need for therapeutic uterotonic agents, but the risk of adverse effects such as nausea and vomiting were significantly lower in the carbetocin group: nausea (RR 0.24; 95% CI 0.15 to 0.40; four trials, 1030 women); vomiting (RR 0.21; 95% CI 0.11 to 0.39; four trials, 1030 women). The incidence of postpartum hypertension was also significantly lower in women who received carbetocin compared to those who received syntometrine. Cost-effectiveness of carbetocin was investigated by one study published as an abstract, with limited data.. There is evidence to suggest that 100 µg of intravenous carbetocin is more effective than oxytocin for preventing PPH in women undergoing caesarean deliveries, but more studies are needed to validate this finding. Carbetocin is associated with less blood loss compared to syntometrine in the prevention of PPH for women who have vaginal deliveries and is associated with significantly fewer adverse effects. Further research is needed to analyse the cost-effectiveness of carbetocin as a uterotonic agent.

Topics: Cesarean Section; Delayed-Action Preparations; Ergonovine; Female; Humans; Injections, Intramuscular; Injections, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH.. To determine if the use of oxytocin agonist is as effective as conventional uterotonic agents for the prevention of PPH, and assess the best routes of administration and optimal doses of oxytocin agonist.. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1 of 4), MEDLINE (1966 to 1 March 2011) and EMBASE (1974 to 1 March 2011). We checked references of articles and communicated with authors and pharmaceutical industry contacts.. Randomised controlled trials which compared oxytocin agonist (carbetocin) with other uterotonic agents or with placebo or no treatment for the prevention of PPH.. Two review authors independently assessed trials for inclusion, assessed risk of bias and extracted data.. We included 11 studies (2635 women) in the review. Six trials compared carbetocin with oxytocin; four of these were conducted for women undergoing caesarean deliveries, one was for women following vaginal deliveries and one did not state the mode of delivery clearly. The carbetocin was administered as 100 µg intravenous dosage across the trials, while oxytocin was administered intravenously but at varied dosages. Four trials compared intramuscular carbetocin and intramuscular syntometrine for women undergoing vaginal deliveries. Three of the trials were on women with no risk factor for PPH, while one trial was on women with risk factors for PPH. One trial compared the use of intravenous carbetocin with placebo. Use of carbetocin resulted in a statistically significant reduction in the need for therapeutic uterotonics (risk ratio (RR) 0.62; 95% confidence interval (CI) 0.44 to 0.88; four trials, 1173 women) compared to oxytocin for those who underwent caesarean section, but not for vaginal delivery. Compared to oxytocin, carbetocin was associated with a reduced need for uterine massage following both caesarean delivery (RR 0.54; 95% CI 0.37 to 0.79; two trials, 739 women) and vaginal delivery (RR 0.70; 95% CI 0.51 to 0.94; one trial, 160 women). There were no statistically significant differences between carbetocin and oxytocin in terms of risk of any PPH (blood loss greater than 500 ml) or in risk of severe PPH (blood loss greater than 1000 ml). Comparison between carbetocin and syntometrine showed a lower mean blood loss in women who received carbetocin compared to syntometrine (mean difference (MD) -48.84 ml; 95% CI -94.82 to -2.85; four trials, 1030 women). There was no statistically significant difference in terms of the need for therapeutic uterotonic agents, but the risk of adverse effects such as nausea and vomiting were significantly lower in the carbetocin group: nausea (RR 0.24; 95% CI 0.15 to 0.40; four trials, 1030 women); vomiting (RR 0.21; 95% CI 0.11 to 0.39; four trials, 1030 women). The incidence of postpartum hypertension was also significantly lower in women who received carbetocin compared to those who received syntometrine. Cost-effectiveness of carbetocin was investigated by one study published as an abstract, with limited data.. For women who undergo caesarean section, carbetocin resulted in a statistically significant reduction in the need for therapeutic uterotonics compared to oxytocin, but there is no difference in the incidence of postpartum haemorrhage. Carbetocin is associated with less blood loss compared to syntometrine in the prevention of PPH for women who have vaginal deliveries and is associated with significantly fewer adverse effects. Further research is needed to analyse the cost-effectiveness of carbetocin as a uterotonic agent.

Topics: Cesarean Section; Delayed-Action Preparations; Ergonovine; Female; Humans; Injections, Intramuscular; Injections, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

The objective of this review was to evaluate the efficacy and safety of carbetocin in the prevention of postpartum hemorrhage. All trials found during a targeted Medline and Cochrane database search were screened for eligibility. Outcome measures were estimated blood loss, uterine tone, amount and type of lochia, fundal position after delivery (number of centimeters above or below the umbilicus), side-effects, adverse effects, vital signs, levels of hemoglobin/hematocrit before delivery compared with 24 or 48 hours postpartum, the need for additional uterotonic therapy, and/or uterine massage and duration of the third stage of labor. The retrieved studies were difficult to compare because of differences in study design and outcome. We conclude that carbetocin probably is as effective as oxytocin or syntometrine in the prophylactic management of the third stage of labor. Also carbetocin has a similar safety profile to oxytocin, which is now used as a standard prophylactic treatment. However, more research on this subject is needed.

Topics: Female; Humans; Labor Stage, Third; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome

Postpartum haemorrhage is the leading cause of maternal mortality worldwide: 67-80% of cases are caused by uterine atony. Preventive measures include prophylactic drug use to aid uterine contraction after delivery, thus avoiding severe blood loss and reducing maternal morbidity and mortality. Carbetocin is a synthetic analogue of oxytocin with a half-life approximately 4-10 times longer than that reported for oxytocin. It combines the safety and tolerability profile of oxytocin with the sustained uterotonic activity of injectable ergot alkaloids. Furthermore, carbetocin can be administered as a single dose injection either intravenously or intramuscularly rather than as an infusion over several hours as is the case with oxytocin. Carbetocin is currently indicated for prevention of uterine atony after delivery by caesarean section in spinal or epidural anaesthesia. Data from three randomised controlled trials in caesarean delivery and a meta-analysis indicate that carbetocin significantly reduces the need for additional uterotonic agents or uterine massage to prevent excessive bleeding compared with placebo or oxytocin. The risk of headache, tremor, hypotension, flushing, nausea, abdominal pain, pruritus and feeling of warmth was similar in women who received carbetocin or oxytocin. The findings from two more recent double-blind randomised trials and one retrospective study suggest that carbetocin may also represent a good alternative to conventional uterotonic agents for prevention of postpartum haemorrhage after vaginal deliveries. A reduced need for additional uterotonics was observed with carbetocin vs. oxytocin in high-risk women and carbetocin was at least as effective as syntometrine in low-risk women. In these studies of vaginal deliveries, carbetocin was associated with a low incidence of adverse effects and demonstrated a better tolerability profile than syntometrine. Carbetocin had a long duration of action compared with intravenous oxytocin alone and a better cardiovascular side effect profile compared with syntometrine. In addition to being an effective treatment for the prevention of postpartum haemorrhage following caesarean delivery, carbetocin may also become the drug of choice for postpartum haemorrhage prevention after vaginal delivery in high-risk women and those who suffer from hypertensive disorders in pregnancy. Preeclampsia is still a contraindication to the administration of carbetocin in the EU, and further studies would be requir

Topics: Blood Pressure; Cost-Benefit Analysis; Female; Humans; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome; Uterine Contraction

Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side-effects. Carbetocin, a long-acting oxytocin agonist appears to be a promising agent for the prevention of PPH.. To determine if the use of oxytocin agonist is as effective as conventional uterotonic agents for the prevention of PPH, and assess the best routes of administration and optimal doses of oxytocin agonist.. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (September 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2006, Issue 2), MEDLINE (1966 to June 2006) and EMBASE (1974 to June 2006). We checked references of articles and communicated with authors and pharmaceutical industry.. Randomised controlled trials which compared oxytocin agonist (carbetocin) with other uterotonic agents or with placebo or no treatment for the prevention of PPH.. Two review authors independently extracted data and assessed trial quality.. Four studies (1037 women) were included in the review (three studies on caesarean delivery and one on vaginal delivery). The risk of PPH was similar in both oxytocin and carbetocin arms for participants who underwent caesarean delivery as well as participants, with risk factor(s) for PPH, who underwent vaginal delivery. Use of carbetocin resulted in a statistically significant reduction in the need for therapeutic uterotonic agent (relative risk (RR) 0.44, 95% confidence interval (CI) 0.25 to 0.78) compared to oxytocin for those who underwent caesarean section, but not for vaginal delivery. Carbetocin is also associated with a reduced need for uterine massage in both caesarean and vaginal deliveries (RR 0.38, 95% CI 0.18 to 0.80; RR 0.70, 95% CI 0.51 to 0.94) respectively. However, this outcome measure was only documented in one study on caesarean delivery and in the only study on vaginal delivery. Pooled data from the trials did not reveal any statistically significant differences in terms of the adverse effects between carbetocin and oxytocin.. There is insufficient evidence that 100 micrograms of intravenous carbetocin is as effective as oxytocin to prevent PPH. In comparison to oxytocin, carbetocin was associated with reduced need for additional uterotonic agents, and uterine massage. There was limited comparative evidence on adverse events.

Topics: Delayed-Action Preparations; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Despite evidence that active management of the third stage of labour reduces the incidence of postpartum haemorrhage, expectant management is still widely practised. Factors accounting for this situation include the desire for a more natural experience of childbirth, the philosophy that active management is unnecessary in low-risk women, and avoidance of the adverse effects of conventional uterotonic agents. This review will evaluate the various strategies currently used for the prevention of primary postpartum haemorrhage.. Since publication of the first systematic review comparing active with expectant management in 1988, active management of the third stage using oxytocics has become increasingly adopted. Recent surveys, however, show that there are still wide variations in practice around the world. Recent interest has focused on the use of misoprostol for the prevention of postpartum haemorrhage. Carbetocin, an oxytocin receptor agonist, shows promise but has not been evaluated for use after vaginal births.. Active management of the third stage of labour is superior to expectant management in terms of blood loss, postpartum haemorrhage and other serious complications, but is associated with unpleasant side effects and hypertension when ergometrine is included. Intramuscular oxytocin results in fewer side effects. Oral and rectal misoprostol has been extensively assessed and found to be less effective than conventional oxytocics with more side effects. Until alternative regimes of misoprostol are studied in large controlled trials, misoprostol is not recommended for routine use in the third stage of labour. Of the remaining uterotonic agents evaluated, intramuscular carbetocin appears the most promising.

Topics: Delivery, Obstetric; Ergonovine; Female; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prostaglandins; Randomized Controlled Trials as Topic

To evaluate the uterotonic effect of carbetocin compared with oxytocin in emergency cesarean delivery in Iraq.. A double-blinded randomized noninferiority single center trial. Three-hundred patients were systematically randomized to intravenous bolus injection of 10 IU oxytocin or 100 mcg carbetocin after delivery in a ratio of 2:1. The primary outcome was additional uterotonic use when inadequate uterine tone occur in the first 24 h after delivery. Secondary outcomes include the need for blood transfusion, blood pressure and pulse rate changes within an hour of drugs administration. Noninferiority margins for the relative risks outcomes was 4%.. Addition uterotonics use was significantly lower in carbetocin group with a risk ratio of 0.36. Carbetocin was superior to oxytocin in reducing the need for additional uterotonic drugs by 12% and non-inferior to oxytocin for blood transfusion 3.5%. Noninferiority was not shown for the outcome of sever blood loss. Miner changes in blood pressure and pulse rate were observed in carbetocin group compared to oxytocin but clinically were not significant.. Heat stable carbetocin is effective in reducing additional uterotonics use compared to oxytocin without clinically significant change in blood pressure or pulse rate, therefore, can be a potential alternative in Iraq.

Topics: Cesarean Section; Female; Hot Temperature; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Postpartum Period; Pregnancy

To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level.. Hospital based study in Southern India.. Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin with oxytocin administered immediately after vaginal birth in women across 23 sites in 10 countries.. This was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM, administered within one minute of vaginal delivery of the baby for prevention of postpartum hemorrhage, on post-delivery 48-72 h hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study.. The present ancillary study showed that intramuscular administration of 100 µg of heat stable carbetocin can result in a slightly lower post-delivery hemoglobin, slightly higher drop and higher percentage of women having a drop of 2 g/dL or larger, compared to 10 IU of oxytocin.

Topics: Female; Hemoglobin A; Hemoglobins; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Carbetocin or oxytocin are given routinely as first-line uterotonic drugs following delivery of the neonate during caesarean delivery to prevent postpartum haemorrhage. Low doses may be as effective as high doses with a potential reduction in adverse effects. In this double-blind, randomised, controlled, non-inferiority trial, we assigned low-risk patients undergoing elective caesarean delivery under spinal anaesthesia to one of four groups: carbetocin 20 μg; carbetocin 100 μg; oxytocin 0.5 IU bolus + infusion; and oxytocin 5 IU bolus + infusion. The study drug was given intravenously after delivery of the neonate. Uterine tone was assessed by the obstetrician 2, 5 and 10 minutes after study drug administration according to an 11-point verbal numerical rating scale (0 = atonic, 10 = excellent tone). The primary outcome measure was uterine tone 2 min after study drug administration. The pre-specified non-inferiority margin was 1.2 points on the 11-point scale. Secondary outcomes included uterine tone after 5 and 10 minutes, use of additional uterotonics, blood loss and adverse effects. Data were available for 277 patients. Carbetocin 20 μg resulting in uterine tone of (median (IQR [range])) 8 (7-8 [1-10]) was non-inferior to carbetocin 100 μg with tone 8 (7-9 [3-10]), median (95%CI) difference 0 (-0.44-0.44). Similarly, oxytocin 0.5 IU with tone 7 (6-8 [3-10]) was non-inferior to oxytocin 5 IU with tone 8 (6-8 [2-10]), median (95%CI) difference 1 (0.11-1.89). Carbetocin 20 μg was also non-inferior to oxytocin 5 IU, and oxytocin 0.5 IU was non-inferior to carbetocin 100 μg. Uterine tone after 5 and 10 minutes, use of additional uterotonics, blood loss and adverse effects were similar in all groups.

Topics: Cesarean Section; Double-Blind Method; Female; Humans; Infant, Newborn; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Oxytocin can stimulate release of myocardial biomarkers troponin I and T, prolong QTc and induce ST-depression.. To explore cardiac changes after either intravenous carbetocin or oxytocin.. Exploratory phase 4 randomised controlled trial.. Obstetrics units of Oslo University Hospital, Norway between September 2015 and May 2018.. Forty healthy, singleton pregnant women aged 18 to 50 years at gestational age at least 36 weeks with a planned caesarean delivery.. Participants were randomised to receive either oxytocin 2.5 IU or carbetocin 100 μg immediately after delivery.. The primary endpoint was the assessment of troponin I within 48 h of study drug administration. Troponin I and T, and creatine kinase myocardial band assessments were measured before spinal anaesthesia (baseline), and again at 4, 10 and 24 h after delivery. QTc, ST-depression and relative increase in heart rate were recorded from start of study drug administration to 10 min after delivery. All adverse events were monitored.. Compared with the carbetocin group, higher troponin I levels were observed in the oxytocin group at 4 h and 10 h after delivery. For both treatment groups, an increase from baseline in troponin I and T was most pronounced at 10 h after delivery, and it had begun to decline by 24 h. QTc increased with time after administration of both study drugs, with a mean maximum increase of 10.4 ms observed at 9 min (P   <  0.001). No statistical differences were observed in QTc ( P  = 0.13) or ST-depression ( P  = 0.11) between the treatment groups.. Oxytocin 2.5 IU and carbetocin 100 μg caused a similar increase in QTc. The trial was underpowered with regards to ST-depression and the release of myocardial biomarkers and these warrant further investigation. Data from this trial will inform a larger phase 4 trial to determine potential drug differences in troponin release.. ClinicalTrials.gov Identifier: NCT02528136.

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Troponin I

Electrohysterography has been used for monitoring uterine contractility in pregnancy and labour. Effective uterine contractility is crucial for preventing postpartum haemorrhage. The objective of our study was to compare postpartum electrohysterograms in women receiving oxytocin vs. carbetocin for postpartum haemorrhage prevention after caesarean delivery. The trial is registered at ClinicalTrials.gov with the identifier NCT04201665. We included 64 healthy women with uncomplicated singleton pregnancies at term scheduled for caesarean section after one previous caesarean section. After surgery, a 15 min electrohysterogram was obtained after which women were randomised to receive either five IU of oxytocin intravenously or 100 μg of carbetocin intramuscularly. A 30 min electrohysterogram was performed two hours after drug application. Changes in power density spectrum peak frequency of electrohysterogram pseudo-bursts were analysed. A significant reduction in power density spectrum peak frequency in the first two hours was observed after carbetocin but not after oxytocin (median = 0.07 (interquartile range (IQR): 0.87 Hz) compared to median = -0.63 (IQR: 0.20) Hz;

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

To compare intramuscular oxytocin, Syntometrine. Randomised double-blinded clinical trial.. Six hospitals in England.. A total of 5929 normotensive women having a singleton vaginal birth.. Randomisation when birth was imminent.. Primary: use of additional uterotonic agents. Secondary: weighed blood loss, transfusion, manual removal of placenta, adverse effects, quality of life.. Participants receiving additional uterotonics: 368 (19.5%) oxytocin, 298 (15.6%) Syntometrine and 364 (19.1%) carbetocin. When pairwise comparisons were made: women receiving carbetocin were significantly more likely to receive additional uterotonics than those receiving Syntometrine (odds ratio [OR] 1.28, 95% CI 1.08-1.51, P = 0.004); the difference between carbetocin and oxytocin was non-significant (P = 0.78); Participants receiving Syntometrine were significantly less likely to receive additional uterotonics than those receiving oxytocin (OR 0.75, 95% CI 0.65-0.91, P = 0.002). Non-inferiority between carbetocin and Syntometrine was not shown. Use of Syntometrine reduced non-drug PPH treatments compared with oxytocin (OR 0.64, 95% CI 0.42-0.97) but not carbetocin (P = 0.64). Rates of PPH and blood transfusion were not different. Syntometrine was associated with an increase in maternal adverse effects and reduced ability of the mother to bond with her baby.. Non-inferiority of carbetocin to Syntometrine was not shown. Carbetocin is not significantly different to oxytocin for use of additional uterotonics. Use of Syntometrine reduced use of additional uterotonics and need for non-drug PPH treatments compared with oxytocin. Increased maternal adverse effects are a disadvantage of Syntometrine.. IM carbetocin does not reduce additional uterotonic use compared with IM Syntometrine or oxytocin.

Topics: Adult; Blood Transfusion; Delivery, Obstetric; Double-Blind Method; Ergonovine; Female; Humans; Hypertension; Injections, Intramuscular; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Puerperal Disorders; Quality of Life

To compare effectiveness and safety of carbetocin and misoprostol for prevention of postpartum hemorrhage (PPH) among low-risk women.. Randomized controlled trial among 150 pregnant women with low risk of PPH admitted for vaginal delivery at Kasr Al Ainy Hospital, Cairo, Egypt, between July 2018 and May 2019. Participants were assigned to two groups by a web-based randomization system ensuring allocation concealment. After neonatal delivery, the carbetocin group received one ampoule of carbetocin (100 μg/mL) intravenously and the misoprostol group received two rectal tablets of misoprostol (800 μg) for active management of the third stage. Blood pressure, blood loss, and hemoglobin levels were monitored. The primary outcome measure was need for additional uterotonic drugs.. The carbetocin group had significantly less blood loss (P<0.001), shorter third stage (P<0.001), and less need for additional uterotonics (P=0.013) or uterine massage (P=0.007). The two drugs were hemodynamically safe. Hemoglobin levels after delivery were comparable in the two groups (P=0.475). Adverse effects were more common in the misoprostol group (P<0.001).. Among low-risk women, carbetocin seems to be a better alternative to misoprostol for active management of the third stage of labor; it reduced blood loss and use of additional uterotonic drugs. CLINICALTRIALS.GOV: NCT03556852.

Topics: Administration, Oral; Administration, Rectal; Adult; Egypt; Female; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Postpartum haemorrhage is a leading cause of maternal death during childbirth. There is an increasing incidence of atonic postpartum haemorrhage in developed countries, and maternal obesity has been proposed as a contributing factor. The dose-response relationship of carbetocin in obese women has not yet been determined. We conducted a double-blind, dose-finding study of carbetocin using a biased coin up-and-down design in women with a body mass index ≥ 40 kg.m

Topics: Adult; Blood Loss, Surgical; Body Mass Index; Cesarean Section; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Obesity; Oxytocics; Oxytocin; Postoperative Complications; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Treatment Outcome; Uterus

Assess the efficacy and safety of carbetocin, versus oxytocin in the prevention of postpartum hemorrhage in hypertensive women.. A randomized clinical trial.. Obstetrics and Gynecology Department of Suez Canal University Hospital.. One hundred and sixty hypertensive pregnant women who underwent CS.. Patients were randomized to receive either 10 IU oxytocin or 100 μg carbetocin. Primary outcomes included estimated blood loss, blood transfusion, hemoglobin (HB), and hematocrit changes pre- and post-delivery and the use of additional uterotonics.. The postoperative HB was not different from preoperative HB in the carbetocin group (11.8 ± 1.2 vs. 11.2 ± 1.2 g/dL) while it decreased significantly in the oxytocin group (12.1 ± 3.8 vs. 10.4 ± 1.1 g/dL, p < 0.001). Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001). Nausea, vomiting, and sweating were reported more significantly in oxytocin group patients.. Carbetocin was more effective than oxytocin in reducing intraoperative and postoperative blood loss.

Topics: Adult; Cesarean Section; Double-Blind Method; Female; Humans; Hypertension, Pregnancy-Induced; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome

Retained placenta can be defined as lack of expulsion of the placenta within 30 min of delivery of the infant. It is a significant cause of maternal mortality and morbidity throughout the developing world.. The aim of this study was to compare the efficacy of intra-umbilical vein injection of carbetocin versus oxytocin in the management of retained placenta.. A total of 200 women were included in this study. They were divided into two groups; each 100 women. The first group received intra-umbilical vein injection of 1 mL carbetocin (containing 100 μg carbetocin) diluted in 20 mL normal saline 0.9% and the second group received intra-umbilical vein injection of 20 IU oxytocin diluted in 20 mL normal saline 0.9%.. Total blood loss (ml) and duration of the third stage of labor (minutes) were significantly lower in carbetocin group when compared to oxytocin group. Postoperative Hb concentration (g/dl) was significantly higher in carbetocin group. Also there was a highly significant difference between both groups as regard change in Hb concentration (g/dl) with less change in the carbetocin group. The need for additional uterotonic drugs following placental delivery and the occurrence of postpartum hemorrhage and the need for blood transfusion were significantly lower in the carbetocin group.. Intra-umbilical carbetocin is more effective than intra-umbilical oytocin as a method for management of retained placenta. Intra-umbilical carbetocin seems to have more acceptable hemodynamic safety profile when compared to intra-umbilical oxytocin in the management of retained placenta.

Topics: Adult; Blood Transfusion; Blood Volume; Double-Blind Method; Female; Hemoglobins; Humans; Injections, Intravenous; Oxytocics; Oxytocin; Placenta, Retained; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Umbilical Veins; Young Adult

Postpartum haemorrhage remains a major cause of maternal mortality and morbidity worldwide. Active management of the third stage of labour reduces the risk of postpartum haemorrhage. Oxytocin and oxytocin/ergometrine are commonly used in the UK, with oxytocin/ergometrine being more effective at preventing moderate, but not severe, blood loss. Many guidelines specifically recommend using oxytocin for all vaginal births, as it is associated with fewer adverse events. However, a survey conducted by the Southmead Hospital Maternity Research Team revealed that 71.4% of UK obstetric units still routinely use oxytocin/ergometrine. Carbetocin is a newer medication that may be as effective but has fewer side effects. No studies have directly compared all three medications.. The IMox study aims to determine the most effective, acceptable and cost-effective drug for primary prevention of postpartum haemorrhage following vaginal birth. The IMox study is a prospective, multi-centre, double-blind, randomised trial directly comparing oxytocin, oxytocin/ergometrine and carbetocin given intramuscularly for the prevention of postpartum haemorrhage in the third stage of labour. The primary effectiveness outcome is the use of an additional uterotonic drug. Secondary effectiveness outcomes reflect maternal morbidity and mortality within the immediate postpartum period. Participant questionnaires and subjective reporting of side effects will be used to evaluate maternal acceptability. Maternal quality of life utilities will be collected antenatally, and on days 1 and 14 after birth to enable a cost-effectiveness assessment of each studied drug. Participants will be pregnant women planning a vaginal birth in six hospitals in England. Participants will be approached and invited to provide consent to participate from 20 weeks gestation until in established labour. A complete sample of 5712 participants (1904 per arm) providing data for the primary outcome will allow for a robust determination of efficacy between all three study drugs. Data will be collected until participants are discharged from the hospital and on postnatal days 1 and 14 regardless of location. All analyses will be on a modified intention-to-treat basis, and additionally repeated on a per protocol basis. Data collection commenced in Feburary 2015 and was completed in August 2018.. This study is the first to directly compare oxytocin, oxytocin/ergometrine and carbetocin in the same population for the prevention of postpartum haemorrhage following vaginal birth. Furthermore, this study will be the first to directly compute health economic outcomes from such a three-way comparison. This study is limited to using short-term outcomes, and so will not provide evidence for important outcomes such as long-term maternal psychological well-being and time to next conception.. ClinicalTrials.gov, NCT02216383 . Registered on 18 August 2014. EudraCT, 2014-001948-37. Registered on 23 September 2014. ISRCTN, ISRCTN10232550. Retrospectively registered on 6 March 2018).

Topics: Cost-Benefit Analysis; Data Collection; Double-Blind Method; Drug Combinations; Ergonovine; Humans; Injections, Intramuscular; Multicenter Studies as Topic; Outcome Assessment, Health Care; Oxytocin; Postpartum Hemorrhage; Randomized Controlled Trials as Topic; Sample Size

To compare the use of carbetocin and oxytocin in the prevention of postpartum hemorrhage after cesarean section.. The present study was a prospective double-blind randomized controlled clinical trial performed in two university-based hospitals in Tehran, Iran. Two hundred and twenty women with the gestational age of more than 37 weeks, who needed cesarean operation, participated in the study. Patients were assigned to receive either a single 100 μg IV dose of carbetocin or a standard 30-international unit IV infusion of oxytocin during 2 h after delivery of placenta. The primary outcome measures were postpartum hemorrhage requiring additional uterotonic drugs, bleeding volume, and the hemoglobin drops.. There were meaningful differences in carbetocin versus oxytocin group regarding the hemoglobin drops (1.01 versus 2.05, p = .01), bleeding volume (430.68 CC versus 552.6 CC, p < .001), uterine massages frequency (3.7 versus 4.26, p < .001), and uterine height at 2, 4, and 24 h (p < .001). Oxytocin side effects were significantly higher in comparison with the carbetocin except pruritus which was observed in 27% of patients in the carbetocin versus no cases in the oxytocin group.. It may be concluded that carbetocin is a good alternative modality to conventional uterotonic agents such as oxytocin for the prevention of postpartum hemorrhage after cesarean sections. Registration ID in IRCT: NCT02079558.

Topics: Adult; Anesthesia, General; Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postoperative Complications; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Young Adult

To compare the incidence of nausea, vomiting, and arterial hypotension between carbetocin and oxytocin to prevent haemorrhage after caesarean section (CS).. A randomized controlled trial in term pregnant women undergoing planned CS. Groups were randomized to carbetocin or oxytocin. Blood pressure (BP), heart rate, presence of nausea/vomitus, and need for vasopressors were evaluated throughout surgery. Preoperative and postoperative haemoglobin and haematocrit levels were compared.. Fifty-eight women were randomized (carbetocin. In planned CS, a possible clinical significant lower incidence of nausea after carbetocin was noted but this was not statistically significant. There were no differences regarding BP, heart rate, the need for vasopressor, and blood loss. The study was registered in the International Journal of Clinical Trials (ISRCTN 95504420, 2/2017).

Topics: Adult; Blood Pressure; Cesarean Section; Female; Heart Rate; Humans; Oxytocics; Oxytocin; Postoperative Nausea and Vomiting; Postpartum Hemorrhage; Pregnancy

To compare the effectiveness of intravenous carbetocin to that of intravenous oxytocin for prevention of atonic postpartum hemorrhage (PPH) after vaginal delivery in high-risk singleton pregnancies.. This triple-blind randomized controlled trial included singleton pregnant women who delivered at Siriraj Hospital between August 2016 and January 2017 and who were 20 years or older, had a gestational age of at least 34 weeks, had a vaginal delivery, and had at least one risk factor for atonic postpartum hemorrhage. Immediately after vaginal delivery, participants were randomly assigned to receive either 5 U of oxytocin or 100 mcg of carbetocin intravenously. Postpartum blood loss was measured objectively in mL using a postpartum drape with a calibrated bag.. A total of 174 and 176 participants constituted the oxytocin and carbetocin groups, respectively. The baseline characteristics were comparable between the groups. The carbetocin group had less postpartum blood loss (146.7 ± 90.4 vs. 195.1 ± 146.2 mL; p < 0.01), a lower incidence of atonic PPH (0 vs. 6.3%; p < 0.01), less usage of additional uterotonic drugs (9.1 vs. 27.6%; p < 0.01), and a lower incidence of postpartum anemia (Hb ≤ 10 g/dL) (9.1 vs. 18.4%; p < 0.05) than the oxytocin group. No significant differences regarding side effects were evident between the groups.. Intravenous carbetocin is more effective than intravenous oxytocin for the prevention of atonic PPH among singleton pregnancies with at least one risk factor for PPH.. TCTR20160715004.

Topics: Administration, Intravenous; Adult; Delivery, Obstetric; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy, High-Risk

Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin.. We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 μg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively.. A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups.. Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).

Topics: Adult; Double-Blind Method; Drug Stability; Female; Humans; Injections, Intramuscular; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Risk; Young Adult

The third stage of labour is considered to be the most critical part of child birth due to the risk of post partum haemorrhage (PPH). To compare the effectiveness of carbetocin and oxytocin in the management of 3rd stage of labour in preventing post partum hemorrhage, this experimental clinical trial was conducted in the Department of Obstetrics and Gynecology, Sir Salimulla Medical College Hospital, Dhaka, Bangladesh from January 2015 to June 2016. Three hundred women undergoing normal vaginal delivery were consecutively enrolled. They were divided into two groups, one group was treated with carbetocin 100μg IV and another group was treated with oxytocin 10 unit IV. Post partum haemorrhage was developed in 23(15.3%) and 31(20.7%) patients in carbetocin and oxytocin groups respectively. Among these PPH patients, 17(73.9%) patients received oxytocin, 21(91.3%) patients received Ergometrin and 14(60.9%) patients received misoprostol in carbetocin group as additional drug. In oxytocin group 30(96.8) patients received ergometrin and 26(83.9) patients received misoprostol. Significantly higher number of patients was treated with balloon catheter in oxytocin group (77.4%) than carbetocin group (39.1%). Thirteen (41.9%) patients in oxytocin group and 4(17.4%) patients in carbetocin group needed to treat in ICU. In carbetocin Group I patient (4.3%) and in oxytocin Group II patients (6.5%) died. carbetocin is better than oxytocin in the management of 3rd stage of labour to prevent post partum haemorrhage (PPH).

Topics: Adult; Bangladesh; Comparative Effectiveness Research; Delivery, Obstetric; Female; Humans; Labor Stage, Third; Labor, Obstetric; Outcome Assessment, Health Care; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Carbetocin is a synthetic oxytocin-analogue, which should be administered as bolus according to manufacturer's recommendations. A higher speed of oxytocin administration leads to increased cardiovascular side-effects. It is unclear whether carbetocin administration as short infusion has the same efficacy on uterine tone compared with bolus administration and whether haemodynamic parameters differ.. In this randomized, double-blind, non-inferiority trial, women undergoing planned or unplanned Caesarean section (CS) under regional anaesthesia received a bolus and a short infusion, only one of which contained carbetocin 100 mcg (double dummy). Obstetricians quantified uterine tone two, three, five and 10 min after cord-clamping by manual palpation using a linear analogue scale from 0 to 100. We evaluated whether the lower limit of the 95% CI of the difference in maximum uterine tone within the first five min after cord-clamping did not include the pre-specified non-inferiority limit of -10.. Between December 2014 and November 2015, 69 patients were randomized to receive carbetocin as bolus and 71 to receive it as short infusion. Maximal uterine tone was 89 in the bolus and 88 in the short infusion group (mean difference -1.3, 95% CI -5.7 to 3.1). Bp, calculated blood loss, use of additional uterotonics, and side-effects were comparable.. Administration of carbetocin as short infusion does not compromise uterine tone and has similar cardiovascular side-effects as a slow i.v. bolus. In accordance with current recommendations for oxytocin, carbetocin can safely be administered as short -infusion during planned or unplanned CS.. ClinicalTrials.gov NCT02221531 and www.kofam.ch SNCTP000001197.

Topics: Adult; Cesarean Section; Double-Blind Method; Female; Hemodynamics; Humans; Infusions, Intravenous; Injections, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome; Uterine Contraction

To compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of postpartum hemorrhage (PPH) after cesarean section (CS).. A double-blind randomized study conducted on 300 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (150 women) after fetal extraction and before placental removal. Primary outcome parameter was the occurrence of PPH. Other parameters were hemoglobin and hematocrit changes, the need of additional oxytocic, hemodynamic changes and occurrence of side effects.. There was no significant difference between the two study groups regarding hemoglobin and hematocrit at start of CS and after 2 days of surgery and mean blood loss during the operation (p > 0.05). There was a highly significant difference between the two study groups regarding incidence of primary PPH (2.7% versus10%) and the need of additional oxytocic (3.3% versus17.3%). Women in oxytocin group showed a statistically significant lower systolic and diastolic blood pressure at 1, 5 and 30 min than women in carbetocin group. Women in carbetocin group experienced more metallic taste, flushing, headache, dizziness, dyspnea and itching, while women in oxytocin methergine group experienced more palpitations.. Carbetocin is a reasonable effective alternative to syntometrine in prevention of PPH after cesarean delivery.

Topics: Adult; Cesarean Section; Double-Blind Method; Ergonovine; Female; Humans; Infant, Newborn; Oxytocics; Oxytocin; Postoperative Hemorrhage; Postpartum Hemorrhage; Pregnancy; Puerperal Disorders; Young Adult

To compare effectiveness and tolerability of carbetocin versus oxytocin in prevention of postpartum hemorrhage (PPH) after vaginal delivery.. A prospective double-blinded randomized study conducted on 200 pregnant women randomized into two groups: Group 1 (100 women) received single 100 μg IM dose of carbetocin and Group 2 received of 5 IU oxytocin IM. Both groups received their drug after fetal and before placental delivery.. There was a statistically significant difference between the two study groups regarding amount of bleeding (337.73 ± 118.77 versus 378 ± 143.2), occurrence of PPH (4 versus 16%), need for other uterotonics (23 versus 37%) and hemoglobin difference between before and after delivery (0.55 ± 0.35 versus 0.96 ± 0.62) (all being lower in carbetocin group) and measured hemoglobin 24 h after delivery (being higher in carbetocin group); however, there was no significant difference between the two study groups regarding occurrence of major PPH and the need for blood transfusion. Women in carbetocin group showed a statistically significant lower systolic and diastolic blood pressure immediately after delivery and at 30 and 60 min than women in oxytocin group. There was no significant difference between the two study groups regarding occurrence of nausea, vomiting, flushing, dizziness, headache, shivering, metallic taste, dyspnea, palpitation and itching. Women in carbetocin group experienced tachycardia more than women in oxytocin group.. Carbitocin is a better alternative to traditional oxytocin in prevention of PPH after vaginal delivery with minimal hemodynamic changes and similar side effects.

Topics: Adult; Blood Pressure; Delivery, Obstetric; Double-Blind Method; Female; Hemoglobins; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Tachycardia

To study the efficacy of 100 μg intravenous shot of carbetocin compared to 20 IU oxytocin intravenous infusion to prevent placental retention in second trimester medical termination of pregnancy.. A double-blinded randomized controlled trial was conducted at Ain Shams University Maternity Hospital from 1 April 2013 to 30 November 2013. A total of 132 women between 14 and 24 weeks gestation indicated for termination were randomized to receive either 20 IU oxytocin infusion (n = 66) or 100 μg carbetocin shot (n = 66) after fetal expulsion. Patients were observed for time elapsed between fetal and placental expulsion, presence of placental retention and blood loss.. Third stage was 33.4 ± 20.4 min in oxytocin group & 23.1 ± 16.8 min in carbetocin group (p = 0.002). Eight patients (12.1%) in oxytocin group had complete placental retention versus two patients (3.0%) in carbetocin group (p = 0.05). Eight patients (13.8%) received oxytocin had remnants of placenta compared to four patients (6.2%) received carbetocin (p = 0.04). Sixteen patients (24.2%) received oxytocin and six patients (9%) received carbetocin needed surgical curettage (p = 0.04). Third stage blood loss was 87.2 ± 33.7 ml in carbetocin and 206.9 ± 35.2 ml in oxytocin groups (p = 0.001).. Carbetocin is superior to oxytocin infusion for management of placental delivery in second trimester abortion.

Topics: Abortion, Eugenic; Administration, Intravenous; Adult; Female; Humans; Infant, Newborn; Oxytocin; Pilot Projects; Placenta; Placenta, Retained; Postpartum Hemorrhage; Pregnancy; Pregnancy Trimester, Second; Treatment Outcome; Young Adult

To assess and compare the effectiveness and safety of single IV polus dose of carbetocin, versus IV oxytocin infusion in the prevention of PPH in obese nulliparous women undergoing emergency Cesarean Delivery.. A double-blinded randomized-controlled trial was conducted on 180 pregnant women with BMI >30. Women were randomized to receive either oxytocin or carbetocin during C.S. The primary outcome measure was major primary PPH >1000 ml within 24 h of delivery as per the definition of PPH by the World Health Organization Secondary outcome measures were hemoglobin and hematocrit changes pre- and post-delivery, use of further ecobolics, uterine tone 2 and 12-h postpartum and adverse effects.. A significant difference in the amount of estimated blood loss or the incidence of primary postpartum haemorrhage (>1000 ml) in both groups. Haemoglobin levels before and 24-h postpartum was similar. None from the carbetocin group versus 71.5% in oxytocin group needed additional utrotonics (p < 0.01). The uterine contractility was better in the carbetocin group at 2, and 12-h postpartum (p < 0.05).. A single 100-µg IV carbetocin is more effective than IV oxytocin infusion for maintaining adequate uterine tone and preventing postpartum bleeding in obese nulliparous women undergoing emergency cesarean delivery, both has similar safety profile and minor hemodynamic effect.

Topics: Adult; Cesarean Section; Double-Blind Method; Emergencies; Female; Hemoglobins; Humans; Obesity; Oxytocics; Oxytocin; Parity; Postpartum Hemorrhage; Pregnancy; Uterine Contraction

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin in the management of atonic post partum haemorrhage (PPH) after vaginal delivery.. A prospective randomised study was conducted in which 100 pregnant women were randomised into 2 equal groups: group 1 received Carbetocin 100 µgm (Pabal(®) Ferring, UK) and group 2 received oxytocin 5 IU (Syntocinon(®), Novartis, Switzerland).. The amount of blood loss and the need for other uterotonics were significantly lower in the carbetocin group (811 ± 389.17 vs. 1010 ± 525.66 and 10/50 vs. 21/50). There was no significant difference between the carbetocin and oxytocin groups regarding occurrence of major PPH (6 vs. 11), the need for blood transfusion (6 vs. 9), the difference between blood haemoglobin levels before delivery and 24 h after delivery (0.6 ± 0.28 vs. 0.56 ± 0.25), respectively. There was no significant difference between the 2 study groups regarding both systolic and diastolic blood pressure measured immediately after the drug administration and at 30 and 60 min later. Regarding the drugs side effects, there was no significant difference between the 2 groups in the occurrence of nausea, vomiting, tachycardia, flushing, dizziness, headache, shivering, metallic taste, dyspnea, palpitations and itching.. Carbetocin is a better alternative to oxytocin in management of atonic PPH with non-significant hemodynamic changes or side effects .

Topics: Adult; Blood Pressure; Delivery, Obstetric; Dizziness; Double-Blind Method; Female; Headache; Humans; Nausea; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Switzerland; Treatment Outcome; Vertigo; Vomiting

We compared the efficacy of Carbetocin (long-acting oxytocin receptor agonist) versus Oxytocin given at non-elective caesarean section.. We performed a double-blind, randomised, single-centre study. Eligible women were ≥37 weeks of gestation undergoing emergency caesarean section. Participants received either carbetocin of 100 μg or oxytocin 5 international units. The primary outcome was the need to administer additional uterotonics, as determined by the clinician. Secondary outcomes included estimated blood loss, haemoglobin drop pre-post operation and the need for a blood transfusion Results: From August 2012 to February 2013, 114 women were enroled. Two were excluded from analysis as they received a general anaesthetic. Fifty-nine patients received 100-μg carbetocin; 53 received 5 international units oxytocin. There was no statistically significant difference in the number of women requiring additional uterotonics between the two groups: Carbetocin group 22% and Oxytocin group 13% (p = 0.323). There were no significant differences in the fall in haemoglobin, estimated blood loss, rates of post-partum haemorrhage or blood transfusions.. Oxytocin and carbetocin have similar requirements for additional uterotonics, estimated blood loss, haemoglobin drop and blood transfusions. There was a trend towards requiring additional uterotonics in patients receiving Carbetocin which was not statistically significant. This study found no benefits in using carbetocin over oxytocin.

Topics: Adult; Cesarean Section; Double-Blind Method; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Young Adult

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth.. Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding margin, non-inferiority will have been demonstrated. The safety analysis will include all women receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing with significance levels for between-group comparisons.. If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide.. ACTRN12614000870651 (14 August 2014).

Topics: Clinical Protocols; Delivery, Obstetric; Double-Blind Method; Drug Compounding; Drug Stability; Female; Humans; Labor Stage, Third; Oxytocics; Oxytocin; Parturition; Postpartum Hemorrhage; Pregnancy; Research Design; Risk Factors; Temperature; Time Factors; Treatment Outcome

To compare the effectiveness and safety of carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following cesarean deliveries.. A double-blind randomized controlled trial enrolled patients with a singleton pregnancy scheduled for an elective cesarean delivery at a maternity hospital in Cairo, Egypt, between October 1, 2012 and June 30, 2013. Participants were randomized using a computer-generated sequence to receive treatment with carbetocin, misoprostol, or oxytocin. The primary outcome was the occurrence of uterine atony necessitating additional uterotonics. Per-protocol analyses were performed. Patients, investigators, and data analysts were masked to treatment assignments.. The present study enrolled 263 patients; data were analyzed from 88 patients treated with carbetocin, 89 treated with misoprostol, and 86 women treated with oxytocin. Further uterotonics were needed for the treatment of 5 (6%) patients who were treated with carbetocin, 20 (22%) patients treated with misoprostol, and 11 (13%) patients treated with oxytocin. In the prevention of uterine atony, carbetocin was comparable with oxytocin (RR 0.41, 95%CI 0.14-1.25) and superior to misoprostol (RR 0.21, 95%CI 0.07-0.58).. Additional uterotonics were needed less frequently by patients treated with carbetocin. Carbetocin was comparable to oxytocin and superior to misoprostol in the prevention of uterine atony following an elective cesarean delivery. ClinicalTrials.gov: NCT02053922.

Topics: Adult; Cesarean Section; Egypt; Elective Surgical Procedures; Female; Humans; Misoprostol; Oxytocics; Oxytocin; Perinatal Care; Postpartum Hemorrhage; Pregnancy; Treatment Outcome

In Mexico, during 2010, obstetric hemorrhage was second (19.6%) as a direct cause of maternal death. The aim of this paper is to evaluate the effect of oxytocin and carbetocin, in preventing postpartum hemorrhage in patients with risk factors for uterine atony.. Study type clinical trial, patients experiencing at least one of the risk factors for uterine atony included. Randomly, they were divided into two groups: one was given Oxytocin and other received Carbetocin. The following variables were determined: risk factors for uterine atony, hemoglobin and hematocrit, vital signs, trans-surgical bleeding, whether or not presented uterine atony, uresis, need for additional tonics uterus and need for blood transfusion.. A total of 120 patients were studied in 6 months were excluded 3, 60 were treated with Carbetocin, and 57 with Oxytocin. It was determined that there is a greater number of events of uterine atony (p = 0.007, with RR 11.06) and therefore greater need for additional tonic uterus (p = 0.027, with RR 5.44) in the group of Oxytocin. There was no statistically significant difference in the other variables.. Carbetocin is recommended as prophylaxis of obstetric hemorrhage in patients with risk factors for uterine atony.. Introducción: en México, en 2010, la hemorragia obstétrica ocupó el segundo lugar (19.6%) como causa directa de muerte materna. El objetivo de este trabajo es evaluar el efecto de la oxitocina y la carbetocina, en la prevención de hemorragia posparto en pacientes con factores de riesgo para atonía uterina. Métodos: estudio tipo ensayo clínico, se incluyeron a pacientes que presentaron al menos uno de los factores de riesgo para atonía uterina. De manera aleatoria, se dividieron en dos grupos: a uno se le administró oxitocina y el otro recibió carbetocina. Se determinaron las siguientes variables: factores de riesgo para atonía uterina, hemoglobina y hematocrito, signos vitales, sangrado transquirúrgico, si presentó o no atonía uterina, uresis, necesidad de uterotónicos adicionales y necesidad de transfusión de hemoderivados. Resultados: se estudiaron un total de120 pacientes en 6 meses, se excluyeron 3, de las cuales 60 fueron tratadas con carbetocina y 57 con oxitocina. Se determinó que existe un mayor número de eventos de atonía uterina (p = 0.007, con RR de 11.06) y, por ende, mayor necesidad de uterotónico adicional (p = 0.027, con RR de 5.44), en el grupo de la oxitocina. No hubo diferencia estadísticamente significativa en el resto de las variables. Conclusiones: Se recomienda carbetocina como profilaxis de hemorragia obstétrica en pacientes con factores de riesgo para atonía uterina.

Topics: Adult; Double-Blind Method; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Risk Factors; Treatment Outcome; Uterine Inertia

Postpartum hemorrhage (PPH) constitutes the main cause of delivery-related maternal mortality worldwide. Identification of the risk factors, as well as knowledge about preventive measures and adequate management, allow to limit blood loss. Oxytocin, carbetocin, methylergometrine, dinoprostone, suiprostone, and misoprostol are commonly used drugs in prevention of PPH.. The aim of the study was to evaluate the efficacy of carbetocin and oxytocin in prevention of PPH after cesarean section.. The study included 130 female patients after C-section who received 1 00 pg of carbetocin i.v. as a preventive agent after the surgery The control group consisted of 60 women who received 10 units of oxytocin i.v. In the study the risk factors for PPH were determined, and hemoglobin and hematocrit values before and 12 hours after birth, as well as blood loss and the need to use other prevyentfive and operational methods were evaluated. Results were compared between the groups. Statistical analysis was performed with the use of Statistica for hemoglobin and hematocrit values. The p-value of < or = 0.05 was considered as statistically significant.. Risk factors for PPH occurred in almost 100% of the women with carbetocin and in 90% of the women with oxytocin. The decrease in hemoglobin and hematocrit levels was not statistically significant, although a greater drop was detected in the group with oxytocin (hemoglobin - 1.24 vs. 1.17 g%, hematocrit - 3.26 vs. 2.93%). The decrease in hematological values was not statistically significant between both groups. In the group with'carbetocin, there was no need for additional pharmacological therapy or operative procedures. No adverse events in either of the groups were observed.. (1.) Carbetocin effectively prevents PPH after C-section. (2.) Carbetocin seems to have high efficiency in PPH prevention in pregnant women classified to the PPH risk group. (3.) Efficacy of Carbetocin in PPH prevention is higher than oxytocin.

Topics: Adult; Cesarean Section; Delayed-Action Preparations; Female; Humans; Injections, Intravenous; Oxytocics; Oxytocin; Postoperative Hemorrhage; Postpartum Hemorrhage; Pregnancy; Treatment Outcome; Young Adult

To compare combined sublingual misoprostol plus oxytocin infusion with intravenous carbetocin for prevention of postpartum hemorrhage (PPH) in patients with risk factors during cesarean section (CS).. In this randomized study, 380 patients were randomly allocated to receive either combined 400 μg sublingual misoprostol before surgery plus 20 IU oxytocin after delivery of baby (n = 190) or intravenous 100 μg carbetocin (n = 190). The main outcome measure was requirement of additional pharmacological uterotonic. Secondary outcomes were the difference in preoperative and postoperative hemoglobin, estimated blood loss, incidence of blood transfusion and adverse effects.. 16.3 % of women who received sublingual misoprostol plus oxytocin infusion required additional uterotonic versus 13.7 % of women who received intravenous carbetocin with no significant difference (p = 0.27). No significant difference between treatment groups in preoperative and postoperative hemoglobin level change, estimated blood loss, incidence of blood transfusion was observed. Shivering and fever were significantly higher with misoprostol plus oxytocin (p = <0.001 and <0.001, respectively).. Both sublingual misoprostol plus oxytocin infusion and intravenous carbetocin are similarly effective for the prevention of PPH in patients with risk factors during CS.

Topics: Administration, Sublingual; Adult; Cesarean Section; Delivery, Obstetric; Female; Humans; Infusions, Intravenous; Injections, Intramuscular; Injections, Intravenous; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Risk Factors; Treatment Outcome

The aim of this study was to determine the intravenous dose of carbetocin required to produce effective uterine contraction in 95% of women (ED95) undergoing elective Cesarean delivery under spinal anesthesia.. One hundred and twenty term pregnant women at low risk for postpartum hemorrhage (PPH) undergoing elective Cesarean delivery under spinal anesthesia were randomly allocated to receive carbetocin in doses of 20, 40, 60, 80, or 100 μg iv upon delivery of the fetus. The obstetrician evaluated the efficacy of uterine tone as satisfactory or unsatisfactory, and in case of unsatisfactory tone, additional uterotonics were administered as per routine institutional practice. The primary outcome measure was satisfactory uterine tone at two minutes after carbetocin administration, and the secondary outcomes were the estimated blood loss, need for additional uterotonic agents within 24 hr, and side effects.. Overall satisfactory uterine tone at two minutes was observed in 94.2% (113/120) of the women, and there was no difference across the different study groups. It was not possible to calculate the ED95 of carbetocin due to the even distribution of women with unsatisfactory uterine tone at two minutes across all dose groups (P = 0.60). Additional uterotonics within 24 hr were required in 13% (16/120) of the women. Side effects were similar across all dose groups, with an overall 42.5% incidence of hypotension following the administration of carbetocin.. In women at low risk for PPH undergoing elective Cesarean delivery under spinal anesthesia, carbetocin is similarly effective in doses of 20-100 μg. There is a high incidence of hypotension associated with carbetocin in these doses. Further dose-finding studies are warranted, including doses lower than 20 μg. This trial was registered at www.clinicaltrials.gov (NCT01428817).

Topics: Adult; Anesthesia, Spinal; Cesarean Section; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Hypotension; Incidence; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome; Uterine Contraction

To compare the effectiveness of carbetocin with oxytocin with respect to maintain adequate uterine tone and to reduce the incidence and severity of postpartum haemorrhage. Moreover safety, adverse effects and the need of additional medications were evaluated.. Prospective controlled clinical trial. We compared the effect of a single dose of carbetocin (n = 55) with oxytocin infusion (n = 55) in a women population undergoing to elective caesarean section with regional subarachnoid anaesthesia with at least one risk factor for postpartum haemorrhage.. The mean ± SD of postoperative pain in the day of surgery in carbetocin group was significantly lower than in oxytocin group and remained significant till the third day after caesarean section. In the day of surgery and the first day after surgery, women of carbetocin group who needed analgesic drugs were significantly lower than women of oxytocin group. The differences of diuresis and of diuretic drugs need were not statistically significant between the two groups.. A single carbetocin injection is efficacious and safe on the maintenance of uterine tone and on the limitation of blood losses, in peri- and in postoperative period. In addition, carbetocin was able to reduce pain perception during postoperative days improving quality life of women.

Topics: Adult; Cesarean Section; Down-Regulation; Drug Administration Schedule; Female; Humans; Infant, Newborn; Oxytocics; Oxytocin; Pain Perception; Pain, Postoperative; Postnatal Care; Postpartum Hemorrhage; Pregnancy; Risk; Treatment Outcome

To assess and compare the efficacy and safety of a single intramuscular dose of carbetocin to a single intramuscular dose of syntometrine in managing the third stage of labor following vaginal delivery among women with low risk factors for postpartum hemorrhage.. Prospective double-blind randomized controlled study.. The study included 240 healthy women with viable normal singleton pregnancies achieving normal vaginal delivery at or beyond 37 weeks' gestation during the period from May 2009 to December 2009 at TAIBA Hospital in Kuwait. Women were randomized to receive either a single dose of carbetocin or syntometrine intramuscularly following the delivery of the anterior shoulder of the baby. Outcome measures compared included postpartum hemorrhage requiring additional uterotonic therapy, incidence of postpartum hemorrhage, amount of intrapartum blood loss as well as adverse effects profile.. There was a statistically highly significant difference in the estimated mean blood loss between the carbetocin and syntometrine groups, with a blood loss of 81.5 ml higher in the syntometrine group. The mean drop of hemoglobin concentration 24 h after delivery was 0.8 g/dl in carbetocin group and 1.1 g/dl in syntometrine group, and the difference was statistically highly significant. Women in the carbetocin group were less likely to experience nausea and vomiting.. Single dose of intramuscular carbetocin 100 μg may be more effective as compared to a single intramuscular dose of syntometrine in reducing postpartum blood loss with a smaller drop in hemoglobin levels and less adverse effects.

Topics: Adult; Delivery, Obstetric; Double-Blind Method; Ergonovine; Female; Humans; Injections, Intramuscular; Labor Stage, Third; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Treatment Outcome; Young Adult

This study compares the maternal heart rate effects of carbetocin and oxytocin during elective caesarean delivery.. Double blind randomised single centre study (1:1).. University hospital providing intrapartum care.. Fifty-six women undergoing elective caesarean section after spinal anaesthesia.. Haemodynamic parameters were measured non-invasively using the Task Force(®) Monitor 3040i system. Measurements were taken for 500 seconds upon administration of a slow intravenous bolus of the clinically recommended doses of 100 μg of carbetocin or 5 IU of oxytocin to prevent postpartum haemorrhage (PPH).. Effect on maternal heart rate (HR).. Statistically indistinguishable haemodynamic effects were seen for both drugs, with a maximal effect at about 30-40 seconds: HR increased 17.98 ± 2.53 bpm for oxytocin and 14.20 ± 2.45 bpm for carbetocin. Systolic blood pressure (sBP) decreased (-26.80 ± 2.82 mmHg for oxytocin versus -22.98 ± 2.75 mmHg for carbetocin). Following the maximal effect, women treated with carbetocin recovered slowly to baseline values asymptotically (HR and BP), whereas women treated with oxytocin displayed a slight rebound bradycardia at 200 seconds (-6.8 ± 1.92 bpm). Patients under both treatments showed a similar profile of side effects without any indication of unexpected adverse effects.. Both oxytocins have comparable haemodynamic effects and are uterotonic drugs with an acceptable safety profile for prophylactic use. Minimal differences in the recovery phase beyond 70 seconds are in keeping with the fact that carbetocin has an extended half-life compared with oxytocin.

Topics: Adult; Cesarean Section; Double-Blind Method; Female; Hemodynamics; Humans; Injections, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Stimulation, Chemical; Time Factors; Uterine Contraction

in Mexico, obstetric hemorrhage and its complications are the second leading cause of maternal death and is the origin of irreversible functional consequences. Carbetocin is a synthetic analogue of oxytocin with an average lifespan four times that of oxytocin and pharmacological effects of 120 minutes produces a tonic contraction which reduces postpartum blood loss.. To evaluate the usefulness of carbetocin to prevent uterine bleeding complications and maternal deaths and assess the benefits, effectiveness and side effects.. Prospective, observational clinical research in two phases, the first from May 2005 to January 2006 with a sample of 40 patients and the second from January to December of 2008 with a sample of 72 patients conducted at the Hospital Materno Infantil Dr. Alberto López Hermosa, San Luis Potosi. All were high-risk pregnancies and medical complications that warranted specialty hospital management. The intervention consisted of applying undiluted single dose of 100 micrograms of intravenous carbetocin at the time of delivery, as prophylaxis in patients with uterine overdistention in the first phase of the study and complicated pregnancies in the second phase.. Were born by caesarean section over 60%. Initially, the hemoglobin showed a reduction of 17% after delivery. Seven patients required blood transfusion (17.5%). In the second phase, 65 patients (90%) did not require transfusion, only 6 patients (8%) required transfusion. No side effects were documented. Uterine overdistension was the main risk factor for bleeding and transfusion.. Carbetocin combines the safety of oxytocin and the strength of the ergonovine preparations. To determine where carbetocin will be situated in the future as an useful oxytocic, it requires more than a simple demonstration of its effectiveness. This should be determined in each clinical situation, with factors such as overdistended uterus, indicating the convenience and economic constraints.

Topics: Adult; Blood Loss, Surgical; Blood Transfusion; Cesarean Section; Contraception; Female; Humans; Hysterectomy; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy Complications; Pregnancy, High-Risk; Prospective Studies; Uterine Contraction; Uterine Hemorrhage; Young Adult

In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage, but the hemodynamic changes associated with severe preeclampsia make the management of any kind of bleeding particularly troublesome. There are many pharmacological options for the management of postpartum hemorrhage, oxytocin being the first line of treatment. There is as yet no evidence about the safety and efficacy of using carbetocin, an oxytocin agonist, in these patients. We aimed to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.. We performed a prospective double-blind randomized controlled trial in 60 women with severe preeclampsia, recruited between July and September 2010. The women were randomized to receive either oxytocin or carbetocin during the third stage of labour. The primary outcome measure was postpartum hemorrhage requiring additional uterotonics, and the secondary outcome measures were the difference in hemoglobin levels between groups, the development of oliguria, and hemodynamic status (mean arterial pressure and heart rate) after administration of the drug.. Carbetocin was as effective as oxytocin in the prevention of postpartum hemorrhage in women with severe preeclampsia. Carbetocin had a safety profile similar to that of oxytocin, and it was not associated with the development of oliguria or hypertension in this cohort.. Carbetocin is an appropriate alternative to oxytocin for the prevention of postpartum hemorrhage in women with severe preeclampsia. Considering that it appears not to have a major hemodynamic effect in women with severe preeclampsia and that it uses a lower volume per dose than oxytocin, it should be considered a valid option in the management of the third stage of labour in women with hypertensive disorders of pregnancy.

Topics: Double-Blind Method; Female; Humans; Oxytocics; Oxytocin; Placebos; Postpartum Hemorrhage; Pre-Eclampsia; Pregnancy; Prospective Studies

To compare the effectiveness of carbetocin and oxytocin when they are administered after caesarean section for prevention of postpartum haemorrhage (PPH).. Double-blind randomised single centre study (1:1 ratio).. Teaching hospital in Bristol, UK with 6000 deliveries per annum.. Women at term undergoing elective or emergency caesarean section under regional anaesthesia, excluding women with placenta praevia, multiple gestation and placental abruption.. Women were randomised to receive either carbetocin 100 microg or oxytocin 5 IU intravenously after the delivery of the baby. Perioperative care was otherwise normal and use of additional oxytocics was at the discretion of the operating obstetrician. Analysis was by intention to treat.. The proportion of women in each arm of the trial that needed additional pharmacological oxytocic interventions.. Significantly more women needed additional oxytocics in the oxytocin group (45.5% versus 33.5%, Relative risk 0.74, 95% CI 0.57-0.95). The majority of women had oxytocin infusions. There were no significant differences in the secondary outcomes, including major PPH, blood transfusions and fall in haemoglobin.. Carbetocin is associated with a reduced use of additional oxytocics. It is unclear whether this may reduce rates of PPH and blood transfusions.

Topics: Adolescent; Adult; Cesarean Section; Female; Humans; Injections, Intravenous; Oxytocics; Oxytocin; Parity; Postpartum Hemorrhage; Pregnancy; Risk Factors; Treatment Outcome; Young Adult

To compare the efficacy of a single dose of 100 microg intramuscular carbetocin to a single dose of intramuscular syntometrine (0.5 mg ergometrine and 5IU oxytocin), in preventing post-partum hemorrhage (PPH) in high risk patients following vaginal delivery.. A prospective, randomized controlled study was conducted in a tertiary hospital where 120 pregnant women with risk factors for PPH who delivered vaginally were randomized into two groups: the study group where 100 microg intramuscular carbetocin was administered and the control group, who received intramuscular syntometrine. Outcome measures compared included changes in vital signs, amount of intrapartum blood loss, uterine fundal position, addition of another oxytocic agent, side-effects of the drugs, amount of lochia and hemoglobin drop after 24 hours post-partum. Incidence of PPH or other adverse events were also compared.. There were no significant differences in terms of requirement for additional oxytocic agents, time interval to well contracted uterus, blood transfusion requirements, adverse effects or complications. There was a significantly lower mean estimated blood loss in the carbetocin group compared to the syntometrine group (244 +/- 114 mL vs 343 +/- 143 mL, 95% CI 52-146 mL). There was also a significantly reduced drop in hemoglobin in the carbetocin group compared to the syntometrine group (0.3 +/- 0.2 g/dL vs 0.4 +/- 0.2 g/dL, 95% CI 0.1-0.2 g/dL).. Intramuscular carbetocin may be more effective than intramuscular syntometrine in reducing post-partum blood loss and the drop in hemoglobin level.

Topics: Ergonovine; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies

A randomized study involving pregnant women was conducted to compare the effectiveness of a single intravenous (IV) injection of carbetocin with that of a standard 2-h oxytocin IV infusion with respect to intraoperative blood loss in the prevention of uterine atony after cesarean section (CS). The two treatments also were compared for safety and ability to maintain adequate uterine tone and to reduce the incidence and severity of postpartum hemorrhage (PPH) in women at risk for this condition.. Between 1 September 2007 and 5 January 2008, we enrolled 104 patients with at least one risk factor for PPH undergoing CS in a randomized, controlled clinical trial. We compared the effect of a single 100 microg IV dose of carbetocin with that of a standard 2-h ten international units (IU) IV infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. Fiftytwo women received 100 microg carbetocin IV immediately after placental delivery, while 52 women received 10 IU oxytocin IV infusion. Complete blood count was collected at entry and 24 h postpartum. All outcome measures, including the need for additional uterotonic agents or uterine massage, and blood loss, were analyzed using chi-square, Fisher exact, and Student's t tests.. A single 100 microg IV injection of carbetocin was as effective as a continuous 2-h infusion of oxytocin in controlling intraoperative blood loss after placental delivery. Mean blood loss after carbetocin administration was 30 ml less than after oxytocin administration (P = 0.5). The percentage of patients with blood loss < or =500 ml was greater with carbetocin (81 vs. 55%; P = 0.05). Carbetocin enhanced early postpartum uterine involution. The fundus was below the umbilicus in more patients who received carbetocin at 0, 2, 6, and 24 h on the ward (P < 0.05). The main additional uterotonic agent used was a further administration of oxytocin (20 IU in physiological solution 500 ml at an infusion rate of 200 ml/h). In the carbetocin group, 20 of the 52 women (38.4%) required at least one uterine massage compared to 30 of the 52 women (57.7%) in the oxytocin group (P < 0.01). Overall, uterotonic intervention was clinically indicated in two of the women (3.8%) receiving carbetocin compared to five of the women (9.6%) given an IV oxytocin infusion (P < 0.01). The odds ratio of treatment failure requiring oxytocic intervention was 1.83 (95% confidence interval, CI, 0.9-2.6) times higher in the oxytocin group compared with the carbetocin group.. Carbetocin makes possible to obtain, with a single IV injection, results equivalent to those of oxytocin on the maintenance of uterine tonicity and the limitation of blood losses, in the peri- and in the post-operative period, during a delivery by CS. It has in addition a comparable tolerance. Even in our series adverse events are practically of the same type and similar frequency in both study groups. Thus, the effectiveness of carbetocin consists, thanks to its long half-life, on an unique injection, whereas oxytocin requires repeated injections or a perfusion of several hours, with a variability of the administered doses.

Topics: Adult; Blood Cell Count; Cesarean Section; Double-Blind Method; Female; Humans; Injections, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Uterine Inertia; Young Adult

Prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. However, limited literature is available for comparing the use of oxytocin agonist carbetocin with syntometrine in women undergoing vaginal deliveries. We aimed to compare intramuscular carbetocin with intramuscular syntometrine for the routine prevention of postpartum haemorrhage in women who deliver vaginally.. Prospective double-blind randomised controlled trial.. Tertiary referral centre.. Pregnant women with no contraindication for vaginal delivery recruited from January 2005 to April 2008.. Participants were randomised to receive either syntometrine or carbetocin during the third stage of labour.. Primary outcome measure was postpartum haemorrhage requiring additional uterotonics. Secondary outcome measures were the incidence of postpartum haemorrhage (> or =500 ml), severe postpartum haemorrhage (> or =1000 ml) and adverse effects profile.. Women in the carbetocin group (13.5%) and in the syntometrine group (16.8%) had postpartum haemorrhage requiring additional uterotonics (P = 0.384). 1.6% of women in each group had postpartum haemorrhage (P = 1.0) and the estimated blood loss during the third stage of labour was similar between the two groups (P = 0.294). Women who had syntometrine were four times more likely to experience nausea (RR = 4.2; 95% CI 2.2-7.8) and vomiting (RR = 4.3; 95% CI 1.9-9.5) compared with women who had carbetocin. Tremor, sweating, retching and uterine pain were also more likely in the syntometrine group compared with the carbetocin group (P < 0.05).. Carbetocin has an efficacy similar to syntometrine for prevention of postpartum haemorrhage, but is associated with less adverse effects.

Topics: Adolescent; Adult; Double-Blind Method; Ergonovine; Female; Humans; Injections, Intramuscular; Labor Stage, Third; Middle Aged; Obstetric Labor Complications; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Treatment Outcome; Young Adult

Syntometrine is an effective uterotonic agent used in preventing primary postpartum haemorrhage but has adverse effects including nausea, vomiting, hypertension and coronary artery spasm. Carbetocin is a newly developed long-acting oxytocin analogue that might be used as an uterotonic agent. We compare the efficacy and safety of intramuscular (IM) carbetocin with IM syntometrine in preventing primary postpartum haemorrhage.. Prospective, double-blinded, randomised controlled trial.. Delivery suite of a university-based obstetrics unit.. Women with singleton pregnancy achieving vaginal delivery after and throughout 34 weeks.. Three hundred and twenty-nine eligible women were randomised to receive either a single dose of 100 microgram IM carbetocin or 1 ml IM syntometrine (a mixture of 5 iu oxytocin and 0.5 mg ergometrine) at the end of second stage of labour.. Difference in haemoglobin drop measured 2 days after delivery between the two groups.. There was no difference in the drop of haemoglobin concentration within the first 48 hours between the two groups. The incidence of additional oxytocic injections, postpartum haemorrhage (blood loss > or = 500 ml) and retained placenta were also similar. The use of carbetocin was associated with significant lower incidence of nausea (relative risk [RR] 0.18, 95% confidence interval [CI] 0.04-0.78), vomiting (RR 0.1, 95% CI 0.01-0.74), hypertension 30 minutes (0 versus 8 cases, P < 0.01) and 60 minutes (0 versus 6 cases, P < 0.05) after delivery but a higher incidence of maternal tachycardia (RR 1.68, 95% CI 1.03-3.57).. IM carbetocin is as effective as IM syntometrine in preventing primary postpartum haemorrhage after vaginal delivery. It is less likely to induce hypertension and has a low incidence of adverse effect. It should be considered as a good alternative to conventional uterotonic agents used in managing the third stage of labour.

Topics: Adult; Double-Blind Method; Ergonovine; Female; Humans; Labor Stage, Third; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Treatment Outcome

To compare the efficacy of a single 100 micro g intramuscular (IM) carbetocin injection, a long-acting oxytocin agonist, to a 2-hour 10 IU oxytocin intravenous (IV) infusion, in reducing the incidence and severity of postpartum hemorrhage (PPH) in women at risk for this condition.. A randomized, double-blind, placebo-controlled study was conducted at 2 hospital centres, including 160 women with at least 1 risk factor for PPH. Eighty-three women received 100 microg carbetocin IM and an IV placebo immediately after placental delivery, while 77 women received placebo IM and oxytocin IV infusion. Complete blood count was collected at entry and 24 hours postpartum. All outcome measures, including the need for additional uterotonic agents or uterine massage, blood loss, and drop in hemoglobin and hematocrit, were analyzed using chi-square, Fisher exact, and Student t tests.. Population profile and risk factors for PPH were similar for each group. No significant difference was observed in the number of women requiring additional uterotonic medication (12 in each group). However, in the carbetocin group, 36 of the 83 women (43.4%) required at least 1 uterine massage compared to 48 of the 77 women (62.3%) in the oxytocin group (P <.02). Overall, uterotonic intervention was clinically indicated in 37 of the women (44.6%) receiving carbetocin compared to 49 of the women (63.6%) given an IV oxytocin infusion (P <.02). There were no differences in laboratory PPH indicators between the 2 groups.

Topics: Delivery, Obstetric; Double-Blind Method; Female; Humans; Infusions, Intravenous; Injections, Intramuscular; Massage; Oxytocics; Oxytocin; Placebos; Postpartum Hemorrhage; Risk Factors; Uterus

The goal of this study was to compare carbetocin, a long-acting oxytocin analog, with oxytocin in the prevention of uterine atony after cesarean section.. We enrolled 694 patients undergoing elective cesarean section in a Canadian multicenter, double-blind, randomized clinical trial. We compared the effect of a single 100 microg dose of carbetocin with that of a standard 8-hour infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. A variable sample size, sequential design was used.. The overall oxytocic intervention rate was 7.4%. The odds of treatment failure requiring oxytocic intervention was 2.03 (95% confidence interval 1.1 to 2.8) times higher in the oxytocin group compared with the carbetocin group, respectively, 32 of 318 (10.1%) versus 15 of 317 (4.7%), P <.05.. Carbetocin, a new drug for the prevention of uterine atony, appears to be more effective than a continuous infusion of oxytocin and has a similar safety profile.

Topics: Adult; British Columbia; Cesarean Section; Double-Blind Method; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy Outcome; Uterine Contraction

To compare the effectiveness of prophylactic carbetocin with prophylactic oxytocin for preventing severe postpartum hemorrhage (PPH) following vaginal delivery.. This before and after cohort study took place between 2020 and 2021 in a university maternity hospital. In 2021, the protocol for PPH prevention immediately after vaginal delivery changed: intravenous oxytocin (5 IU) was replaced by intravenous carbetocin (100 μg). All patients with vaginal births were included, with two groups compared: patients who received prophylactic oxytocin in 2020 and those who received prophylactic carbetocin in 2021. The primary outcome was severe PPH, defined as one or more of the following: estimated blood loss ≥1500 mL, transfusion ≥4 units of red blood cells, Bakri balloon use, embolization, vascular ligation, hysterectomy, and maternal death.. Among 4832 women included, 2417 received oxytocin and 2415 received carbetocin. The rate of severe PPH was similar in both groups (0.5% vs. 0.6%, respectively; adjusted odds ratio, 0.8 [95% confidence interval, 0.4-1.8]). The rate of PPH ≥500 mL was lower in the carbetocin group (4% vs. 5.8%; P = 0.004).. Although prophylactic carbetocin was associated with a reduction in the rate of PPH ≥500 mL, carbetocin is no different to oxytocin in preventing severe PPH caused by atony after vaginal delivery.

Topics: Cohort Studies; Delivery, Obstetric; Female; Humans; Oxytocin; Postpartum Hemorrhage; Pregnancy

Low- and middle-income countries (LMICs) are committed to achieving the Sustainable Development Goal 3.1 to reduce maternal mortality. The Ministry of Health and Family Welfare of India recommends prophylactic uterotonic administration to every woman following delivery to reduce the risk of postpartum hemorrhage (PPH), as PPH is the leading cause of maternal mortality in LMICs, including India. In 2018, the World Health Organization first recognized heat-stable carbetocin for PPH prevention. Governments are now considering its introduction into their public health systems.. A decision-tree model was developed from the public healthcare system perspective to compare the value of heat-stable carbetocin versus oxytocin and misoprostol among women giving birth in public sector healthcare facilities in India. The model accounted for differences in PPH risk and costs based on mode of delivery and healthcare setting, as well as provider behavior to mitigate quality concerns of oxytocin. Model outcomes for each prophylactic uterotonic included the number of PPH events, DALYs due to PPH, deaths due to PPH, and direct medical care costs. The budget impact was estimated based on projected uterotonic uptake between 2022-2026.. Compared to oxytocin, heat-stable carbetocin avoided 5,468 additional PPH events, 5 deaths, and 244 DALYs per 100,000 births. Projected direct medical costs to the public healthcare system were lowered by US $171,700 (₹12.8 million; exchange rate of ₹74.65 = US$1 from 2 Feb 2022) per 100,000 births. Benefits were even greater when compared to misoprostol (7,032 fewer PPH events, 10 fewer deaths, 470 fewer DALYs, and $230,248 saved per 100,000 births). In the budget impact analysis, India's public health system is projected to save US$11.4 million (₹849 million) over the next five years if the market share for heat-stable carbetocin grows to 19% of prophylactic uterotonics administered.. Heat-stable carbetocin is expected to reduce the number of PPH events and deaths, avoid more DALYs, and reduce costs to the public healthcare system of India. Greater adoption of heat-stable carbetocin for the prevention of PPH could advance India's efforts to achieve its maternal health goals and increase efficiency of its public health spending.

Topics: Cost-Benefit Analysis; Female; Hot Temperature; Humans; India; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Carbetocin and oxytocin are commonly recommended agents for active management of the third stage of labour. Evidence is inconclusive whether either one more effectively reduces the occurrence of important postpartum haemorrhage outcomes at caesarean section. We examined whether carbetocin is associated with a lower risk of severe postpartum haemorrhage (blood loss ≥ 1000 ml) in comparison with oxytocin for the third stage of labour in women undergoing caesarean section. This was a retrospective cohort study among women undergoing scheduled or intrapartum caesarean section between 1 January 2010 and 2 July 2015 who received carbetocin or oxytocin for the third stage of labour. The primary outcome was severe postpartum haemorrhage. Secondary outcomes included blood transfusion, interventions, third stage complications and estimated blood loss. Outcomes were examined overall and by timing of birth, scheduled versus intrapartum, using propensity score-matched analysis. Among 21,027 eligible participants, 10,564 women who received carbetocin and 3836 women who received oxytocin at caesarean section were included in the analysis. Carbetocin was associated with a lower risk of severe postpartum haemorrhage overall (2.1% versus 3.3%; odds ratio, 0.62; 95% confidence interval 0.48 to 0.79;

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Uterine Inertia

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

To compare maternal outcomes using Carbetocin versus Oxytocin for the active management of the third stage of labor, given a temporary national shortage of Oxytocin.. We conducted a retrospective observational study on a cohort of 866 women with vaginal deliveries at our center, >36 weeks of gestation, between November 2018 and March 2019. During the shortage period, each woman received a single slow intravenous injection of Carbetocin 100 µg at delivery of the anterior shoulder, rather than Oxytocin 5 UI, as postpartum hemorrhage prophylaxis. 146 (16.9%) patients received Carbetocin versus 720 (83.1%) receiving Oxytocin. The outcomes were rates of postpartum hemorrhage, severe postpartum hemorrhage, and placental retention.. Incidence rates of placental retention and postpartum hemorrhage were 4.9% and 9.4% respectively. Placenta retention was significantly more likely following Carbetocin administration (adjusted odds ratio 2.5; 95% confidence interval 1.2-5.0). Postpartum hemorrhage rates were not significantly different (adjusted odds ratio 1.1; 95% confidence interval 0.6-2.1), as were severe postpartum hemorrhage rates (adjusted odds ratio 0.7; 95% confidence interval 0.2-2.2).. Carbetocin is as effective as Oxytocin for postpartum hemorrhage prevention. However, we would reserve it for use after placental delivery due to the increased retention rates.

Topics: Female; Humans; Oxytocics; Oxytocin; Placenta; Placenta, Retained; Postpartum Hemorrhage; Postpartum Period; Pregnancy

Recent World Health Organization (WHO) recommendations regarding uterotonics for the prevention of postpartum hemorrhage (PPH) state that carbetocin should be considered a first-line prophylactic agent for all births where its cost is comparable to other effective uterotonics. This study evaluated whether a room temperature stable formulation of carbetocin met this recommendation in a Canadian urban hospital setting.. A decision tree model was developed to assess the financial implications of replacing oxytocin with carbetocin as a first-line prophylactic agent for PPH prevention in a Greater Toronto Area (GTA) hospital. The analysis accounted for the mode of delivery, efficacies of carbetocin and oxytocin in PPH prevention, occurrence of PPH-related health outcomes, and health care resource costs for PPH interventions.. This study found that a GTA hospital, with 3242 deliveries per year, could save over CAD $349 000 annually by switching to room temperature stable carbetocin for PPH prevention. Carbetocin was able to lower institution costs by reducing the use of health care resources for PPH management in low-risk and high-risk PPH patients. The cost-saving potential of carbetocin relative to oxytocin was largely attributed to its greater efficacy in preventing the consequences of PPH.. The use of room temperature stable carbetocin as a first-line prophylactic agent for PPH prevention meets WHO recommendations regarding uterotonics for PPH in a GTA hospital. The model from this study can be used to determine the financial impact of switching from oxytocin to carbetocin in other jurisdictions while diversifying a hospital's pool of PPH prophylactic agents.

Topics: Canada; Costs and Cost Analysis; Female; Hospitals, Urban; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

A nationwide shortage of oxytocin in Canada resulted in a temporary switch from oxytocin to carbetocin for all postpartum women at our institution. This change offered a unique opportunity to conduct a pragmatic comparative assessment of the efficacy of carbetocin and oxytocin.. In a retrospective before-after study, we reviewed the medical records from 641 women in the carbetocin group and 752 women in the oxytocin group . The standard carbetocin dosing was 100 µg iv following vaginal and intrapartum Cesarean delivery, while for elective Cesarean delivery it was 50 µg, with an additional 50 µg if required. The standard oxytocin dosing was 5 IU iv followed by 2.4 IU·hr. The incidence of additional uterotonic use was not different between the carbetocin and oxytocin groups (12.0% vs 8.8%; P = 0.05; odds ratio, 1.39; 95% confidence interval, 0.97 to 2.00). The incidence of postpartum hemorrhage was higher in the carbetocin group than in the oxytocin group (10.3% vs 6.6%; P = 0.01). Blood transfusion was more common in the carbetocin group (1.4% vs 0.3%; P = 0.02).. There was no difference in the use of additional uterotonics when carbetocin or oxytocin were used in a cohort of women undergoing vaginal deliveries and both elective and emergency Cesarean deliveries.. RéSUMé: OBJECTIF: Une pénurie nationale d’ocytocine au Canada a entraîné l’utilisation temporaire de la carbétocine en remplacement de l’ocytocine pour toutes les femmes en post-partum dans notre établissement. Grâce à cette substitution, nous avons bénéficié d’une occasion unique de mener une évaluation comparative pragmatique de l’efficacité de la carbétocine et de l’ocytocine. MéTHODE: Dans une étude rétrospective avant-après, nous avons examiné les dossiers médicaux de 641 femmes dans le groupe carbétocine et de 752 femmes dans le groupe ocytocine. Le dosage standard de carbécotine était de 100 μg iv après un accouchement vaginal et pendant un accouchement par césarienne intrapartum, tandis que pour un accouchement par césarienne élective, le dosage était de 50 μg, avec 50 μg supplémentaires au besoin. Le dosage standard d’ocytocine était de 5 UI iv suivi de 2,4 UI·h

Topics: Controlled Before-After Studies; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies

Prevention of postpartum haemorrhage has been a major issue for its life threatening impact on maternal morbidity and mortality worldwide. Conventional continuous infusion of oxytocin has been employed for this condition. Apparently, in place of conventional oxytocics, application of carbetocin with longer half-life shows the same clinical benefits. This requires doing this present study. To compare the effectiveness of I/V bolus cabetocin and oxytocin infusion used for prevention of primary PPH after caesarean section. This descriptive cross-sectional comparative study was carried out in Department of Obstetrics and Gynaecology, Mymensingh Medical College Hospital (MMCH), Mymensingh, Bangladesh from November 2015 to April 2016. A total of 100 pregnant women undergoing elective or emergency caesarean section were enrolled and divided into two groups on the basis of exclusion and inclusion criteria. Group I (n=50) received bolus of 100μgm IV carbetocin after delivery of the baby & Group II (n=50) received 20 IU of oxytocin in 1000ml of Hartman solution I/V in 8 hours continuous infusion after delivery of the baby. Baseline demographic and obstetric profile, indications for C/S, estimated blood loss, hemoglobin level, additional uterotonic agents, blood pressure and the diuresis were compared immediate postoperatively and 24 hours after operation. The patients were followed up for 24 hours after operation regarding outcomes variables. Baseline profiles were similar between two groups. Regarding haemodynamic effects, both drugs have a hypotensive effect but a greater reduction in blood pressure is found in oxytocin group. There was no significant difference in respect of estimated blood loss, blood transfusion, additional oxytocics and diuresis between two groups. It can be concluded that a single injection of carbetocin is as effective as continuous oxytocin infusion to prevent postpartum haemorrhage, with similar haemodynamic profile. So, carbetocin as a uterotonic agent is an acceptable alternative for prevention of postpartum haemorhage after caesarean section.

Topics: Bangladesh; Cesarean Section; Cross-Sectional Studies; Female; Hospitals; Humans; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Female; Hot Temperature; Humans; Oxytocin; Postpartum Hemorrhage; Pregnancy; Tranexamic Acid

Postpartum hemorrhage (PPH) is a major cause of maternal morbidity, and oxytocin is the first-line uterotonic agent for PPH prevention. Clinical findings have reported carbetocin to reduce PPH risk without increasing risk of important side effects. Hong Kong is a low PPH burden and high-resource city in China. We aimed to examine the cost-effectiveness of PPH prevention with carbetocin from the perspective of Hong Kong public healthcare provider.. A decision-analytic model was developed to simulate clinical and economic outcomes of carbetocin and oxytocin for PPH prevention in a hypothetical cohort of women at the third stage of labor following vaginal birth or Caesarean section (C-section). The model inputs were retrieved from literature and public data. Base-case analysis and sensitivity analysis were performed. The model time horizon was the postpartum hospitalization period. Primary model outcomes included PPH-related direct medical cost, PPH, hysterectomy, maternal death, and quality-adjusted life-year (QALY) loss.. In base-case analysis, carbetocin (versus oxytocin) reduced PPH-related cost (by USD29 per birth), PPH ≥500 mL and ≥1,500 mL (by 13.7 and 1.9 per 1,000 births), hysterectomy (by 0.15 per 1,000 births), maternal death (by 0.02 per 1,000 births), and saved 0.00059 QALY per birth. Relative risk of PPH ≥500 mL with carbetocin versus oxytocin, and proportion of child births by C-section were two influential parameters identified in deterministic sensitivity analysis. In probabilistic sensitivity analysis, carbetocin was accepted as cost-effective in >99.7% of the 10,000 Monte Carlo simulations at a willingness-to-pay threshold of zero USD/QALY.. PPH prevention with carbetocin appeared to reduce major unfavorable outcomes, and save cost and QALYs.

Topics: Cesarean Section; Child; Cost-Effectiveness Analysis; Female; Humans; Maternal Death; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Ergonovine; Female; Humans; Infant, Newborn; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Quality of Life

Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care.. The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries.. Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014-004445-26. Date of registration 14 August 2014 Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding.

Topics: Adult; Female; Health Care Costs; Health Services Accessibility; Hospitals; Humans; Kenya; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Uganda

Twin pregnancy has a high risk for developing uterine atony (UA). This study aimed to evaluate efficacy and clinical outcomes of prophylactic compression sutures to treat UA during twin cesarean section (CS).. All patient records of twin deliveries by CS after gestational age of 24 weeks in a large maternity hospital in South Korea between January 2013 and June 2018 were reviewed. Patients with monochorionic monoamniotic twins were excluded from data analysis. In total, 953 women were eligible for data analysis.. Of the 953 patients, compression sutures were applied to 147 cases with postpartum bleeding that were refractory to uterine massage and uterotonics. Out of the 147, two patients (1.4%) proceeded to additional uterine artery ligation to achieve hemostasis, yielding a success rate of 98.6%. The rate of transfusion after the first 24 h of delivery in the suture group was not significantly different from that in the non-suture group, suggesting that both groups achieved hemostasis at an equal rate after the first 24 h of delivery. The difference in the operation time between the two groups was only 8.5 min. The rate of subsequent pregnancy among the patients who received compression sutures was 44.4%.. Overall, our findings suggest that with early and fast implementation of compression sutures, UA can be treated in the setting of twin cesarean delivery without significantly increasing maternal morbidity.

Topics: Adult; Blood Transfusion; Cesarean Section; Dinoprostone; Female; Hemostasis, Surgical; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy, Twin; Suture Techniques; Treatment Outcome; Uterine Artery Embolization; Uterine Inertia

Postpartum haemorrhage is a major cause of maternal mortality and morbidity, commonly due to uterine atony. Prophylactic oxytocin use during Caesarean section is recommended; patients with a high risk of postpartum haemorrhage may require additional uterotonics or procedures. Carbetocin is a long-acting analogue of oxytocin which has shown beneficial results, compared with oxytocin. This study compared the requirement for additional uterotonics or procedures between at-risk women who underwent carbetocin infusion and those who underwent oxytocin infusion.. This retrospective cohort study included women at increased risk of postpartum haemorrhage after Caesarean section for various indications in a public hospital. Women who received carbetocin infusion and women who received oxytocin infusion were compared, stratified by Caesarean section timing (elective or emergency). The primary outcome was the requirement for additional uterotonic agents or procedures. Secondary outcomes included total blood loss, operating time, rate of postpartum haemorrhage, need for blood transfusion, and need for hysterectomy.. Of 1236 women included in the study, 752 received oxytocin first and 484 received carbetocin first. The two groups had comparable blood loss, operating time, rate of postpartum haemorrhage, requirement for additional uterotonics or procedures, need for blood transfusion, and need for hysterectomy. There was a reduction in the requirement for additional uterotonics or procedures, and in the rate of postpartum haemorrhage for women with major placenta praevia or with multiple pregnancies, following receipt of carbetocin first.. Compared with oxytocin, carbetocin can reduce the requirement for additional uterotonics or procedures in selected high-risk patient groups.

Topics: Adult; Blood Transfusion; Cesarean Section; Female; Humans; Hysterectomy; Infusions, Intravenous; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Treatment Outcome

Topics: Cesarean Section; Female; Humans; Oxytocin; Postpartum Hemorrhage; Pregnancy; Women

The World Health Organization (WHO) recommends oxytocin as the drug of choice for postpartum hemorrhage (PPH) prevention. However, the WHO has also recently considered carbetocin for PPH prevention, but only if carbetocin were a cost-effective choice in the country. Consequently, we determined the cost-effectiveness and budgetary impact of carbetocin against oxytocin in the Philippines.. A cost-utility analysis using a decision tree was done to compare the costs and outcomes of carbetocin with oxytocin for PPH prophylaxis among women undergoing either vaginal delivery (VD) or cesarean section (CS) in a six-week time horizon using a societal perspective. One-way and probabilistic sensitivity analyses were applied to investigate parameter uncertainties. Additionally, budget impact analysis was conducted using a governmental perspective. Results were presented as incremental cost-effectiveness ratio (ICER) using a 2895 United States dollar (USD) per quality adjusted life year (QALY) gained as the ceiling threshold in the Philippines.. Carbetocin was not cost-effective given the listed price of carbetocin at 18 USD. Given a societal perspective, the ICER values of 13,187 USD and over 40,000 USD per QALY gained were derived for CS and VD, respectively. Moreover, the ICER values were sensitive to the risk ratio of carbetocin versus oxytocin and carbetocin price. On budget impact, the five-year total budget impact of a drug mix of carbetocin and oxytocin was 25.54 million USD (4.23 million USD for CS and 21.31 million USD for VD) compared with 'only oxytocin' scenario.. Carbetocin is not a cost-effective choice in PPH prevention for both modes of delivery in the Philippines, unless price reduction is made. Our findings can be used for evidence-informed policies to guide coverage decisions on carbetocin not only in the Philippines but also in other low and middle-income countries.

Topics: Cesarean Section; Cost-Benefit Analysis; Female; Humans; Oxytocics; Oxytocin; Philippines; Postpartum Hemorrhage; Pregnancy

The objective of this study was to determine the pattern of uterotonic drug usage in obstetric units of university-affiliated hospitals in Canada.. This was a prospective observational study conducted in the form of an electronic survey. The target group consisted of chiefs or directors of Obstetrics and Anaesthesia at university-affiliated hospitals across Canada. The survey was sent out between November 2016 and January 2017, using the program 'SurveyMonkey'. Data on institutional obstetric practices and usage of uterotonic agents were collected.. The survey was sent to 92 obstetricians and anesthesiologists from 46 institutions, of which 33 clinicians from 24 institutions responded. About 65% of clinicians were unaware of the rate of postpartum hemorrhage in their institution. The first-line agent for vaginal deliveries was reported as oxytocin by 94% and carbetocin by 6% of physicians. For women at low-risk for postpartum hemorrhage when undergoing cesarean deliveries (CD), 66% reported oxytocin as the first-line uterotonic, while 34% reported carbetocin. For CDs at high-risk of postpartum hemorrhage, 60% of physicians reported oxytocin and 40% reported using carbetocin initially. The use of second-line uterotonics was also variable. The choice of uterotonic was mainly based on perceived efficacy and Society of Obstetricians and Gynaecologists of Canada guidelines.. There is a lack of a unified approach to the use of uterotonic drugs for postpartum hemorrhage management in Canada. To improve the management of postpartum hemorrhage due to uterine atony, an evidence-based approach to usage and consensus between obstetricians and anesthesiologists is warranted.

Topics: Canada; Cesarean Section; Female; Hospitals, University; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies

The long-acting oxytocic agent; carbetocin, has been consistently shown to reduce the need for additional uterotonics at caesarean section, but not postpartum haemorrhage (PPH). While promising, current evidence is limited by heterogenicity in study design and findings.. To examine whether carbetocin confers clinical or economic benefit compared to oxytocin at caesarean section in an all-risk Australian population.. A retrospective cohort study was undertaken of all singleton caesarean sections at a public tertiary hospital from 2008 to 2010 (n = 2499). From 1 January 2008 to 24 March 2009 all women received prophylactic oxytocin 5-10 units slow push intravenously at delivery, after which all patients received 100 μg intravenous carbetocin. Outcomes were PPH (≥1000 mL) and the requirement of secondary uterotonics. A post hoc cost analysis was also performed.. A total of 1467 and 1024 patients received carbetocin and oxytocin, respectively. Incidence of PPH ≥1000 mL was 7.8% for carbetocin compared to and 9.7% for oxytocin (odds ratio (OR) 0.79, 95% CI 0.59-1.05). Moderate blood loss >500 mL was significantly reduced with carbetocin; occurring in 27.3% versus 39.4% (OR 0.57, 95% CI 0.49-0.68). There was a 20.0% reduction in secondary uterotonic treatment with carbetocin (OR 0.42, 95% CI 0.35-0.49). Average drug costs were lower with oxytocin at $4.74 versus $36.42/patient. However, the 1.9% reduction in PPH with carbetocin resulted in a $63.46 reduction in cost per patient, with a cost-effectiveness ratio of $1667 to prevent one case of PPH ≥1000 mL.. Carbetocin reduced moderate blood loss >500 mL, but not PPH ≥1000 mL. Carbetocin conferred a 20% reduction in secondary uterotonic treatment, as well as lowering direct medical costs.

Topics: Adult; Australia; Cesarean Section; Cost-Benefit Analysis; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Young Adult

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic drugs can reduce blood loss and are routinely recommended. There are several uterotonic drugs for preventing PPH, but it is still debatable which drug or combination of drugs is the most effective.. To identify the most effective and cost-effective uterotonic drug(s) to prevent PPH, and generate a ranking according to their effectiveness and side-effect profile.. The Cochrane Pregnancy and Childbirth's Trials Register (1 June 2015), ClinicalTrials.gov and the World Health Organization (WHO)'s International Clinical Trials Registry Platform (ICTRP) were searched for unpublished trial reports (30 June 2015). In addition, reference lists of retrieved studies (updated October 2017) were searched for randomised trials evaluating uterotonic drugs for preventing PPH. The study estimated relative effects and rankings for preventing PPH, defined as blood loss of ≥ 500 ml and ≥ 1000 ml. Pairwise meta-analyses and network meta-analysis were performed to determine the relative effects and rankings of all available drugs and combinations thereof [ergometrine, misoprostol (Cytotec. From 137 randomised trials and 87,466 women, ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin were found to reduce the risk of PPH blood loss of ≥ 500 ml compared with the standard drug, oxytocin [ergometrine plus oxytocin: risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.83; carbetocin: RR 0.72, 95% CI 0.52 to 1.00; misoprostol plus oxytocin: RR 0.73, 95% CI 0.6 to 0.9]. Each of these three strategies had 100% cumulative probability of being ranked first, second or third most effective. Oxytocin was ranked fourth, with an almost 0% cumulative probability of being ranked in the top three. Similar rankings were noted for the reduction of PPH blood loss of ≥ 1000 ml (ergometrine plus oxytocin: RR 0.77, 95% CI 0.61 to 0.95; carbetocin: RR 0.70, 95% CI 0.38 to 1.28; misoprostol plus oxytocin: RR 0.90, 95% CI 0.72 to 1.14), and most secondary outcomes. Ergometrine plus oxytocin and misoprostol plus oxytocin had the poorest ranking for side effects. Carbetocin had a favourable side-effect profile, which was similar to oxytocin. However, the analysis was restricted to high-quality studies, carbetocin lost its ranking and was comparable to oxytocin. The relative cost-effectiveness of the alternative strategies is inconclusive, and the results are affected by both the uncertainty and inconsistency in the data reported on adverse events. For vaginal delivery, when assuming no adverse events, ergometrine plus oxytocin is less costly and more effective than all strategies except carbetocin. The strategy of carbetocin is both more effective and more costly than all other strategies. When taking adverse events into consideration, all prevention strategies, except oxytocin, are more costly and less effective than carbetocin. For delivery by caesarean section, with and without adverse events, the relative cost-effectiveness is different, again because of the uncertainty in the available data.. There was considerable uncertainty in findings within the planned subgroup analyses, and subgroup effects cannot be ruled out.. Ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin are more effective uterotonic drug strategies for preventing PPH than the current standard, oxytocin. Ergometrine plus oxytocin and misoprostol plus oxytocin cause significant side effects. Carbetocin has a favourable side-effect profile, which was similar to oxytocin. However, most carbetocin trials are small and of poor quality. There is a need for a large high-quality trial comparing carbetocin with oxytocin; such a trial is currently being conducted by the WHO. The relative cost-effectiveness is inconclusive, and results are affected by uncertainty and inconsistency in adverse events data.. This study is registered as PROSPERO CRD42015020005; Cochrane Pregnancy and Childbirth Group (substudy) reference number 0871; PROSPERO-Cochrane (substudy) reference number CRD42015026568; and sponsor reference number ERN_13-1414 (University of Birmingham, Birmingham, UK).. Funding for this study was provided by the National Institute for Health Research Health Technology Assessment programme in a research award to the University of Birmingham and supported by the UK charity Ammalife (UK-registered charity 1120236). The funders of the study had no role in study design, data collection, data synthesis, interpretation or writing of the report.. Postpartum haemorrhage (PPH) is the most common reason why mothers die in childbirth worldwide. Although most healthy women can cope well with blood loss after birth, some do not, and this can pose a serious risk to their health and even life. To reduce blood loss after birth, the routine administration of a drug to contract the uterus (uterotonic) has become standard practice across the world. This research seeks to identify which is the most effective and cost-effective drug. Different drugs have been used for reducing the occurrence of PPH. They include oxytocin, misoprostol, ergometrine, carbetocin, and combinations of these drugs, each with different effectiveness and side effects. The study synthesised the available evidence to compare all of these drugs and combinations thereof. After putting the results of all available comparisons together in a network, a ranking among them was calculated, and provided robust effectiveness and side-effect profiles for each drug and their associated costs. The study included 137 randomised trials, involving a total of 87,466 women. The results suggested that ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin are the most effective strategies for preventing PPH and are more effective than the currently recommended drug, oxytocin. Each of these three strategies had almost 100% probability of being ranked first, second or third most effective. Oxytocin was ranked fourth with an almost 0% probability of being ranked in the top three. Ergometrine plus oxytocin and misoprostol plus oxytocin were the worst drug combinations for side effects, with carbetocin having the most favourable side-effect profile. Carbetocin could prevent approximately one further event of PPH out of three in comparison with oxytocin. However, existing carbetocin studies were small and of poor quality. There is need for a large high-quality study comparing carbetocin with the current standard treatment of oxytocin for the prevention of PPH. The cost analyses of the alternative drug strategies remain inconclusive.

Topics: Clinical Trials as Topic; Delivery, Obstetric; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Ergonovine; Female; Humans; Misoprostol; Network Meta-Analysis; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Adult; Cesarean Section; Clinical Protocols; Female; Humans; Incidence; Injections, Intravenous; Length of Stay; Oxytocics; Oxytocin; Patient Satisfaction; Postpartum Hemorrhage; Pregnancy; Prospective Studies

To evaluate the cost effectiveness of carbetocin compared to oxytocin when used as prophylaxis against post-partum hemorrhage (PPH) during cesarean deliveries.. A systematic review of the literature was performed to identify randomized controlled trials that compared the use of carbetocin to oxytocin in the context of cesarean deliveries. Cost effectiveness analysis was then performed using secondary data from the perspective of a maternity unit within the Malaysian Ministry of Health, over a 24 h time period.. Seven randomized controlled trials with over 2000 patients comparing carbetocin with oxytocin during cesarean section were identified. The use of carbetocin in our center, which has an average of 3000 cesarean deliveries annually, would have prevented 108 episodes of PPH, 104 episodes of transfusion and reduced the need for additional uterotonics in 455 patients. The incremental cost effectiveness ratio of carbetocin for averting an episode of PPH was US$278.70.. Reduction in retreatment, staffing requirements, transfusion and potential medication errors mitigates the higher index cost of carbetocin. From a pharmacoeconomic perspective, in the context of cesarean section, carbetocin was cost effective as prophylaxis against PPH. Ultimately, the relative value placed on the outcomes above and the individual unit's resources would influence the choice of uterotonic.

Topics: Adolescent; Adult; Cesarean Section; Cost-Benefit Analysis; Female; Hospitals, High-Volume; Hospitals, Maternity; Humans; Outcome and Process Assessment, Health Care; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Young Adult

Postpartum hemorrhage is one of the main causes of maternal death. Oxytocin has traditionally been used to prevent postpartum hemorrhage.. To compare oxytocin with carbetocin, a long-acting analog of oxytocin, for prevention of uterine hemorrhage after cesarean delivery.. Clinical data were retrieved from the 2012 Cochrane meta-analysis "Carbetocin for preventing postpartum hemorrhage". A decision tree was constructed. The direct costs were those of medications from the Peruvian official price list (DIGEMID). Costs associated with additional oxytocic drugs, blood transfusions, postpartum hemorrhage kits and hysterectomy were obtained from Hospital Nacional Edgardo Rebagliati Martins. The perspective of the study was that of the payer. The time horizon for calculating quality-adjusted life years (QALYs) was 1 year (2015).. Patients who received carbetocin required fewer additional uterotonic agents, had fewer hemorrhages and received fewer blood transfusions. Therefore, the costs associated with these interventions were lower. The incremental cost-effectiveness ratio was S/. 49,918 per QALY gained, which is lower than the threshold we estimated for Peru.. Carbetocin is more cost-effective than oxytocin for prevention of uterine hemorrhage after cesarean delivery.

Topics: Cesarean Section; Cost-Benefit Analysis; Economics, Pharmaceutical; Female; Humans; Oxytocics; Oxytocin; Peru; Postpartum Hemorrhage

Postpartum haemorrhage is a leading cause of maternal death worldwide. Oxytocin, currently the drug of choice for prevention of PPH, requires constant refrigeration. In pursuit of an alternative medicine, Ferring Pharmaceuticals have developed a heat-stable formulation of carbetocin, an oxytocin analogue. This study aimed to define that formulation, and to investigate its stability under ICH climate zone IV conditions (30°C/75% relative humidity) for at least 3 years and at extreme temperatures, such as 60°C, for shorter periods of time. The development resulted in a heat-stable carbetocin formulation consisting of 0.1 mg/mL carbetocin in sodium succinate buffer, mannitol, and methionine. The optimum pH was determined to be pH 5.45 (5.25-5.65). The generated stability data of this formulation show that ≥95% purity of the peptide was maintained for a minimum of 3 years at 30°C, 6 months at 40°C, 3 months at 50°C and 1 month at 60°C. In addition, the heat-stable carbetocin formulation was not sensitive to freezing or light. The reported highly stable peptide formulation facilitates the distribution in low and middle-income countries, where maintaining cold chain distribution is difficult. Ferring Pharmaceuticals, the World Health Organization, and MSD for Mothers have established a collaboration to develop this heat-stable formulation of carbetocin for the prevention of post-partum hemorrhage in women after vaginal childbirth, with the aim of making the medicine available in the public sector of developing countries that have a high burden of maternal mortality.

Topics: Adult; Drug Compounding; Drug Storage; Female; Hot Temperature; Humans; Hydrogen-Ion Concentration; Oxytocin; Postpartum Hemorrhage; Pregnancy

 To assess the cost-effectiveness of carbetocin versus oxytocin for prevention of postpartum hemorrhage (PPH) due to uterine atony after vaginal delivery/cesarean section in women with risk factors for bleeding..  A decision tree was developed for vaginal delivery and another one for cesarean, in which a sequential analysis of the results was obtained with the use of carbetocin and oxytocin for prevention of PPH and related consequences. A third-party payer perspective was used; only direct medical costs were considered. Incremental costs and effectiveness in terms of quality-adjusted life years (QALYs) were evaluated for a one-year time horizon. The costs were expressed in 2016 Colombian pesos (1 USD = 3,051 Col$)..  In the vaginal delivery model, the average cost of care for a patient receiving prophylaxis with uterotonic agents was Col$ 347,750 with carbetocin and Col$ 262,491 with oxytocin, while the QALYs were 0.9980 and 0.9979, respectively. The incremental cost-effectiveness ratio is above the cost-effectiveness threshold adopted by Colombia. In the model developed for cesarean section, the average cost of a patient receiving prophylaxis with uterotonics was Col$ 461,750 with carbetocin, and Col$ 481,866 with oxytocin, and the QALYs were 0.9959 and 0.9926, respectively. Carbetocin has lower cost and is more effective, with a saving of Col$ 94,887 per avoided hemorrhagic event..  In case of elective cesarean delivery, carbetocin is a dominant alternative in the prevention of PPH compared with oxytocin; however, it presents higher costs than oxytocin, with similar effectiveness, in cases of vaginal delivery..  Avaliar a relação custo-eficácia da carbetocina versus oxitocina para prevenção de hemorragia pós-parto (HPP) vaginal e cesariana devido à atonia uterina em mulheres com fatores de risco para desenvolver sangramento. MéTODOS:  Foram desenvolvidos protocolos de manejo para parto vaginal e outra para parto por cesárea e analisados resultados obtidos com carbetocina e oxitocina na prevenção de HPP, assim como, consequências relacionadas à ocorrência do evento hemorrágico. A perspectiva utilizada foi a do terceiro pagador, portanto, apenas os custos médicos diretos foram levados em consideração. Os custos incrementais e a eficácia em termos de anos de vida ajustados pela qualidade (QALY) foram avaliados para um horizonte de tempo de um ano. Os custos foram expressos em pesos colombianos de 2016 (1 USD = 3.051 Col$)..  No modelo de parto vaginal, o custo médio de cuidados para um paciente que recebeu profilaxia com agentes uterotônicos foi de Col$ 347.750 com carbetocina e Col$ 262.491 com oxitocina, enquanto os QALYs foram 0,9980 e 0,9979, respectivamente. O índice incremental de custo-efetividade está acima do limite de custo-efetividade adotado pela Colômbia. No modelo desenvolvido para parto por cesárea, o custo médio do paciente que recebeu profilaxia com terapia uterotônica foi de Col$ 461.750 com carbetocina e Col$ 481.866 com oxitocina e os QALYs foram 0,9959 e 0,9926, respectivamente. A carbetocina foi a alternativa com menor custo e maior efetividade com uma economia de $94.887 por evento hemorrágico evitado. CONCLUSãO:  A carbetocina no parto eletivo por cesárea é uma alternativa dominante na prevenção da PPH em relação à oxitocina; porém representa custos mais altos com uma eficácia similar à da oxitocina no caso de parto vaginal.

Topics: Colombia; Cost-Benefit Analysis; Decision Support Techniques; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Risk Assessment; Uterine Inertia

Topics: Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage

Topics: Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage

To compare the efficacy of carbetocin and oxytocin on hemorrhage-related changes in women with cesarean deliveries (CS) for different indications.. A retrospective cohort study was conducted on 1568 women with CS before labor onset (elective CS, n = 1153) or during labor (intrapartum CS, n = 415) after 24 weeks' gestation. We compared the fall in hemoglobin (Hb) and hematocrit (Hct) levels after CS, estimated blood loss, the need for additional uterotonic agents, blood transfusion, and the rate of postpartum hemorrhage between women with carbetocin and women with oxytocin treatment, stratified by indications for CS.. For women with elective CS, decreased Hb and Hct falls were noted with carbetocin treatment compared to oxytocin treatment in women with indications for prior CS, fetal malpresentation, and multiple gestation. The need for additional uterotonics was less in CS for prior CS, fetal malpresentation, and cephalopelvic disproportion and fewer transfusions in CS for multiple gestation in women with carbetocin compared to women with oxytocin treatment. For women with intrapartum CS, carbetocin was associated with decreased use of additional uterotonic agents and transfusion in CS for dysfunctional labor.. Carbetocin and oxytocin had differential effects on hemorrhage-related changes in women with CS for different indications.

Topics: Adult; Blood Transfusion; Cesarean Section; Cohort Studies; Female; Gestational Age; Hematocrit; Hemoglobins; Humans; Labor Presentation; Labor, Obstetric; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy, Multiple; Retrospective Studies

Topics: Female; Hot Temperature; Humans; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Female; Hot Temperature; Humans; Oxytocin; Parturition; Postpartum Hemorrhage; Pregnancy

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylaxis with oxytocic medication is recommended by the WHO to prevent its occurrence. Carbetocin is a newer oxytocic, with potential to lower PPH rates, reduce the total use of oxytocic drugs and lead to financial savings. Meta-analyses have confirmed a reduction in the use of additional oxytocic medication with the use of carbetocin compared to oxytocin. However, there are few studies evaluating the costs of carbetocin prophylaxis. We carried out a prospective cohort study evaluating the financial impact of carbetocin, following its introduction at our centre for caesarean section. We collected data for 400 patients in total, making this, to our knowledge, the largest study conducted on this topic. We found a significant reduction in PPH rates and the use of additional oxytocics with projected overall financial savings of £68.93 per patient with the use of carbetocin. Impact statement It is well established that carbetocin reduces the use of secondary oxytocics compared to oxytocin alone in the active management of the third stage of labour. Evidence for reduction of post-partum haemorrhage and its cost effectiveness are more equivocal. Our study demonstrates that carbetocin also reduces post-partum haemorrhage, use of blood and blood products and midwifery recovery time in the setting of caesarean section. We have also demonstrated that despite the increased index cost of carbetocin it delivers an overall substantial cost benefit. The implications of these findings are of reduced morbidity, faster recovery and cost savings in these times of austerity in the UK. It allows more efficient labour distribution of midwives, particularly in the setting of staff shortages across the NHS. A randomised control trial in this area needs to be conducted to determine the cost benefit of carbetocin and with this and post-partum haemorrhage rates as the primary outcome measures.

Topics: Cesarean Section; Cost-Benefit Analysis; Female; Humans; Oxytocics; Oxytocin; Postoperative Complications; Postpartum Hemorrhage; Pregnancy; Prospective Studies

To compare the efficacy and safety of carbetocin with those of oxytocin infusion in women with twin pregnancy undergoing elective cesarean delivery.. The present observational study conducted from January to December 2014 at a single center in Taiwan enrolled 64 women with twin pregnancy induced using in vitro fertilization-embryo transfer. The women were divided into a carbetocin group who received a single injection of 100 μg carbetocin (n = 25) and a control group who received a continuous intravenous infusion of 10 IU oxytocin in 500 mL 0.9% NaCl solution (125 mL/h) for 24 h (n = 39). Operative outcomes were compared between the groups.. The mean estimated blood loss during surgery was lower in the carbetocin group compared with the control group (871 ± 305 and 922.8 ± 430 mL, respectively), but the difference was not significant (P = 0.06). There was also no significant difference in the drop in hemoglobin level between two groups. The mean operative time was significantly shorter in the carbetocin group compared with the control group (P = 0.001).. Carbetocin is as effective as oxytocin in preventing primary postpartum hemorrhage in infertile women with twin pregnancy undergoing elective cesarean delivery.

Topics: Adult; Cesarean Section; Elective Surgical Procedures; Female; Humans; Infertility, Female; Injections, Intravenous; Operative Time; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy, Twin; Risk Factors

Topics: Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Topics: Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

To compare the cost of carbetocin with that of oxytocin for the prevention and management of hemorrhage following cesarean delivery in Ecuador.. We developed a decision tree based cost-effectiveness model to compare carbetocin with oxytocin in the prevention of hemorrhage following cesarean delivery in Ecuador. Our model was run from a third party payer perspective and was validated by local experts in the field. The efficacy of the interventions was determined based on a systematic review of the literature. Direct costs were calculated based on current National Health Service price lists and retail price. Since the period covered by the analysis was 1 year, costs and health effects were not discounted.. The difference in costs between the interventions was US$16.26, with a difference in effectiveness of 0.0067 disability adjusted life years averted. The incremental cost-effectiveness ratio for carbetocin compared with oxytocin for prevention of hemorrhage following cesarean delivery was US$2432.89 per disability adjusted life year averted.. Carbetocin is as efficacious and safe as oxytocin for primary prevention of hemorrhage in cesarean delivery in Ecuador. It is highly cost effective for reducing the need for additional uterotonic drugs in both emergency and elective cesarean delivery.

Topics: Cesarean Section; Cost-Benefit Analysis; Ecuador; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy Outcome; Quality-Adjusted Life Years

Informed consent is the heart of ethical research. For any consent to be ethically valid, it should meet certain critical criteria- disclosure and understanding of relevant information, decision making competency of the participants, voluntariness of the decision and documentation of the agreement. Meeting all these criteria to obtain ethically valid consent from laboring women while conducting intrapartum trials is challenging because there is little time available during labor to provide study specific information necessary for the participant to understand and decide to sign the consent form. Moreover, women during labor may be anxious and distressed due to labor pains which is thought to interfere with the capacity to make decisions in some cases. Emphasis on these concerns may ultimately lead to the exclusion of many eligible women in labor from intrapartum clinical trials. In this paper, we discuss the ethical challenges and also the proposed recommendations to obtain ethically valid consent from women for conducting intrapartum clinical trials.

Topics: Decision Making; Female; Humans; Informed Consent; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

To determine the economic impact of the introduction of carbetocin for the prevention of postpartum haemorrhage (PPH) at caesarean section, compared to oxytocin.. The model is a decision tree conducted from a UK National Health Service perspective. 1500 caesarean sections (both elective and emergency) were modelled over a 12 month period. Efficacy data was taken from a published Cochrane meta-analysis, and costs from NHS Reference costs, the British National Formulary and the NHS electronic Medicines Information Tool. A combination of hospital audit data and expert input from an advisory board of clinicians was used to inform resource use estimates. The main outcome measures were the incidence of PPH and total cost over a one year time horizon, as a result of using carbetocin compared to oxytocin for prevention of PPH at caesarean section.. The use of carbetocin compared to oxytocin for prevention of PPH at caesarean section was associated with a reduction of 30 (88 vs 58) PPH events (>500ml blood loss), and a cost saving of £27,518. In probabilistic sensitivity analysis, carbetocin had a 91.5% probability of producing better outcomes, and a 69.4% chance of being dominant (both cheaper and more effective) compared to oxytocin.. At list price, the introduction of carbetocin appears to provide improved clinical outcomes along with cost savings, though this is subject to uncertainty regarding the underlying data in efficacy, resource use, and cost.

Topics: Cesarean Section; Cost-Benefit Analysis; Decision Trees; Female; Humans; Models, Economic; Oxytocics; Oxytocin; Postpartum Hemorrhage

The aim of this study was to compare the costs of using carbetocin in the prevention of uterine atony following delivery of the infant by Cesarean section (C-section) under epidural or spinal anesthesia with standard methods of prevention (SMP).. This retrospective multicenter study was based on data from three medical centers. A questionnaire was developed to gather patient records on consumption and costs of resources related to C-section, prevention of uterine atony and postpartum hemorrhage (PPH) treatment. Six subpopulations were considered, depending on patient characteristics. The analysis covered two perspectives: that of the hospital and of the public payer.. The subpopulations were homogenous, which was a premise for pooling the data. The use of carbetocin in the prevention of uterine atony following Cesarean section generates savings for hospital in comparison with SMP (oxytocin) in 5 of 6 subpopulations. The biggest savings were observed amongst patients who experienced severe PPH and reached 2.6-6.2 thousand PLN per patient. Costs of services related to C-section borne by the hospitals were higher than the refund received from a public payer. The greatest underestimation reached 12.1 thousand PLN per patient. Nevertheless, loss generated by this underfunding was lower in carbetocin versus oxytocin group.. The use of carbetocin instead of SMP gives hospitals an opportunity to make savings as well as to reduce losses resulting from the underfunding of the services provided by the National Health Fund.

Topics: Adult; Anesthesia, Epidural; Anesthesia, Spinal; Cesarean Section; Drug Costs; Female; Humans; Oxytocics; Oxytocin; Postoperative Complications; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Uterine Inertia

The aim of the study was to compare the incidence of the use of additional uterotonics before and after the change of carbetocin to oxytocin for the prevention of postpartum hemorrhage after cesarean delivery in women with severe preeclampsia.. This was an observational retrospective before-and-after study.. Operating room, postoperative recovery area.. Sixty women with severe preeclampsia undergoing cesarean delivery under spinal anesthesia; American Society of Anesthesiologists 3.. Observational study.. Blood pressure, heart rate, and biological data (hemoglobin, platelets, haptoglobin, prothrombin time index, activated partial thromboplastin time ratio, blood uric acid, aspartate aminotransferase, alanine aminotransferase, serum urea, serum creatinine, and albumin).. The incidence of additional uterotonic administration in the carbetocin and oxytocin groups was 15% and 10%, respectively (P=.70).. As carbetocin appears to be as effective and safe as oxytocin in preeclamptic women, its advantages make it a good uterotonic option in this particular setting.

Topics: Adult; Anesthesia, Spinal; Cesarean Section; Drug Substitution; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pre-Eclampsia; Pregnancy; Retrospective Studies; Treatment Outcome; Young Adult

The aim of this retrospective observational study was to determine the efficacy of carbetocin in reducing blood loss and primary postpartum hemorrhage (PPH) in vaginal and cesarean deliveries in a tertiary hospital in Taiwan.. Eligible gravid women (27-41 weeks) with available data were categorized into those treated prophylactically with and without carbetocin. The primary outcome was blood loss and incidence of primary PPH as measured by intrapartum/intraoperative and postpartum (recovery room) blood loss.. In Taiwan, prophylactic use of carbetocin resulted in significantly less blood loss and incidence of PPH in cesarean than in vaginal deliveries.

Topics: Administration, Intravenous; Adult; Chi-Square Distribution; Delivery, Obstetric; Female; Gestational Age; Humans; Incidence; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Taiwan

The aim of the study was to compare the effectiveness of carbetocin and oxytocin for prevention of postpartum hemorrhage (PPH) after caesarean section.. We analyzed data from 279 patients who received 100 μg of carbetocin intravenously or 10 IU of oxytocin into the uterine muscle as a rudimentary treatment for prevention of PPH.. Blood loss was statistically significantly higher (p=0.0136) in the entire study group as compared to the oxytocin group, and in cases when additional uterotonics were administered (p=0.0090). Also, we observed a statistically significantly correlation between the need for additional treatment and patient BMI. Patients with pre-pregnancy BMI of ≥25 more often required additional medicaments after administration of carbetocin as compared to oxytocin (p=0.0077). We noted a statistically significantly higher rate of using additional treatment (p<0.05) after administering oxytocin into the uterine muscle as compared to intravenously given carbetocin (75% vs. 33%, respectively).. 1. Carbetocin is more effective than oxytocin in the prevention of PPH and significantly reduces the necessity to administer therapeutic uterotonics during caesarean delivery. 2. Higher rates of additional treatment with uterotonics after the administration of carbetocin as compared to oxytocin in a group of patients after2 or more cesarean sections and women with BMI of ≥25 require further studies in a target-selected larger sample size. 3. Based on our findings, it is not possible to conclude that 100 μg of intravenous carbetocin is more effective than 10 IU of oxytocin given to the uterine muscle during caesarean delivery to prevent PPH.

Topics: Adult; Cesarean Section; Delayed-Action Preparations; Dose-Response Relationship, Drug; Female; Humans; Injections, Intravenous; Oxytocin; Perinatal Care; Postpartum Hemorrhage; Pregnancy; Uterine Inertia; Young Adult

The aim of the study was to compare the effectiveness of Carbetocin versus Oxyotcin during caesarean section for preventing postpartum haemorrhage.. Prospective observational study (before/after design). Five hundred and forty patients who received an injection of Oxytocin were compared to 262 patients with single injection of 100 micrograms of Carbetocin. The primary outcome was to compare the differential hematocrit level between pre- and postoperative blood samples. The secondary outcome was to compare differential hemoglobin level and the use of complementary therapies for postpartum haemorrhage.. We did not find any difference between the Oxytocin and Carbetocin groups on differential hematocrit level. There was no difference between the groups regarding the use of additionnal therapies (Sulproston injections, blood transfusions and surgery methods). The rate of postpartum haemorrhage was similar in the two groups (18.7% vs 21.6%; P=0.33). We found a lower percentage of patients with differential of hemoglobin level between 2 g/dL and 4 g/dL in the Carbetocin group (6.5% vs 15.6%, P<0.001). The proportion of patients requiring intravenous iron administration was significantly lower in the Carbetocin group (6.8% vs 13.8%, P=0.0036) CONCLUSION: According to the primary outcome, there is no difference in effectiveness between carbetocin and oxytocin. Carbetocin seems to reduce the need for postoperative intravenous iron injection.

Topics: Adult; Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies

Topics: Adult; Analysis of Variance; Cesarean Section; Electrocardiography; Female; Humans; Long QT Syndrome; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

Cesarean deliveries of multiple pregnancies are associated with a high risk of hemorrhage. The aim of this study is to evaluate the efficacy of carbetocin administered systematically during cesarean deliveries of multiple pregnancies.. Single-center retrospective before-and-after study comparing the use of carbetocin to that of oxytocin during cesareans during two consecutive 6-month periods. A composite variable was predefined as the principal endpoint: any one or more of bleeding ≥1,500 mL, transfusion, hemoglobin reduction of 4 g/dL or more or operative intervention (surgery, embolization).. In an intention-to-treat analysis, the comparison of the two groups (n = 24 before and n = 39 after) showed no difference for the occurrence of the composite variable (16.7 vs. 15.4 %, p = 0.89). Nor did the per-protocol analysis (n = 24 before and n = 27 after) differ for it (16.7 vs. 14.8 %, p = 0.86). Moreover, none of the secondary outcome measures studied-moderate blood loss, prescription of sulprostone, cell-saver use, and intravenous iron infusion-differed significantly between the two periods.. In our population of multiple pregnancies delivered by cesarean, carbetocin did not appear more effective than oxytocin in preventing severe postpartum hemorrhage.

Topics: Adult; Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy, Multiple; Retrospective Studies; Treatment Outcome

Maternal mortality is a public health problem reflecting lack of infrastructure in health facilities or poor obstetrical training of those caring for pregnant women.. To report the results of a comprehensive program of the Health System of San Luis Potosi State, aimed at reducing maternal mortality in the period 2004-2008.. An observational and retrospective study based on information provided by the State Committee for the Study and Prevention of Maternal Mortality in the 58 municipalities, hospitals and medical units of the state of San Luis Potosi.. During the period 2004-2008, maternal mortality was reduced by 55% as a result of increased postpartum contraception coverage from 32 to 74% in general and community hospitals, and from 47 to 58% in health care units located in risk areas. In 2004, births fell by 5.8%. Between 1990 and 2003, 2,929 newborns were left maternal orphans, with an annual average of 209. During the study period, 423 infants were in the same situation, with an average of 70.. The present conditions of the social environment of San Luis Potosi are favourable to further reduce maternal mortality.

Topics: Child, Orphaned; Contraception; Female; Government Programs; Health Policy; Humans; Infant, Newborn; Maternal Health Services; Maternal Mortality; Mexico; Oxytocin; Postpartum Hemorrhage; Postpartum Period; Pregnancy; Retrospective Studies; Rural Population; Uterine Contraction; Uterine Hemorrhage

We report the case of a pregnancy of 16 weeks with anemia and a presumptive diagnosis of partial mole. In secondary care this diagnosis was ruled out through ultrasonography and diffuse cysts were found in the myometrium. Spectral Doppler ultrasound showed no flow, but it could be observed with power angiography. Cesarean section was performed at 38 weeks and hysterectomy 24 hours after because of intra-abdominal hemorrhage. Power angiography, spectral Doppler and serum human chorionic gonadotropin are the most useful diagnostic tools in the differential diagnosis of diffuse cavernous hemangioma of the uterus. Postpartum hemorrhage is a likely complication.

Topics: Blood Transfusion; Cesarean Section; Combined Modality Therapy; Diagnosis, Differential; Female; Hemangioma, Cavernous; Hemoperitoneum; Humans; Hydatidiform Mole; Hysterectomy; Infant, Newborn; Male; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Pregnancy Complications, Neoplastic; Ultrasonography; Uterine Neoplasms; Young Adult

Postpartum haemorrhage is a major cause of maternal morbidity and mortality worldwide. A recent Cochrane review of carbetocin (long-acting oxytocin analogue) concluded that its use decreased additional uterotonic requirements, however, no included studies compared its use against intravenous bolus oxytocin. The majority of studies of carbetocin have considered its use in vaginal delivery; no studies have examined the economic implications of its use. This study describes a clinical and financial evaluation undertaken at a United Kingdom District General Hospital surrounding the introduction of carbetocin for prophylaxis against postpartum haemorrhage at caesarean deliveries. A range of clinical outcomes were observed including frequency of postpartum haemorrhage, estimated blood loss, transfusion requirements, change in haemoglobin or haemodynamics, use of additional uterotonics and perioperative recovery. Finally, a composite financial analysis was performed. No clinically significant benefit was found, however associated costs increased by £18.52/patient.

Topics: Adult; Cesarean Section; Female; Health Care Costs; Humans; Morbidity; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; United Kingdom; Young Adult

Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

To compare the efficacy of carbetocin versus oxytocin, during delivery in patients undergoing a caesarian section.. A two phase observational study (before/after design) was conducted. Use of carbetocin was considered as a sentinel event. Data for 155 women who received carbetocin during a caesarian section were compared with 155 patients who received oxytocin. The main parameter evaluated was the need for haemostatic surgical techniques (vascular sutures, uterine compression sutures, emergent hysterectomy) during caesarian section.. Both populations were comparable, particularly concerning risk factors of postpartum haemorrhage. In the carbetocin group, there was fewer compression sutures during caesarian section (0.6% versus 4.5%, P=0.06), as well as a significant decrease in postoperative intravenous iron administration (6.5% versus 14.5%, P=0.03). Vascular sutures, frequencies of prostaglandin intravenous injections, and blood transfusions during caesarian section were similar in both populations. There wasn't any emergent hysterectomy during the time of this study.. Prevention of uterine atony during a caesarian section with carbetocin seems to be as effective as oxytocin. Particularly, decreasing rate of surgical compression sutures with use of carbetocin is not significant, and prospective studies with more patients are necessary to confirm these results.

Topics: Adult; Cesarean Section; Cohort Studies; Delayed-Action Preparations; Female; Hemostatic Techniques; Humans; Iron; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Treatment Outcome; Uterine Inertia

The aim of this study was to evaluate the efficacy of carbetocin in prevention of PPH in women after cesarean section.. We enrolled 60 patients who had undergone cesarean section in tertiary referential center, Department of Perinatology, Medical University of Lodz, Poland, between January and June 2008. Each patient obtained a single 100 microg dose of carbetocin intravenously during cesarean section, immediately after the delivery of the baby and prior to the delivery of the placenta. We evaluated postoperative blood parameters in 2 and 12 hours after the operation, the proportion of patients requiring additional uterotonic agents and adverse events in the whole population and in the group of women with high risk of PPH.. 58.1% of patients underwent emergency and 41.3% elective cesarean section delivery. The risk factor of PPH was identified in 38 women (63.3%). The results of this study indicate that carbetocin produces rapid and long-lasting uterine tone. A small drop in mean hemoglobin and hematocrit levels 2 and 12 hours after the operation was observed. 15% of patients required the use of additional uterotonic agents. In the group of women with high risk of PPH, carbetocin appeared to be effective in 79% of the patients. Only 11.4% of patients had minor adverse events.. Carbetocin appears to be an effective new drug in the prevention of postpartum hemorrhage, not only among women undergoing cesarean section but also in the group of women with PPH risk factors.

Topics: Adult; Cesarean Section; Delayed-Action Preparations; Female; Humans; Infant, Newborn; Intraoperative Care; Oxytocin; Poland; Postoperative Hemorrhage; Postpartum Hemorrhage; Pregnancy; Treatment Outcome

Topics: Drug Therapy, Combination; Ergonovine; Female; Hematocrit; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Treatment Outcome

To determine the maximum tolerated dose (MTD) of carbetocin (a long-acting synthetic analogue of oxytocin), when administered immediately after vaginal delivery at term.. Carbetocin was given as an intramuscular injection immediately after the birth of the infant in 45 healthy women with normal singleton pregnancies who delivered vaginally at term. Dosage groups of 15, 30, 50, 75, 100, 125, 150, 175 or 200 microg carbetocin were assigned to blocks of three women according to the continual reassessment method (CRM).. All dosage groups consisted of three women, except those with 100 microg (n=6) and 200 microg (n=18). Recorded were dose-limiting adverse events: hyper- or hypotension (three), severe abdominal pain (0), vomiting (0) and retained placenta (four). Serious adverse events occurred in seven women: six cases with blood loss > or = 1000 ml, four cases of manual placenta removal, five cases of additional oxytocics administration and five cases of blood transfusion. Maximum blood loss was greatest at the upper and lower dose levels, and lowest in the 70-125 microg dose range. Four out of six cases with blood loss > or = 1000 ml occurred in the 200 microg group. The majority of additional administration of oxytocics (4/5) and blood transfusion (3/5) occurred in the dose groups of 200 microg. All retained placentae were found in the group of 200 microg.. The MTD was calculated to be at 200 microg carbetocin.

Topics: Abdominal Pain; Female; Humans; Hypertension; Hypotension; Injections, Intramuscular; Oxytocics; Oxytocin; Placenta, Retained; Postpartum Hemorrhage; Pregnancy; Vomiting