misoprostol and Fever

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ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for unpublished trial reports (30 June 2015) and reference lists of retrieved studies..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 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

While inferior to oxytocin injection in both efficacy and safety, orally administered misoprostol has been included in the World Health Organization Model List of Essential Medicines for use in the prevention of postpartum haemorrhage (PPH) in low-resource settings. This study evaluates the costs and health outcomes of use of oral misoprostol to prevent PPH in settings where injectable uterotonics are not available.. A cost-consequences analysis was conducted from the international health system perspective, using data from a recent Cochrane systematic review and WHO's Mother-Baby Package Costing Spreadsheet in a hypothetical cohort of 1000 births in a mixed hospital (40% births)/community setting (60% births). Costs were estimated based on 2012 US dollars.. Using oxytocin in the hospital setting and misoprostol in the community setting in a cohort of 1000 births, instead of oxytocin (hospital setting) and no treatment (community setting), 22 cases of PPH could be prevented. Six fewer women would require additional uterotonics and four fewer women a blood transfusion. An additional 130 women would experience shivering and an extra 42 women fever. Oxytocin/misoprostol was found to be cost saving (US$320) compared to oxytocin/no treatment. If misoprostol is used in both the hospital and community setting compared with no treatment (i.e. oxytocin not available in the hospital setting), 37 cases of PPH could be prevented; ten fewer women would require additional uterotonics; and six fewer women a blood transfusion. An additional 217 women would experience shivering and 70 fever. The cost savings would be US$533. Sensitivity analyses indicate that the results are sensitive to the incidence of PPH-related outcomes, drug costs and the proportion of hospital births.. Our findings confirm that, even though misoprostol is not the optimum choice in the prevention of PPH, misoprostol could be an effective and cost-saving choice where oxytocin is not or cannot be used due to a lack of skilled birth attendants, inadequate transport and storage facilities or where a quality assured oxytocin product is not available. These benefits need to be weighed against the large number of additional side effects such as shivering and fever, which have been described as tolerable and of short duration.

Topics: Administration, Oral; Cost-Benefit Analysis; Female; Fever; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Parturition; Postpartum Hemorrhage; Pregnancy; Shivering

The primary objective of postpartum haemorrhage (PPH) prevention and treatment is to reduce maternal deaths. Misoprostol has the major public health advantage over injectable medication that it can more easily be distributed at community level. Because misoprostol might have adverse effects unrelated to blood loss which might impact on mortality or severe morbidity, it is important to continue surveillance of all relevant evidence from randomised trials. This is particularly important as misoprostol is being introduced on a large scale for PPH prevention in low-income countries, and is commonly used for PPH treatment in well-resourced settings as well.. To review maternal deaths and severe morbidity in all randomised trials of misoprostol for prevention or treatment of PPH.. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (11 January 2013).. We included randomised trials including pregnant women who received misoprostol in the postpartum period, versus placebo/no treatment or other uterotonics for prevention or treatment of PPH, and reporting on maternal death, severe morbidity or pyrexia.We planned to include cluster- and quasi-randomised trials in the analysis, as a very large number of women will be needed to obtain robust estimates of maternal mortality but we did not identify any for this version of the review. In future updates of this review we will include trials reported only as abstracts if sufficient information is available from the abstract or from the authors.. Two review authors independently assessed trials for inclusion and extracted data.. We included 78 studies (59,216 women) and excluded 34 studies.There was no statistically significant difference in maternal mortality for misoprostol compared with control groups overall (31 studies; 11/19,715 versus 4/20,076 deaths; risk ratio (RR) 2.08, 95% confidence interval (CI) 0.82 to 5.28); or for the trials of misoprostol versus placebo: 10 studies, 6/4626 versus 1/4707 ; RR 2.70; 95% CI 0.72 to 10.11; or for misoprostol versus other uterotonics: 21 studies, 5/15,089 versus 3/15,369 (19/100,000); RR 1.54; 95% CI 0.40 to 5.92. All 11 deaths in the misoprostol arms occurred in studies of misoprostol ≥ 600 µg.There was a statistically significant difference in the composite outcome 'maternal death or severe morbidity' for the comparison of misoprostol versus placebo (12 studies; average RR 1.70, 95% CI 1.02 to 2.81; Tau² = 0.00, I² = 0%) but not for the comparison of misoprostol versus other uterotonics (17 studies; average RR 1.50, 95% CI 0.50 to 4.52; Tau² = 1.81, I² = 69%). When we excluded hyperpyrexia from the composite outcome in exploratory analyses, there was no significant difference in either of these comparisons.Pyrexia > 38°C was increased with misoprostol compared with controls (56 studies, 2776/25,647 (10.8%) versus 614/26,800 (2.3%); average RR 3.97, 95% CI 3.13 to 5.04; Tau² = 0.47, I² = 80%). The effect was greater for trials using misoprostol 600 µg or more (27 studies; 2197/17,864 (12.3%) versus 422/18,161 (2.3%); average RR 4.64; 95% CI 3.33 to 6.46; Tau² = 0.51, I² = 86%) than for those using misoprostol 400 µg or less (31 studies; 525/6751 (7.8%) versus 185/7668 (2.4%); average RR 3.07; 95% CI 2.25 to 4.18; Tau² = 0.29, I² = 58%).. Misoprostol does not appear to increase or reduce severe morbidity (excluding hyperpyrexia) when used to prevent or treat PPH. Misoprostol did not increase or decrease maternal mortality. However, misoprostol is associated with an increased risk of pyrexia, particularly in dosages of 600 µg or more. Given that misoprostol is used prophylactically in very large numbers of healthy women, the greatest emphasis should be placed on limiting adverse effects. In this context, the findings of this review support the use of the lowest effective dose. As for any new medication being used on a large scale, continued vigilance for adverse effects is essential and there is a need for large randomised trials to further elucidate both the relative effectiveness and the risks of various dosages of misoprostol.

Topics: Female; Fever; Humans; Maternal Mortality; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic

Using misoprostol to prevent postpartum haemorrhage (PPH) in home-birth settings remains controversial.. To review the safety and effectiveness of oral misoprostol in preventing PPH in home-birth settings.. The Cochrane Library, PubMed, and POPLINE were searched for articles published until 31 March 2012.. Studies, conducted in low-resource countries, comparing oral misoprostol with a placebo or no treatment in a home-birth setting. Studies of misoprostol administered by other routes were excluded.. Data were extracted by two reviewers and independently checked for accuracy by a third. The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Data were sythesised and meta-analysis was performed where appropriate.. Ten papers describing two randomised and four non randomised trials. Administration of misoprostol was associated with a significant reduction in the incidence of PPH (RR 0.58, 95% CI 0.38-0.87), additional uterotonics (RR 0.34, 95% CI 0.16-0.73), and referral for PPH (RR 0.49, 95% CI 0.37-0.66). None of the studies was large enough to detect a difference in maternal mortality, and none reported neonatal mortality. Shivering and pyrexia were the most common side effects.. The finding that the distribution of oral misoprostol through frontline health workers is effective in reducing the incidence of PPH could be a significant step forwards in reducing maternal deaths in low-resource countries. However, given the limited number of high-quality studies in this review, further randomised controlled trials are required to confirm the association, particularly in different implementation settings. Adverse effects have not been systematically captured, and there has been limited consideration of the potential for inappropriate or inadvertent use of misoprostol. Further evidence is needed to inform the development of implementation and safety guidelines on the routine availability of misoprostol.

Topics: Administration, Oral; Developing Countries; Female; Fever; Home Childbirth; Humans; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Risk Factors; Shivering; Treatment Outcome

Prostaglandins have mainly been used for postpartum haemorrhage (PPH) when other measures fail. Misoprostol, a new and inexpensive prostaglandin E1 analogue, has been suggested as an alternative for routine management of the third stage of labour.. To assess the effects of prophylactic prostaglandin use in the third stage of labour.. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (7 January 2011). We updated this search on 25 May 2012 and added the results to the awaiting classification section.. Randomised trials comparing a prostaglandin agent with another uterotonic or no prophylactic uterotonic (nothing or placebo) as part of management of the third stage of labour. The primary outcomes were blood loss 1000 mL or more and the use of additional uterotonics.. Two review authors independently assessed eligibility and trial quality and extracted data.. We included 72 trials (52,678 women). Oral or sublingual misoprostol compared with placebo is effective in reducing severe PPH (oral: seven trials, 6225 women, not totalled due to significant heterogeneity; sublingual: risk ratio (RR) 0.66; 95% confidence interval (CI) 0.45 to 0.98; one trial, 661 women) and blood transfusion (oral: RR 0.31; 95% CI 0.10 to 0.94; four trials, 3519 women).Compared with conventional injectable uterotonics, oral misoprostol was associated with higher risk of severe PPH (RR 1.33; 95% CI 1.16 to 1.52; 17 trials, 29,797 women) and use of additional uterotonics, but with a trend to fewer blood transfusions (RR 0.84; 95% CI 0.66 to 1.06; 15 trials; 28,213 women). Additional uterotonic data were not totalled due to heterogeneity. Misoprostol use is associated with significant increases in shivering and a temperature of 38º Celsius compared with both placebo and other uterotonics.. Oral or sublingual misoprostol shows promising results when compared with placebo in reducing blood loss after delivery. The margin of benefit may be affected by whether other components of the management of the third stage of labour are used or not. As side-effects are dose-related, research should be directed towards establishing the lowest effective dose for routine use, and the optimal route of administration.Neither intramuscular prostaglandins nor misoprostol are preferable to conventional injectable uterotonics as part of the management of the third stage of labour especially for low-risk women; however, evidence has been building for the use of oral misoprostol to be effective and safe in areas with low access to facilities and skilled healthcare providers and future research on misoprostol use in the community should focus on implementation issues.

Topics: Administration, Oral; Administration, Sublingual; Female; Fever; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Prostaglandins; Randomized Controlled Trials as Topic; Shivering

To estimate the incidence and risk of misoprostol-induced fever with different doses and routes when used for the prevention of postpartum hemorrhage.. We searched MEDLINE, the Cochrane CENTRAL, and PubMed free-text terms "misoprostol AND third stage of labor," "misoprostol AND third stage of labour," "misoprostol AND postpartum hemorrhage," and "misoprostol AND postpartum haemorrhage." Randomized trials with at least one group randomized to misoprostol administered by any route to prevent postpartum hemorrhage were included.. Two hundred thirty-one studies were initially identified and 61 of them were assessed for eligibility. We excluded nonrandomized trials, studies without a control group, and trials that did not record the rate of fever. The date of last search was July 20, 2010. Data were extracted, tabulated, and analyzed with Reviewer Manager software.. We included 33 trials with 38,478 participants in the final analysis. The highest reported incidence of fever was in the sublingual route (15%) with lower rates with the oral (11.4%) and rectal (4%) routes. The overall risk ratio of fever with misoprostol in comparisons with placebo and other uterotonics was approximately 5. There was frequent heterogeneity, however, which could not be explained by study quality or publication date.. The incidence of fever with misoprostol is related to both its dosage and route with the highest incidences found in the high-dose sublingual routes. However, this is not the only influence on postnatal fever. There appear also to be other effects that could be genetic or cultural.

Topics: Female; Fever; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Chills; Congenital Abnormalities; Diarrhea; Drug Administration Schedule; Female; Fever; Gestational Age; Humans; Milk, Human; Misoprostol; Muscle Cramp; Nausea; Pregnancy; Uterine Hemorrhage; Vomiting

To systematically review the efficacy of misoprostol compared with placebo or other uterotonics in preventing maternal morbidity associated with the third stage of labor.. We identified, retrieved, evaluated, abstracted data, and assessed the quality of all published studies (from January 1996 to May 2002) which assessed misoprostol's efficacy in minimizing uterine blood loss during the third stage of labor. Seventeen studies included 28170 subjects; of these, approximately one-half received misoprostol with the remainder receiving either a placebo or another uterotonic agent. An estimate of the odds ratio (OR) and risk difference for dichotomous outcomes was calculated using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means.. In assessing studies comparing misoprostol with placebo, those who received oral misoprostol had a decreased risk of needing additional uterotonics (OR 0.64, 95% confidence interval 0.46, 0.90). Compared with placebo, use of misoprostol was associated with an increased risk for shivering and pyrexia. In contrast, in studies comparing misoprostol with oxytocin, oxytocin was associated with significantly lower rates of postpartum hemorrhage, maternal shivering and pyrexia. In studies comparing misoprostol with Syntometrine, misoprostol was associated with higher rates of the need for additional uterotonic agent as well as shivering.. Misoprostol was inferior to oxytocin and other uterotonics with regard to any of the third stage of labor outcomes assessed. However, when compared to placebo, misoprostol had a decreased risk of needing additional uterotonics. Thus, in less-developed countries where administration of parenteral uterotonic drugs may be problematic, misoprostol represents a reasonable agent for the management of the third stage of labor. Additional randomized clinical trials examining objective outcome measures (i.e. need for blood transfusion or 10% hemoglobin change) may further define benefits and risks of misoprostol use during the third stage of labor.

Topics: Female; Fever; Humans; Labor Stage, Third; Labor, Obstetric; Misoprostol; Oxytocics; Placebo Effect; Postpartum Hemorrhage; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic; Shivering; Treatment Outcome

Misoprostol is an effective agent for the induction of labor. Existing guidelines recommend oral misoprostol solution 25 μg every 2 hours. However, more research is required to optimize the use of oral misoprostol solution for the induction of labor.. The purpose of this study was to compare efficacy and safety of hourly titrated-dose oral misoprostol solution with static-dose oral misoprostol solution every 2 hours for labor induction.. In this randomized controlled study, oral misoprostol solution was administered as (1) 20 μg hourly (≤4 doses) that was increased in the absence of regular uterine contractions to 40 μg hourly (≤4 doses) and then to 60 μg hourly (≤16 doses) or (2) 25 μg every 2 hours until active labor began (≤12 doses). A sample size of 146 women was planned with the use of a projected 95% rate for the primary endpoint (vaginal delivery within 24 hours) for hourly titrated-dose misoprostol and 80% rate for static-dose misoprostol every 2 hours. Safety outcomes included maternal morbidity and adverse neonatal outcomes.. From December 2013 to July 2015, 146 women were assigned randomly to treatment. Demographic and clinical factors were similar between groups, except for age. Vaginal delivery was achieved within 24 hours in 47 women (64.4%) who received hourly titrated-doses of misoprostol solution and 48 women (65.8%) who received 2-hourly static-dose misoprostol solution (P=1.00). Rates of vaginal delivery within 24 hours did not differ significantly between treatment groups for women who were nulliparous (P=1.00) or who had postterm pregnancies (P=.66), a Bishop score of ≤3 (P=.84), or oxytocin augmentation (P=.83). Cesarean deliveries were performed within 24 hours in 9 women who received hourly titrated-dose misoprostol solution and 2 women who received 2-hourly static-dose misoprostol solution (P=.056). Pyrexia and meconium-stained liquor occurred more frequently with the hourly titrated-dose regimen.. The static-dose oral misoprostol solution every 2 hours has similar efficacy as hourly titrated-dose misoprostol solution but with fewer side-effects and lower complication rates.

Topics: Administration, Oral; Adolescent; Adult; Cervical Ripening; Delivery, Obstetric; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fever; Humans; Labor, Induced; Meconium; Misoprostol; Oxytocics; Pregnancy; Time Factors; Young Adult

To compare efficacy and adverse effects of 200μg and 400μg misoprostol for prevention of postpartum hemorrhage (PPH).. In a randomized control trial, women with term singleton pregnancies in active labor attending University College Hospital, Ibadan, Nigeria, were enrolled between July 2011 and February 2012. Participants were randomly assigned using random numbers (block size four) to receive 200μg or 400μg sublingual misoprostol after delivery of the anterior shoulder, alongside intravenous oxytocin. Investigators were masked to group assignment, but participants were not. The primary outcomes were blood loss up to 1h after delivery, PPH (blood loss ≥500mL), and adverse effects.. Overall, 62 patients were assigned to each group. No significant differences between the 200-μg and 400-μg groups were recorded in mean peripartum blood loss (307±145mL vs 296±151mL; P=0.679) and PPH occurrence (5 [8.1%] vs 6 [9.7%] women; P=0.752). Noticeable adverse effects were reported by 16 (25.8%) women in the 200-μg group and 42 (67.7%) in the 400-μg group (P<0.001). Risk of shivering was significantly lower with 200μg than 400μg (relative risk 0.33, 95% confidence interval 0.19-0.58).. Blood loss and PPH occurrence did not differ by misoprostol dose, but a 200-μg dose was associated with a reduction in adverse effects. Pan Africa Clinical Trials Registry: PACTR201505001107182.

Topics: Administration, Sublingual; Adult; Female; Fever; Humans; Misoprostol; Nigeria; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Shivering; Tertiary Care Centers; Treatment Outcome

To evaluate whether a combination of misoprostol and oxytocin more effectively reduces blood loss during and after cesarean delivery than does oxytocin alone among women with known risk factors for postpartum hemorrhage (PPH).. A prospective, randomized, double-blind, placebo-controlled trial was performed at a tertiary care center in Kolkata, India, between October 2012 and December 2013. Women were eligible if they were undergoing emergency cesarean under spinal anesthesia and were at high risk for PPH. Participants were randomly assigned (1:1) to receive 400 μg misoprostol or matched placebo sublingually after delivery of the newborn using a computer-generated random number sequence (block size eight). Participants and providers were masked to assignment. All participants received 20 IU oxytocin. The primary outcomes were intraoperative and postoperative blood loss.. Both groups contained 198 women. Mean intraoperative blood loss was significantly lower in the misoprostol group (505.4±215.5 mL) than in the placebo group (587.3±201.5 mL; P<0.001). Mean postoperative blood loss was slightly lower in the misoprostol group (96.9±57.3 mL) than in the placebo group (103.4±58.4 mL; P=0.07). Shivering and pyrexia were more frequently associated with misoprostol (P<0.05 for both).. Misoprostol as an adjunct to oxytocin seemed to more effectively reduce blood loss than did oxytocin alone. Clinical Trial Registry India:CTRI/2013/05/003645.

Topics: Abortifacient Agents, Nonsteroidal; Administration, Sublingual; Adult; Blood Loss, Surgical; Blood Volume; Cesarean Section; Double-Blind Method; Drug Therapy, Combination; Emergencies; Female; Fever; Humans; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Risk Factors; Shivering; Young Adult

To compare the efficacy of oral misoprostol with that of oxytocin for active management of the third stage of labor (AMTSL).. A double-blind randomized control trial was undertaken at a center in Ilorin, Nigeria, between January and June 2013. Every other eligible patient (in the first stage of labor at term, to have a spontaneous vaginal delivery, and no/low risk of postpartum hemorrhage [PPH]) were randomly assigned with computer-generated random numbers to receive oral misoprostol (600μg) plus placebo injection or oral placebo plus oxytocin injection (1mL of 10IU) in the third stage of labor. The primary outcome was amount of blood loss during delivery.. Mean postpartum blood loss was 325.85±164.72mL in the 100 patients given misoprostol and 303.95±163.33mL in the 100 patients given oxytocin (P=0.391). PPH (≥500mL blood loss) was recorded in 15 (15.0%) patients given misoprostol and 14 (14.0%) given oxytocin (P=0.841). Shivering, pyrexia, and diarrhea were all significantly more common in the misoprostol group (P<0.01 for all).. The efficacy of oral misoprostol was similar to that of intramuscular oxytocin. Adverse effects associated with misoprostol were transient and self-limiting. Thus, oral misoprostol is efficacious and a good alternative to oxytocin for AMTSL. Pan African Clinical Trials Registry:PACTR201407000825227.

Topics: Administration, Oral; Adult; Blood Volume; Diarrhea; Double-Blind Method; Female; Fever; Hospitals; Humans; Injections, Intramuscular; Labor Stage, Third; Misoprostol; Nigeria; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Shivering; Young Adult

Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH.. Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600 mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2 g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant.. 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4% vs intervention 91.4%, mean difference = -11.0%, 95% confidence interval [CI] -25.7% to 3.6%, p = 0.11). No woman took misoprostol before their baby's birth. Shivering and fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean difference = -7.2%, 95% CI -11.1% to -3.7%), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4% in the intervention arm (mean difference = 7.1%, 95% CI -3.1% to 17.3%, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95% CI -12.7 to 2.9), p = 0.17).. This study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol. The study was registered with Pan-African Clinical Trials Network ( PACTR201303000459148, on 19/11/2012).

Topics: Administration, Oral; Adult; Cluster Analysis; Delivery, Obstetric; Drug Administration Schedule; Female; Fever; Hemoglobins; Home Childbirth; Humans; Misoprostol; Oxytocics; Postpartum Hemorrhage; Postpartum Period; Pregnancy; Self Administration; Shivering; Uganda; Young Adult

The goal of this study was to compare the effectiveness of misoprostol via sublingual and vaginal administration versus the combination route in the termination of 13 to 24 week pregnancies.. One hundred and ninety-five patients, divided into three groups, were enrolled in this study. In the vaginal group, two 200-μg misoprostol tablets were inserted into the posterior fornix every 4 hours for 48 hours. In the sublingual group, patients took two 200-μg misoprostol tablets every 4 hours for up to 48 hours. In the combination group, two 200-μg misoprostol tablets were inserted within the posterior fornix followed by the administration of 400 μg misoprostol sublingually every 4 hours for a period of 48 hours. Efficacy was defined as a successful termination without the need for any interventions.. The success rate, after 24-48 hours, was not significantly different among the three groups. It was significantly higher within the first 12 hours of misoprostol administration within the sublingual group (p = 0.031). Nonetheless, the overall failure rate was not significantly different between three groups. The mean duration of abortion was shortest among the sublingual group (655 ± 46 minutes), p = 0.005, and the number of misoprostol tablets administered was lower when compared to the other groups (5.9 ± 0.3), p = 0.001. The duration of abortion and the number of misoprostol tablets used significantly varied in the cases in which the patient had a history of a previous normal vaginal delivery (NVD; p = 0.007). The average number of tablets administered was the lowest in the sublingual group. The prevalence of fever among the NVD cases were significantly higher in the combination group (p = 0.008). Overall, of all the methods, patients preferred the sublingual route (p = 0.001).. Sublingual misoprostol has a higher efficacy when compared to the vaginal and combination methods.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Administration, Sublingual; Adult; Female; Fever; Humans; Misoprostol; Patient Preference; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second

Post-partum hemorrhage (PPH) is the most common direct cause of maternal mortality and timely intervention can save many lives.. To compare the effectiveness of sublingual misoprostol to intravenous oxytocin in preventing post-partum hemorrhage in low risk vaginal birth.. One hundred patients with no risk factor for PPH were randomly allocated to receive 600 μg misoprostol administered sublingually or 10 IU of intravenous oxytocin immediately after the delivery of baby. Main outcome measures were post-partum blood loss, drop in hemoglobin in 24 h, duration of third stage of labor, and drug-related adverse effects.. Mean age, parity and gestational age were similar in both groups. Mean blood loss was significantly lower in oxytocin group (114.28 ± 26.75 versus 149.50 ± 30.78 ml; p = 0.00). Drop in hemoglobin was 0.31 ± 0.16 versus 0.49 ± 0.21 g% (p = 0.01) in oxytocin and misoprostol group, respectively. Duration of third stage labor was shorter in oxytocin group (median 5 min, IQR: 4.5-5.5 versus 5.5 min, IQR: 5-6 min, p < 0.01). Although fever and shivering were common adverse effects with misoprostol but were not clinically significant.. Intravenous oxytocin is more efficacious than sublingual misoprostol in preventing PPH in institutional deliveries.

Topics: Administration, Sublingual; Adult; Delivery, Obstetric; Female; Fever; Hemoglobins; Humans; Infusions, Intravenous; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Shivering; Time Factors

The aim of the study was to compare the efficacy of sublingual misoprostol in addition to intravenous oxytocin, with oxytocin alone, in reducing blood loss during and following caesarean section. A total of 120 women undergoing caesarean delivery at the University College Hospital, Ibadan, were randomised into two equal groups. In Group A, 20 IU of intravenous oxytocin was given after umbilical cord clamping, while in Group B, the women received 400 μg misoprostol sublingually and 20 IU oxytocin intravenously. The outcome measures were blood loss, additional uterotonics, change in packed cell volume and side-effect profile. Associations between variables were determined by the χ(2) and Student's t-test. Relative risks were calculated for side-effects; the level of significance was p < 0.05. Intraoperative and postoperative blood loss were significantly lower in Group B (451.3 ml vs 551.2 ml, p = 0.007; 22.7 vs 42.2 ml, p < 0.001, respectively). In Group B, women were 7.4 (p < 0.001) and 9.0 (p = 0.008) times more likely to experience shivering and fever, respectively. The need for additional uterotonics was greater in the oxytocin group (66.7% vs 27.6%, p < 0.001). The addition of sublingual misoprostol to intravenous oxytocin reduces postpartum blood loss and the need for additional uterotonics. There is however, an increased risk of shivering and fever with this combination.

Topics: Administration, Sublingual; Adult; Cesarean Section; Drug Therapy, Combination; Female; Fever; Humans; Misoprostol; Oxytocics; Oxytocin; Postoperative Hemorrhage; Pregnancy; Shivering; Young Adult

To compare sublingual misoprostol with intramuscular oxytocin for prevention of postpartum hemorrhage (PPH) in low-risk vaginal birth.. In a prospective, randomized, double-blind trial, 530 women without risk of PPH were randomly allocated to receive either 400 μg of misoprostol sublingually or 10 units of oxytocin intramuscularly within 1minute of delivery. The outcome measures were incidence of PPH, postpartum blood loss, drop in hemoglobin level in 24 hours, need for additional uterotonic drug, incidence of adverse effects, and need for blood transfusion. Student t, χ(2), Mann-Whitney U, and Fisher exact tests were used for comparison.. Incidence of postpartum hemorrhage (≥ 500 mL) and postpartum blood loss in the misoprostol group were similar to those in the oxytocin group (6% versus 5.7%, P=0.85; 153 mL versus 146 mL, P=0.36). Shivering and pyrexia were encountered more often in the misoprostol than in the oxytocin group (shivering: 19% versus 0.8%, P<0.001, relative risk [RR] 0.86, 95% confidence interval [CI] 0.82-0.90; pyrexia: 2.3% versus 0%, P=0.03, RR 0.97, 95% CI 0.95-0.99).. The efficacy of 400 μg of misoprostol administered sublingually was equivalent to that of 10 units of oxytocin given intramuscularly for prevention of PPH in low-risk vaginal delivery.

Topics: Administration, Sublingual; Adolescent; Adult; Double-Blind Method; Female; Fever; Follow-Up Studies; Humans; Injections, Intramuscular; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Shivering; Statistics, Nonparametric; Treatment Outcome; Young Adult

To assess the effects of 400-μg sublingual misoprostol plus routine uterotonics on postpartum hemorrhage.. A double-blind, placebo-controlled, randomized study was performed. After delivery of the child, eligible women received routine uterotonics and were randomly allocated to receive 400-μg misoprostol or placebo sublingually. The primary outcome measure was blood loss of at least 500 mL within 1 hour of taking the trial tablets.. In total, 672 women received misoprostol and 673 received placebo. The baseline data were similar for both groups. Misoprostol plus routine uterotonics reduced postpartum blood loss, but the effect was not significant for blood loss of at least 500 mL (relative risk [RR] 0.96; 95% confidence interval [CI], 0.63-1.45) or blood loss of at least 1000 mL (RR 0.50; 95% CI, 0.15-1.66). Misoprostol also reduced the need for non-routine oxytocin, manual removal of the placenta, and hysterectomy, but these differences were not significant either. Misoprostol was associated with pyrexia and moderate/severe shivering. There was no death in either group.. Misoprostol plus routine uterotonics resulted in modest reductions of blood loss in the third stage of labor, but the effects did not reach statistical significance. Larger studies are recommended.

Topics: Administration, Sublingual; Adult; Double-Blind Method; Female; Fever; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Shivering

To investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH).. One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe.. Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns.. Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.

Topics: Administration, Oral; Diarrhea, Infantile; Female; Fever; Humans; Incidence; India; Infant, Newborn; Maternal-Fetal Exchange; Misoprostol; Nausea; Oxytocics; Placebos; Postpartum Hemorrhage; Pregnancy; Residence Characteristics; Rural Population; Shivering; Vomiting

To compare the efficacy and adverse effects of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor (AMTSL).. A double-blind randomized trial of 300 women with a healthy singleton pregnancy allocated into 4 groups to receive either: 400 microg or 600 microg of sublingual misoprostol, 5 IU of intravenous oxytocin, or 200 microg of intravenous methylergometrine. The primary outcome measure was blood loss in the third and fourth stage of labor; secondary measures were duration of the third stage of labor, changes in hemoglobin levels, and adverse effects.. Patients who received 600 microg of misoprostol had the lowest blood loss (96.05+/-21.1 mL), followed by 400 microg of misoprostol (126.24+/-49.3 mL), oxytocin (154.7+/-45.7 mL), and methylergometrine (223.4+/-73.7 mL) (P<0.01). Shortest mean duration of the third stage of labor (5.74 minutes) was with 600 microg of misoprostol, while methylergometrine had the longest (6.83 minutes) (P<0.05). Pyrexia was observed in the misoprostol groups, and raised blood pressure in the methylergometrine group (P<0.001). The 24-hour postpartum hemoglobin level was similar among the groups (P>0.05).. Administration of 600 microg of sublingual misoprostol was more effective than 400 microg of misoprostol, intravenous oxytocin, and intravenous methylergometrine for AMTSL.

Topics: Administration, Sublingual; Adult; Blood Pressure; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fever; Hemoglobins; Humans; Infusions, Intravenous; Labor Stage, Third; Methylergonovine; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Postpartum Period; Pregnancy; Time Factors; Young Adult

To compare the effects of oral misoprostol 800 mug with intramuscular oxytocin 10 IU in routine management of the third stage of labour.. This randomized controlled trial was performed in a rural district hospital in Ghana, West Africa, and enrolled women in labour with anticipated vaginal delivery and no known medical contraindication to prostaglandin administration. Women were randomized to receive oral misoprostol 800 mug or intramuscular oxytocin 10 IU. Blood samples were taken to determine hemoglobin concentration before delivery and at 12 hours post partum. Treatment was administered at delivery of the anterior shoulder. The primary outcome was the change in hemoglobin concentration from before to after delivery. Secondary outcomes included other measures of blood loss and presumed medication side effects.. In total, 450 women were enrolled in the study. Their baseline characteristics were similar. There was no significant difference between the groups in the change in hemoglobin concentration (misoprostol 1.07 g/dL and oxytocin 1.00 g/dL). The only significant secondary outcomes were shivering (80.7% with misoprostol vs. 3.6% with oxytocin) and pyrexia (11.4% with misoprostol, none with oxytocin).. Routine use of oral misoprostol 800 microg appears to be as effective as 10 IU parenteral oxytocin in minimizing blood loss during the third stage of labour, as determined by change in hemoglobin concentration. Misoprostol appears to be a safe, inexpensive, and effective uterotonic for use in rural and remote areas, where intravenous oxytocin may be unavailable.

Topics: Administration, Oral; Adult; Developing Countries; Double-Blind Method; Female; Fever; Ghana; Hemoglobins; Humans; Injections, Intramuscular; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Pregnancy; Shivering; Treatment Outcome

The search continues for a safe, effective, and cheap method for mid-trimester termination of pregnancy. Misoprostol is a strong contender in this respect. The dose schedule of misoprostol is still not fixed. The objective of our present study was to compare the efficacy and adverse events of 2 dose regimens of vaginal misoprostol for second trimester termination.. A prospective, randomised, controlled trial was undertaken in 138 women at 14-20 weeks gestation, in a teaching hospital. Subjects were randomised to receive either regime A: 400 microg of intravaginal misoprostol every 3 h, or regime B: loading dose of 600 microg, followed by 200 microg every 3 h. The main outcome measure was the success rate at 48 h, total dose required, induction-abortion interval, and adverse events. Data was analysed by Student's t-test, Mann-Whitney U-test, the chi-squared test or Fisher's exact test, using Statistica 6.0 software.. There was no significant difference in the success rates at 24 and 48 h (Regime A: 97.18 and 98.59%; Regime B: 95.45 and 95.45%), and in mean induction-abortion interval (12.97 versus 12.13 h). However, mean misoprostol requirement was significantly higher for Regime A (1701.4 versus 1269.7 microg). The incidence of fever was significantly less in Regime B (32.4 versus 14.9%).. Use of vaginal misoprostol for second trimester abortion had comparable efficacy with less drug requirement for the 600 microg loading dose followed by 200 microg 3-hourly regime compared to the 400 microg 3-hourly regime.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adolescent; Adult; Chi-Square Distribution; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fever; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, Second; Prospective Studies; Safety; Statistics, Nonparametric; Time Factors; Treatment Outcome

Our purpose was to compare the efficacy of oral misoprostol with that of vaginal misoprostol for midtrimester termination of pregnancy.. Women seen for midtrimester pregnancy termination were randomly assigned to receive either misoprostol orally in a dose of 200 microg every hour for 3 hours followed by 400 microg every 4 hours or vaginally in a dose of 400 microg every 4 hours. The protocol was followed for 24 hours, after which time further management was at the discretion of the attending physician. The primary outcome measure was the induction-to-delivery interval. Sample size was calculated a priori. Statistical analysis was performed with the t test for continuous variables and the chi(2) test for categorical variables. P <.05 was considered significant.. One hundred fourteen women were randomized, with 49 receiving vaginal misoprostol and 65 receiving oral misoprostol. The two groups were comparable with respect to maternal age, parity, indication for pregnancy termination, gestational age, and maternal weight. The mean induction-to-delivery interval was significantly shorter for the vaginal group (19.6 +/- 17.5 hours vs 34.5 +/- 28.2 hours, P <.01). Length of stay was also shorter in the vaginal group (32.3 +/- 17.3 hours vs 50.9 +/- 27.9 hours, P <.01). Significantly more patients in the vaginal group were delivered within 24 hours (85.1% vs 39.5%, P <.01), and more patients in the oral group required changes in the method of induction when they were undelivered after 24 hours (38.2% vs 7%, P <.01). The only complication was an increase in febrile morbidity in the vaginal group (25% vs 6.7%, P =.046). This did not result in an increased use of antibiotics, and all the fevers resolved post partum without further complications.. Vaginal administration of misoprostol resulted in a shorter induction-to-delivery interval. The shorter length of stay should result in improved patient care.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Administration, Oral; Adult; Delivery, Obstetric; Female; Fever; Humans; Length of Stay; Misoprostol; Pregnancy; Pregnancy Trimester, Second; Puerperal Disorders; Retreatment; Time Factors

The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor.. In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery.. The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy.. Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage.

Topics: Administration, Rectal; Adult; Drug Therapy, Combination; Female; Fever; Humans; Labor Stage, Third; Methylergonovine; Misoprostol; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy

To evaluate the side effects of 600 microg misoprostol orally during the first 24 hours after administration in the third stage of labour.. Double blind randomised controlled trial.. Tertiary care hospitals in Nigeria and Thailand.. All women participating in the WHO Misoprostol trial in these two hospitals between January 1, 1999 and June 17, 1999.. All women were followed up during the first 24 hours postpartum to evaluate the occurrence of shivering, nausea, vomiting, diarrhoea and other misoprostol-related side effects.. Rates of shivering, nausea, vomiting, diarrhoea and pyrexia within 1 hour and in the intervals 2-6, 7-12, 13-18 and 19-24 hours after delivery.. A total of 1686 women were enrolled. Women who received misoprostol had higher incidence than the oxytocin group of 'any' shivering in the first hour (RR 6.4, 95% CI 3.9 to 10.4) and the period covering 2-6 hours following delivery (RR 4.7, 95% CI 1.9 to 11.2). Pyrexia was also more common in the misoprostol group in both the same time intervals (RR 2.8, 95% CI 1.4 to 5.3 and RR 6.3, 95% CI 3.7 to 10.8, respectively). Diarrhoea was not present in the first hour in either group but appeared in the second time period (2-6 hours) and third time period (7-12 hours) more frequently in the misoprostol group than with oxytocin.. The increased incidence of shivering and pyrexia that occurs with postpartum use of misoprostol persists up to 6 hours following delivery. Approximately 5% of women experience diarrhoea that starts after 1 hour and subsides within 12 hours.

Topics: Administration, Oral; Diarrhea; Double-Blind Method; Female; Fever; Follow-Up Studies; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Puerperal Disorders; Risk Factors; Shivering; Time Factors

The objectives of this prospective non-concurrent cohort study were to confirm the efficacy of vaginal misoprostol for early pregnancy termination and to determine whether the incidence of side effects is lower with prophylactic loperamide and acetaminophen. Two-hundred women with an intrauterine pregnancy < or =56 days gestational age seeking medical pregnancy termination in an ambulatory research clinic were enrolled in the study. One-hundred participants (group 1) ingested 4 mg of loperamide and 500 mg of acetaminophen before the vaginal placement of 800 mirog of misoprostol moistened with 2 mL of saline. If abortion had not occurred, the same regimen was repeated every 24 h (maximum three doses). One-hundred participants (group 2) from the same clinic who previously underwent the same misoprostol regimen without prophylactic medication served as a control group for comparison with respect to abortion success and the incidence of side effects. The rate of successful abortion was not statistically significantly different between the two groups (group 1 93%, group 2 89%). The incidence of opiate analgesic use was significantly less in group 1 (4%) compared with group 2 (16%) (OR 0.22, 95% CI 0.06-0.73, p = 0.01). There was a significantly lower incidence of diarrhea in group 1 (23%) compared with group 2 (44%) (OR 0.38, 95% CI 0.20-0.73, p = 0.003). There was no difference in the incidence of fever/chills or the incidence of emesis between the two groups. Vaginal misoprostol is effective for termination of pregnancy < or = 56 days and the incidence of diarrhea and the use of opiate analgesia is significantly reduced with prophylactic loperamide and acetaminophen.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Acetaminophen; Administration, Intravaginal; Adolescent; Adult; Analgesics, Non-Narcotic; Antidiarrheals; Cohort Studies; Diarrhea; Female; Fever; Gestational Age; Humans; Loperamide; Middle Aged; Misoprostol; Patient Satisfaction; Pregnancy; Surveys and Questionnaires; Vomiting

Misoprostol, an inexpensive, stable, orally active prostaglandin analogue, has been suggested for use in the prevention of postpartum haemorrhage. Potential side-effects, however, need to be quantified.. To compare the rate of postpartum shivering and pyrexia following oral misoprostol 600 micrograms and placebo.. A double-blind placebo-controlled trial. Women in labour were randomly allocated to receive either misoprostol 600 micrograms orally or placebo after delivery. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Side-effects were recorded. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan.. The labour ward of an academic hospital in Johannesburg, with 7,000 deliveries per annum.. Shivering and pyrexia.. The groups were well matched. Misoprostol use was associated with more shivering (44% versus 11%, relative risk (RR) 4.03, 95% confidence interval (CI) 2.85-5.70), pyrexia > or = 37.8 degrees C (38% v. 6%, RR 6.23, CI 3.89-9.97), 1-hour systolic blood pressure > or = 140 mmHg (33% v. 25%, RR 1.32, CI 1.03-1.70), and diastolic blood pressure > or = 90 mmHg (10.5% v. 3.0%, RR 3.44, CI 1.67-7.11). There were no other significant differences. The study was not designed to be large enough to assess a difference in blood loss > or = 1,000 ml (9% v. 9.7%, RR 0.93, CI 0.56-1.53). Possible effects on blood loss may have been obscured by the lesser use of additional oxytocics in the misoprostol group (14% v. 18%, RR 0.78, CI 0.54-1.13).. This study has shown the association of postpartum oral misoprostol 600 micrograms with shivering, pyrexia and hypertension. The increased blood pressure, as for the trend towards increased abdominal pain, may be secondary to the uterotonic effect of misoprostol. Large randomised trials are needed to assess the effectiveness of misoprostol in the prevention of postpartum haemorrhage, against which the disadvantages demonstrated here can be weighed.

Topics: Adult; Double-Blind Method; Female; Fever; Humans; Hypertension; Labor Stage, Third; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Prospective Studies; Puerperal Disorders; Shivering; Treatment Outcome

A prospective randomized trial was conducted in 148 women to compare the efficacy of two regimens of vaginal misoprostol for termination of second trimester pregnancy. Women aged 16-40 years requesting termination of second trimester pregnancy were randomized into two groups. Women in group 1 were given vaginal misoprostol 400 microg every 3 h for a maximum of five doses in 24 h. Women in group 2 were given vaginal misoprostol 400 microg every 6 h for a maximum of three doses in 24 h. If women did not abort in 24 h, the same regimen was repeated. The median induction-abortion interval in group 1 (15.2 h) was significantly shorter (P < 0.01) than that in the group 2 (19.0 h). The percentage of women who achieved successful abortion within 48 h in group 1 (90.5%) was also significantly higher (P < 0.02) than that in group 2 (75.7%). The incidence of fever was more common in group 1 (P = 0.01). It is concluded that the regimen of vaginal misoprostol 400 microg every 3 h with maximum of five doses in 24 h was more effective than the regimen of misoprostol every 6 h in termination of second trimester pregnancy.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adult; Female; Fever; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, Second

To select the misoprostol dose to be used in a large multicentre randomised trial comparing misoprostol with oxytocin in the routine management of the third stage of labour.. Randomised pilot trial, double-blinded with the use of double placebos.. Two of the nine hospitals that will participate in the main multicentre trial. The hospitals were located in Johannesburg, South Africa and Khon Kaen, Thailand.. Women during second stage of labour about to be delivered vaginally.. The trial had three arms: misoprostol 400 microg versus misoprostol 600 microg versus intramuscular oxytocin 10 IU. Each group received an injection and three tablets immediately after the birth of the baby.. Shivering and pyrexia rates were the main outcome measures. Data on other side effects and characteristics of the third stage of labour were also collected. Side effects were noted as none, mild, moderate or severe.. Both shivering and pyrexia (temperature > 38 degrees C) were most common in the 600 microg misoprostol group (28% and 7.5% for shivering and pyrexia, respectively) compared with 400 microg misoprostol (19% and 2%), and the oxytocin group (12.5% and 3%). The increase in shivering in the misoprostol 600 microg group was due primarily to a higher rate of moderate shivering. None of the women had a temperature > 40 degrees C. There were no increases in severe side effects and other adverse events in the misoprostol 600 microg group.. When used in the management of the third stage of labour oral misoprostol is associated with an increase in the rate of moderate shivering and pyrexia which seems to be dose-related. Based on the results of this pilot trial, the Steering Committee has decided to use 600 microg misoprostol in the main trial, comparing it with oxytocin, in order to achieve higher effectiveness.

Topics: Adult; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fever; Humans; Misoprostol; Obstetric Labor Complications; Oxytocics; Oxytocin; Pilot Projects; Pregnancy; Shivering

A prospective randomized trial was conducted in 140 women to compare the efficacy of vaginal gemeprost with vaginal misoprostol for termination of second trimester pregnancy. Women requesting termination of second trimester pregnancy were randomized into two groups. Group A women were given 1 mg vaginal gemeprost every 3 h for a maximum of five doses in the first 24 h, whereas group B women were given 400 micrograms vaginal misoprostol every 3 h for a maximum of five doses in 24 h. The median induction-abortion interval in the vaginal misoprostol group (14.1 h) was significantly shorter than that in the gemeprost group (19.5 h). The percentage of women who achieved successful abortion within 24 h in the misoprostol group (80.0%) was significantly higher than that in the gemeprost group (58.6%). There was no significant difference in the incidence of side effects between the two groups except for diarrhea, which was more common in the gemeprost group. The incidence of fever was more common in the misoprostol group. It is concluded that vaginal misoprostol is more effective than gemeprost in termination of second trimester pregnancy.. The efficacies of vaginal gemeprost and vaginal misoprostol for the termination of second-trimester pregnancies were compared in a prospective, randomized trial conducted in Hong Kong, China. 140 women 16-40 years of age requesting pregnancy termination at gestational ages of 14-20 weeks were allocated to receive either 1 mg of gemeprost every 3 hours up to 5 doses (n = 70) or 400 mcg of misoprostol every 3 hours up to 5 doses (n = 70). 56 women (80.0%) in the misoprostol group and 41 (58.6%) in the gemeprost group aborted within 24 hours. In primigravidas, the rate of successful abortion was significantly higher in the misoprostol group (83.3%) than the gemeprost group (55.3%). There were no significant between-group differences in this rate for multigravid women. The median induction-abortion interval was significantly shorter in the misoprostol group (14.1 hours) than the gemeprost group (19.5 hours). Blood loss during the procedure was similar in both groups. Although there was no significant difference in the incidence of side effects, diarrhea was less common in misoprostol acceptors (24.3%) than in women who received gemeprost (40.0%). In addition to being more effective at inducing abortion, misoprostol is substantially less expensive than gemeprost and does not require refrigerated transport and storage facilities. Thus, misoprostol, with or without mifepristone, should be the drug of choice for termination of mid-trimester pregnancies. Further studies are needed, however, to determine the optimal dose and frequency of administration.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adolescent; Adult; Alprostadil; Diarrhea; Female; Fever; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, Second

Topics: Abortion, Induced; Adult; Female; Fetus; Fever; Humans; Misoprostol; Oxytocin; Pregnancy; Pregnancy Trimester, Second; Retrospective Studies

To characterise the occurrence of fever (≥38.0°C) after treatment for post-partum haemorrhage (PPH) with sublingual misoprostol 800 mcg in Latin America, where elevated rates of misoprostol's thermoregulatory effects and recipients' increased susceptibility to high fever have been documented.. A prospective observational study in hospitals in Argentina enrolled consenting women with atonic PPH after vaginal delivery, eligible to receive misoprostol. Corporal temperature was assessed at 30, 60, 90 and 120 min post-treatment; other effects were recorded. The incidence of high fever ≥ 40.0°C (primary outcome) was compared to the rate observed previously in Ecuador. Logistic regressions were performed to identify clinical and population-based predictors of misoprostol-induced fever.. Transient shivering and fever were experienced by 75.5% (37/49) of treated participants and described as acceptable by three-quarters of women interviewed (35/47). The high fever rate was 12.2% (6/49), [95% Confidence Interval (CI) 4.6, 24.8], compared to Ecuador's rate following misoprostol treatment (35.6% (58/163) [95% CI 28.3, 43.5], P = 0.002). Significant predictors of misoprostol-induced fever (model dependent) were as follows: pre-delivery haemoglobin < 11.0g/dl, rapid placental expulsion, and higher age of the woman. No serious outcomes were reported prior to discharge.. Misoprostol to treat PPH in Argentina resulted in a significantly lower rate of high fever than in Ecuador, although both are notably higher than rates seen elsewhere. A greater understanding of misoprostol's side effects and factors involved in their occurrence, including genetics, will help alleviate concerns. The onset of shivering may be the simplest way to know if fever can also be expected.. Caractériser la survenue de fièvre (≥ 38,0°C) après traitement d'une hémorragie post-partum (HPP) avec du misoprostol sublingual à 800 mcg en Amérique latine, où des taux élevés d'effets thermorégulateurs du misoprostol et une sensibilité accrue des receveurs à une forte fièvre ont été documentés. MÉTHODES: Une étude observationnelle prospective dans des hôpitaux en Argentine a recruté des femmes consentantes atteintes d'HPP atonique après un accouchement vaginal éligibles pour recevoir du misoprostol. La température corporelle a été évaluée 30, 60, 90 et 120 minutes après le traitement; d'autres effets ont été enregistrés. L'incidence d'une fièvre élevée ≥40,0°C (critère principal) a été comparée au taux observé précédemment en Equateur. Des régressions logistiques ont été effectuées pour identifier les prédicteurs cliniques et ceux basés sur la population de la fièvre induite par le misoprostol . RÉSULTATS: Des frissons transitoires et de la fièvre ont été ressentis par 75% (37/49) des participantes traitées et décrits comme acceptables par les trois quarts des femmes interrogées (35/47). Le taux de fièvre élevé était de 12% (6/49), [intervalle de confiance (IC) à 95%: 4,6, 24,8] contre 35,6% en Equateur après traitement au misoprostol (58/163) [IC95%: 28,3, 43,5], p = 0,002). Les prédicteurs significatifs de la fièvre induite par le misoprostol (selon le modèle) étaient: hémoglobine avant l'accouchement <11,0 g/dL, expulsion placentaire rapide et âge plus élevé de la femme. Aucun résultat sévère n'a été signalé avant le sortie d’hôpital.. Le misoprostol pour traiter l'HPP en Argentine a entraîné un taux de fièvre élevée significativement plus bas qu'en Equateur, bien que les taux dans les deux pays soient notablement plus élevés que les taux observés ailleurs. Une meilleure compréhension des effets secondaires du misoprostol et des facteurs impliqués dans leur apparition, y compris la génétique, aidera à atténuer les inquiétudes. L'apparition de frissons peut être le moyen le plus simple de savoir si l'on peut également s'attendre à de la fièvre.

Topics: Administration, Sublingual; Adolescent; Adult; Argentina; Ecuador; Female; Fever; Humans; Incidence; Misoprostol; Postpartum Hemorrhage; Prospective Studies; Racial Groups; Socioeconomic Factors; Young Adult

Misoprostol has a wide range of applications in obstetrics and gynaecology. It is widely recommended by WHO, FIGO and ACOG for the treatment of postpartum haemorrhage due to it safety and cost-effectiveness. However, usage might be associated to hyperpyrexia and shivering.. We present a 30 year old Cameroonian female gravida 1 para 1 who had a vaginal delivery at 40 weeks of gestation complicated by primary postpartum haemorrhage (PPH). PPH was managed by sublingual misoprostol that induced shivering and hyperpyrexia managed successfully with paracetamol and cooling.. The occurrence of fever and shivering should be kept in mind when administering misoprostol for PPH.

Topics: Administration, Sublingual; Adult; Female; Fever; Humans; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy

Fever is a well-known side effect of misoprostol, but clinically difficult to distinguish from an intra uterine infection. The aim of this study was to determine the incidence of fever in terminations of pregnancy (TOP) using misoprostol and to evaluate fever as indication of intra uterine infection.. A retrospective cohort study was performed. Consecutive second trimester TOP with misoprostol between January 2008 and October 2012 were selected. We included 403 cases and determined the incidence of fever. To examine intra uterine infection as plausible cause of fever, pathological examination reports of placentas were reviewed for signs of infections.. The incidence of fever was 42%. Logistic regression showed a dose dependent association between dosage misoprostol and degree of fever (OR 1.86; 95% CI: 1.3-2.7). There was no association between fever and epidural analgesia. Fever has a sensitivity of 55% and a specificity of 58% as a marker of intra uterine infection. The positive predictive value of fever for an intra uterine infection is 4% and the negative predictive value is 98%.. Administration of misoprostol for the indication TOP is strongly associated with fever during labor. Fever is a poor predictor of intra uterine infection in the context of TOP.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Female; Fever; Humans; Incidence; Logistic Models; Misoprostol; Netherlands; Predictive Value of Tests; Pregnancy; Pregnancy Trimester, Second; Puerperal Infection; Retrospective Studies; Sensitivity and Specificity; Uterine Diseases

Misoprostol, a synthetic prostaglandin E1 analog, is commonly used for treatment and prevention of postpartum hemorrhage. Known side effects include transient hyperthermia, chills, nausea, vomiting, and diarrhea.. After a precipitous vaginal delivery complicated by postpartum hemorrhage (600-mL blood loss), a healthy 21-year-old multiparous patient received 800 micrograms rectal misoprostol. Within 30 minutes, she developed rigors, severe hyperthermia (41.5°C [106.7°F]), tachycardia (170s), and transient encephalopathy. Antibiotics and a cooling protocol were initiated in the intensive care unit. Her abnormal vital signs resolved 7-8 hours later. Extensive workup was negative.. It is important to consider misoprostol toxicity in postpartum hyperthermia, rigors, and tachycardia. Misoprostol should be used judiciously given a lack of evidence for its effectiveness and its potential for serious side effects.

Topics: Administration, Rectal; Diagnosis, Differential; Female; Fever; Humans; Misoprostol; Oxytocics; Postpartum Hemorrhage; Pregnancy; Young Adult

Misoprostol, a prostaglandin analogue used for the treatment of postpartum hemorrhage and termination of pregnancy, can cause high fevers. Genetic susceptibility may play a role in misoprostol-induced fever.. Body temperature of women treated with misoprostol for termination of pregnancy in the UK (n = 107) and for postpartum hemorrhage in Ecuador (n = 50) was measured. Genotyping for 33 single nucleotide polymorphisms in 15 candidate genes was performed. Additionally, we investigated the transport of radiolabeled misoprostol acid across biological membranes in vitro.. The ABCC4 single nucleotide polymorphism rs11568658 was associated with misoprostol-induced fever. Misoprostol acid was transported across a blood-brain barrier model by MRP4 and SLCO1B1.. Genetic variability in ABCC4 may contribute to misoprostol-induced fever in pregnant women. Original submitted 21 January 2015; Revision submitted 24 April 2015.

Topics: Abortifacient Agents, Nonsteroidal; Adult; Blood-Brain Barrier; Body Temperature; Cell Line; Female; Fever; Genetic Predisposition to Disease; Genotype; Humans; Latin America; Liver-Specific Organic Anion Transporter 1; Misoprostol; Multidrug Resistance-Associated Proteins; Organic Anion Transporters; Polymorphism, Genetic; Polymorphism, Single Nucleotide; Postoperative Hemorrhage; Pregnancy; White People

Research on medical abortion has been conducted in Hong Kong since the 1990s. It was not until 2011 that the first-trimester medical abortion service was launched. Mifepristone was registered in Hong Kong in April 2014 and all institutions that are listed in the Gazette as a provider for legal abortion can purchase mifepristone from the local provider. This article aimed to share our 3-year experience of this service with the local medical community. Our current protocol is safe and effective, and advocates 200-mg mifepristone and 400-µg sublingual misoprostol 24 to 48 hours later, followed by a second dose of 400-µg sublingual misoprostol 4 hours later if the patient does not respond. The complete abortion rate is 97.0% and ongoing pregnancy rate is 0.4%. Some minor side-effects have been reported and include diarrhoea, fever, abdominal pain, and allergy. There have been no serious adverse events such as heavy bleeding requiring transfusion, anaphylactic reaction, septicaemia, or death.

Topics: Abdominal Pain; Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adolescent; Adult; Clinical Protocols; Diarrhea; Drug Hypersensitivity; Female; Fever; Hong Kong; Humans; Middle Aged; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Treatment Failure; Young Adult

Shivering and fever are common side effects of misoprostol. An unexpectedly high rate of fever above 40°C was documented among Ecuadorian women given treatment with 800mcg of sublingual misoprostol to manage postpartum hemorrhage (PPH) (36%). Much lower rates have been reported elsewhere (0-9%).. From February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine whether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (≥40°C). Rates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in Ecuador following PPH treatment with 800mcg sublingual misoprostol.. The 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50; 16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the 600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases of delirium/altered sensorium were reported with the 600mcg dose and women's assessment of severity/tolerability of shivering and fever was better with the lower dose.. 600mcg sublingual misoprostol was found to decrease the occurrence of high fever among Ecuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this treatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other populations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following sublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger trials to confirm the efficacy of lower dosages may be justified.. Clinical trials.gov, Registry No. NCT01080846.

Topics: Administration, Sublingual; Adolescent; Adult; Dose-Response Relationship, Drug; Female; Fever; Humans; Misoprostol; Pilot Projects; Postpartum Hemorrhage; Pregnancy; Shivering; Uterine Inertia; Young Adult

To explore what triggers an elevated body temperature of > or =40.0 degrees C in some women given misoprostol, a prostaglandin E1 analogue, for postpartum haemorrhage (PPH).. Post hoc analysis.. One tertiary-level hospital in Quito, Ecuador.. A cohort of 58 women with a fever of above 40 degrees C following treatment with sublingual misoprostol (800 micrograms) for PPH.. Side effects were documented for 163 Ecuadorian women given sublingual misoprostol to treat their PPH. Women's body temperatures were measured, and if they had a fever of > or =40.0 degrees C, measurements were taken hourly until the fever subsided. Temperature trends were analysed, and the possible physiological mechanisms by which postpartum misoprostol produces a high fever were explored.. The onset, duration, peak temperatures, and treatments administered for cases with a high fever.. Fifty-eight of 163 women (35.6%) treated with misoprostol experienced a fever of > or =40.0 degrees C. High fevers followed a predictable pattern, often preceded by moderate/severe shivering within 20 minutes of treatment. Body temperatures peaked 1-2 hours post-treatment, and gradually declined over 3 hours. Fevers were transient and did not lead to any hospitalisation. Baseline characteristics were comparable among women who did and did not develop a high fever, except for known previous PPH and time to placental expulsion.. An unexpectedly high rate of elevated body temperature of > or =40.0 degrees C was documented in Ecuador following sublingually administered misoprostol. It is unclear why temperatures > or =40.0 degrees C occurred with a greater frequency in Ecuador than in other study populations using similar treatment regimens for PPH. Pharmacogenetic studies may shed further light on variations in individuals' responses to misoprostol.

Topics: Administration, Sublingual; Adult; Ecuador; Female; Fever; Humans; Length of Stay; Misoprostol; Oxytocics; Patient Satisfaction; Postpartum Hemorrhage; Shivering; Young Adult

To assess the effectiveness of intravaginal misoprostol for second trimester uterine evacuation, we studied 70 women with singleton pregnancies complicated by fetal malformation or dead fetuses. Participants received 200 microg misoprostol administered at 4-hour intervals. Gestations with dead fetuses had a shorter induction-abortion interval [14.2 hours, standard deviation (SD) 4.3] than those with live, malformed fetuses (20.2 hours, SD 7.3) (P< 0.001). The abortion rate was significantly higher for gestations with dead fetuses (92.1%) than those with live, malformed fetuses (68.8%) (P< 0.05). There were no major complications and no significant difference in the incidence of side-effects. All women aborted within 38 hours. Administration of misoprostol is an effective clinical method to terminate second trimester, complicated pregnancy.

Topics: Abdominal Pain; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Congenital Abnormalities; Diarrhea; Drug Administration Schedule; Female; Fetal Death; Fever; Gestational Age; Hospitals, Military; Humans; Jordan; Misoprostol; Nausea; Parity; Postpartum Hemorrhage; Pregnancy; Pregnancy Trimester, Second; Time Factors; Treatment Outcome; Ultrasonography, Prenatal; Vomiting

Misoprostol is a prostaglandin E(1) analogue that has been used for medical abortion. We conducted this prospective study to compare the efficacy of vaginal misoprostol for abortion in women at a gestational age of <42 days and in women at a gestational age of 42-56 days.. A total of 160 women seeking medical termination of a pregnancy of <56 days were enrolled in the study. Medical termination was performed using 800 micro g of vaginal misoprostol, repeated every 24 h for a maximum of three doses.. The overall complete abortion rate was 91.3%. In group A (gestation <42 days) complete abortion occurred in 96.3% of women, whereas in group B (gestation = 42-56 days) complete abortion occurred in 86.3% of women (P < 0.025). The two groups did not differ significantly with respect to side-effects (incidence of pain, bleeding, nausea, diarrhoea, fever and headache). Women who had aborted successfully were significantly more satisfied with the method compared with women who did not (P < 0.001).. The vaginal misoprostol-alone regimen is highly effective for women seeking medical abortion of pregnancies of

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adolescent; Adult; Diarrhea; Female; Fever; Gestational Age; Headache; Humans; Misoprostol; Nausea; Pain; Patient Satisfaction; Pregnancy; Treatment Outcome; Uterine Hemorrhage

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Alprostadil; Body Temperature; Female; Fever; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, First; Retrospective Studies

To evaluate the efficacy of a regimen of vaginal misoprostol in causing the complete expulsion of first-trimester missed abortions, or alternatively dilating the cervix for surgical evacuation.. Seventy-four women with a transvaginal ultrasound diagnosis of a first-trimester missed abortion and no more than slight vaginal bleeding were consecutively enrolled. Misoprostol (600 microg) was administered vaginally and repeated 4 h later if necessary. Surgical evacuation was performed when complete expulsion was not documented on the ultrasound 10-12 h after treatment.. Complete medical evacuation occurred in 42 women (56.8%), 11 (14.9%) of which required only one dose. Seventy women (94.6%) experienced abdominal pain, 73 (98.6%) vaginal bleeding, 10 (13.5%) nausea, 4 (5.4%) vomiting, 5 (6.8%) diarrhea, and 4 (5.4%) transient hyperthermia. There was one case of heavy vaginal bleeding requiring emergency surgical evacuation, and one re-admission for incomplete abortion at 30 days. All but 4 (5.4%) women had permeable cervices at the time of surgery.. The described regimen of vaginal misoprostol is safe and reasonably effective in inducing complete evacuation in missed abortions. When this does not occur, it almost always provides adequate cervical dilatation for surgery.

Topics: Abdominal Pain; Abortifacient Agents, Nonsteroidal; Abortion, Missed; Administration, Intravaginal; Adolescent; Adult; Diarrhea; Drug Administration Schedule; Female; Fever; Humans; Misoprostol; Nausea; Pregnancy; Pregnancy Trimester, First; Prospective Studies; Time Factors; Ultrasonography; Uterine Hemorrhage; Vomiting

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Therapeutic; Administration, Intravaginal; Adult; Cervical Ripening; Female; Fever; Humans; Misoprostol; Pregnancy

Topics: Administration, Oral; Adult; Female; Fever; Humans; Misoprostol; Postpartum Hemorrhage; Postpartum Period

Topics: Female; Fever; Humans; Liver Cirrhosis; Middle Aged; Misoprostol