misoprostol and Pain

Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks' gestation.  OBJECTIVES: Primary objective To determine if there is evidence of superiority of any particular pain relief regimen in the management of combination medical abortion (mifepristone + misoprostol) under 14 weeks' gestation (i.e. up to 13 + 6 weeks or 97 days). Secondary objectives To compare the rate of gastrointestinal side effects resulting from different methods of analgesia To compare the rate of complete abortion resulting from different methods of analgesia during medical abortion To determine if the induction-to-abortion interval is associated with different methods of analgesia To determine if any method of analgesia is associated with unscheduled contact with the care provider in relation to pain.. On 21 August 2019 we searched CENTRAL, MEDLINE, Embase, CINAHL, LILACs, PsycINFO, the World Health Organization International Clinical Trials Registry and ClinicalTrials.gov together with reference checking and handsearching of conference abstracts of relevant learned societies and professional organisations to identify further studies.. We included randomised controlled trials (RCTs) and observational studies (non-randomised studies of interventions (NRSIs)) of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks' gestation.. Two review authors (JRW and MA) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion with a third and fourth author as required (CM and SC). Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked for accuracy. We assessed the certainty of the evidence using the GRADE approach.. We included four RCTs and one NRSI. Due to the heterogeneity of study designs, interventions and outcome reporting, we were unable to perform meta-analysis for any of the primary or secondary outcomes in this review. Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600 mg likely reduces the pain score when compared to a dose of paracetamol 2000 mg (mean difference (MD) 2.26 out of 10 lower, 95% confidence interval (CI) 3.00 to 1.52 lower; 1 RCT 108 women; moderate-certainty evidence). There may be little to no difference in pain score when comparing pregabalin 300 mg with placebo (MD 0.5 out of 10 lower, 95% CI 1.41 lower to 0.41 higher; 1 RCT, 107 women; low-certainty evidence).  There may be little to no difference in pain score when comparing ibuprofen 800 mg with placebo (MD 1.4 out of 10 lower, 95% CI 3.33 lower to 0.53 higher; 1 RCT, 61 women; low-certainty evidence). Ambulation or non-ambulation during medical abortion treatment may have little to no effect on pain score, but the evidence is very uncertain (MD 0.1 out of 5 higher, 95% CI 0.26 lower to 0.46 higher; 1 NRSI, 130 women; very low-certainty evidence). There may be little to no difference in pain score when comparing therapeutic versus prophylactic administration of ibuprofen 800 mg (MD 0.2 out of 10 higher, 95% CI 0.41 lower to 0.81 higher; 1 RCT, 228 women; low-certainty evidence).   Other outcomes of interest were reported inconsistently across studies. Where these outcomes were reported, there was no evidence of difference in incidence of gastrointestinal side effects, complete abortion rate, interval between misoprostol administration to pregnancy expulsion, unscheduled contact with a care provider, patient satisfaction with analgesia regimen nor patient satisfaction with abortion experience overall. However, the certainty of evidence was very low to low.. The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600 mg was shown to be effective, and it was less certain whether 800 mg was effective. Paracetamol 2000 mg does not improve pain scores as much as ibuprofen 1600 mg, however its use does not appear to cause greater frequency of side effects or reduce the success of the abortion. A single dose of pregabalin 300 mg does not affect pain scores during medical abortion, but like paracetamol, does not appear to cause harm. Ambulation or non-ambulation during the medical abortion procedure does not appear to affect pain scores, outcomes, or duration of treatment and so women can be advised to mobilise or not, as they wish. The majority of outcomes in this review had low- to very low-certainty evidence, primarily due to small sample sizes and two studies at high risk of bias. High-quality, large-scale RCT research is needed for pain management during medical abortion at gestations less than 14 weeks. Consistent recording of pain with a validated measure would be of value to the field going forward.

Topics: Abortion, Induced; Abortion, Spontaneous; Acetaminophen; Female; Humans; Ibuprofen; Mifepristone; Misoprostol; Pain; Pain Management; Pregabalin; Pregnancy

Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks' gestation.. We conducted our search in August 2019 and included randomized controlled trials (RCT) and observational studies of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks' gestation.. We included four RCTs and one observational study. Due to the heterogeneity of study designs, interventions and outcome reporting, meta-analysis was not possible. Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600mg likely reduces the pain score when compared to a dose of paracetamol 2000mg (MD 2.26/10 [CI 3-1.52 lower]). For other interventions (pregabalin 300mg vs placebo; ibuprofen 800mg vs placebo; therapeutic vs prophylactic administration of ibuprofen 800mg; ambulation vs non-ambulation during treatment) there appeared to be little to no difference with comparator.. The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600mg was shown to be effective and it was less certain whether 800mg was effective.

Topics: Female; Humans; Ibuprofen; Mifepristone; Misoprostol; Observational Studies as Topic; Pain; Pain Management; Pregnancy

Potential barriers to intrauterine device (IUD) use include provider concern about difficult insertion, particularly for nulliparous women.. This study aims to evaluate the evidence on the effectiveness of medications to ease IUD insertion on provider outcomes (i.e., ease of insertion, need for adjunctive insertion measures, insertion success).. We searched the PubMed database for peer-reviewed articles published in any language from database inception through February 2016.. We included randomized controlled trials (RCTs) that examined medications to ease interval insertion of levonorgestrel-releasing IUDs and copper T IUDs.. From 1855 articles, we identified 15 RCTs that met our inclusion criteria. Most evidence suggested that misoprostol did not improve provider ease of insertion, reduce the need for adjunctive insertion measures or improve insertion success among general samples of women seeking an IUD (evidence Level I, good to fair). However, one RCT found significantly higher insertion success among women receiving misoprostol prior to a second IUD insertion attempt after failed attempt versus placebo (evidence Level I, good). Two RCTs on 2% intracervical lidocaine as a topical gel or injection suggested no positive effect on provider ease of insertion (evidence Level I, good to poor), and one RCT on diclofenac plus 2% intracervical lidocaine as a topical gel suggested no positive effect on provider ease of insertion (evidence Level I, good). Limited evidence from two RCTs on nitric oxide donors, specifically nitroprusside or nitroglycerin gel, suggested no positive effect on provider ease of insertion or need for adjunctive insertion measures (evidence Level I, fair).. Overall, most studies found no significant differences between women receiving interventions to ease IUD insertion versus controls. Among women with a recent failed insertion who underwent a second insertion attempt, one RCT found improved insertion success among women using misoprostol versus placebo.

Topics: Equipment Safety; Female; Humans; Intrauterine Devices; Misoprostol; Nitroglycerin; Nitroprusside; Pain; Randomized Controlled Trials as Topic

To examine rates of intrauterine device (IUD) insertion failure with and without prior misoprostol administration. Additional outcomes included difficulty of insertion, subjective pain, expulsion, and complications.. Systematic searches were performed in PubMed MEDLINE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Cumulative Index to Nursing and Allied Health Literature for articles with the following keywords: "misoprostol," "intrauterine devices," and "IUDs.". A total of 161 unique results were retrieved. Titles, abstracts, and full-text articles were independently screened twice by two reviewers for content and relevance. Quality assessment was performed using previously established criteria. After screening and quality assessment, nine randomized controlled trials (RCTs) were obtained for inclusion. Six articles were designated high quality and three were designated low quality.. Six of six RCTs examining IUD insertion failure with misoprostol revealed no difference in this measure. Of nine RCTs examining difficulty of IUD insertion with misoprostol, seven revealed no difference in this measure and two revealed decreased difficulty of insertion with misoprostol administration. Of nine RCTs examining pain with IUD insertion, seven revealed no difference in pain measurement scores, one revealed increased pain with misoprostol administration, and one revealed decreased pain with misoprostol administration. Five studies examining rates of expulsion and two studies examining complications of IUD insertion revealed no difference in this measure.. No data support routine administration of misoprostol before IUD insertion. Success of insertion is high even among nulliparous women, and good-quality data do not demonstrate that misoprostol use increases success. These data similarly reveal no differences in difficulty of insertion, pain with insertion, or expulsion with prior administration of misoprostol. However, data for several outcomes are limited by lack of power.

Topics: Abortifacient Agents, Nonsteroidal; Catheterization, Peripheral; Female; Humans; Intrauterine Devices; Misoprostol; Pain; Pregnancy; Randomized Controlled Trials as Topic

Fear of pain during insertion of intrauterine contraception (IUC) is a barrier to use of this method. IUC includes copper-containing intrauterine devices and levonorgestrel-releasing intrauterine systems. Interventions for pain control during IUC insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol.. To review randomized controlled trials (RCTs) of interventions for reducing IUC insertion-related pain. We searched for trials in CENTRAL, MEDLINE, EMBASE, POPLINE, ClinicalTrials.gov, and ICTRP. The most recent search was 22 June 2015. We examined reference lists of pertinent articles. For the initial review, we wrote to investigators to find other published or unpublished trials.. We included RCTs that evaluated an intervention for preventing IUC insertion-related pain. The comparison could have been a placebo, no intervention, or another active intervention. The primary outcomes were self-reported pain at tenaculum placement, during IUC insertion, and after IUC insertion (up to six hours).. Two authors extracted data from eligible trials. For dichotomous variables, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. In meta-analysis of trials with different measurement scales, we used the standardized mean difference (SMD).. We included 33 trials with 5710 participants total; 29 were published from 2010 to 2015. Studies examined lidocaine, misoprostol, NSAIDs, and other interventions. Here we synthesize results from trials with sufficient outcome data and moderate- or high-quality evidence.For lidocaine, meta-analysis showed topical 2% gel had no effect on pain at tenaculum placement (two trials) or on pain during IUC insertion (three trials). Other formulations were effective compared with placebo in individual trials. Mean score for IUC-insertion pain was lower with lidocaine and prilocaine cream (MD -1.96, 95% CI -3.00 to -0.92). Among nulliparous women, topical 4% formulation showed lower scores for IUC-insertion pain assessed within 10 minutes (MD -15.90, 95% CI -22.77 to -9.03) and at 30 minutes later (MD -11.10, 95% CI -19.05 to -3.15). Among parous women, IUC-insertion pain was lower with 10% spray (median 1.00 versus 3.00). Compared with no intervention, pain at tenaculum placement was lower with 1% paracervical block (median 12 versus 28).For misoprostol, meta-analysis showed a higher mean score for IUC insertion compared with placebo (SMD 0.27, 95% CI 0.07 to 0.46; four studies). In meta-analysis, cramping was more likely with misoprostol (OR 2.64, 95% CI 1.46 to 4.76; four studies). A trial with nulliparous women found a higher score for IUC-insertion pain with misoprostol (median 46 versus 34). Pain before leaving the clinic was higher for misoprostol in two trials with nulliparous women (MD 7.60, 95% CI 6.48 to 8.72; medians 35.5 versus 20.5). In one trial with nulliparous women, moderate or severe pain at IUC insertion was less likely with misoprostol (OR 0.30, 95% CI 0.16 to 0.55). In the same trial, the misoprostol group was more likely to rate the experience favorably. Within two trials of misoprostol plus diclofenac, shivering, headache, or abdominal pain were more likely with misoprostol. Participants had no vaginal delivery. One trial showed the misoprostol group less likely to choose or recommend the treatment.Among multiparous women, mean score for IUC-insertion pain was lower for tramadol 50 mg versus naproxen 550 mg (MD -0.63, 95% CI -0.94 to -0.32) and for naproxen versus placebo (MD -1.94, 95% CI -2.35 to -1.53). The naproxen group was less likely than the placebo group to report the insertion experience as unpleasant and not want the medication in the future. An older trial showed repeated doses of naproxen 300 mg led to lower pain scores at one ho. Nearly all trials used modern IUC. Most effectiveness evidence was of moderate quality, having come from single trials. Lidocaine 2% gel, misoprostol, and most NSAIDs did not help reduce pain. Some lidocaine formulations, tramadol, and naproxen had some effect on reducing IUC insertion-related pain in specific groups. The ineffective interventions do not need further research.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Ibuprofen; Intrauterine Devices; Lidocaine; Misoprostol; Naproxen; Oxytocics; Pain; Prilocaine; Randomized Controlled Trials as Topic

Several randomised controlled trials have been published in the last few years which evaluated the efficacy of various analgesics in reducing visual analogue (VAS) pain scores during intrauterine device (IUD) placement. Their results seem to be conflicting and inconclusive.. We searched Medline (1966-2013), Scopus (2004-2013), Clinicaltrials.org (1997-2013), Popline (1973-2013), Cochrane CENTRAL (1999-2013) and Google Scholar (2004-2013) engines for published randomised controlled trials, as well as the reference lists from all electronically retrieved studies.. Thirteen studies, involving 1353 women, were finally included in the present meta-analysis. Among the products used, and with respect to their mode of delivery, only paracervical lidocaine was effective in producing lower VAS pain scores related to tenaculum placement (mean difference [MD]: - 20.54; 95% confidence interval [CI]: - 39.92, - 1.15) and IUD insertion (MD: - 28.99; 95% CI: - 53.14, - 4.84). Misoprostol produced higher VAS pain scores for the immediate post-insertion period (MD: 2.83; 95% CI: - 0.79, 6.45) and it caused various side effects.. Paracervical administration of lidocaine prior to IUD insertion reduces VAS pain scores. In view of the small number of studies assessing its efficacy further studies should confirm our findings.

Topics: Analgesia; Anesthetics, Local; Female; Humans; Intrauterine Devices; Lidocaine; Misoprostol; Oxytocics; Pain; Pain Measurement; Prosthesis Implantation; Randomized Controlled Trials as Topic

Medical abortion is a safe, convenient, and effective method for terminating an early unintended pregnancy. Medical abortion can be performed up to 63 days from the last menstrual period and may even be used up to 70 days for women who prefer medical abortion over surgical abortion. Counseling on the adverse effects and expectations for medical abortion is critical to success. Medical abortion can be performed in a clinic without special equipment, and it is perceived as more "natural" than a surgical abortion by many women. Follow-up for medical abortion can be simplified to include only serum human chorionic gonadotropin measurements when necessary, although obtaining an ultrasound remains the criterion standard. Pain associated with medical abortion is best treated with nonsteroidal anti-inflammatory medications, possibly in combination with opioid analgesics. Medical abortion can contribute to continuity of care for women who wish to remain with their primary care providers for management of their abortion.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Aftercare; Chorionic Gonadotropin; Counseling; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Pregnancy; Ultrasonography, Prenatal

To evaluate pain and other early adverse events associated with different regimens of medical abortion up to nine weeks of amenorrhoea.. The literature was searched for comparative studies of medical abortion using mifepristone followed by the prostaglandin analogue misoprostol. Publications, which included pain assessment were further analysed.. Of the 1459 publications on medical abortion identified, only 23 comparative, prospective trials corresponded to the inclusion criteria. Patients in these studies received different dosages of mifepristone in combination with different dosages of misoprostol administered via diverse routes or at various intervals. Information on pain level was reported in 12/23 papers (52%), information regarding systematic administration of analgesics in 12/23 articles (52%) and information concerning analgesia used was available for only 10/23 studies (43%).. Neither pain nor its treatment are systematically reported in clinical trials of medical abortion; this shortcoming reflects a neglect of the individual pain perception. When data are mentioned, they are too inconsistent to allow for any comparison between different treatment protocols. Standardised evaluation of pain is needed and the correlation between the dosage of misoprostol and the intensity of pain must be assessed in future studies.

Topics: Abortion, Induced; Adult; Analgesics; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Pain; Pain Management; Pain Measurement; Pregnancy; Prospective Studies

Studies examining the use of pharmaceutical (prostaglandins, antiprogestogens) and mechanical (osmotic dilators) dilatation of the cervix before hysteroscopy under general anaesthesia have produced conflicting results regarding their effect on cervical dilatation and trauma during the procedure.. To compare the effect on pain and need for cervical dilatation of various methods of cervical preparation before outpatient hysteroscopy.. MEDLINE, EMBASE and CINAHL were searched using a combination of the keywords 'hysteroscopy', 'vaginoscopy', 'cervical ripening', 'laminaria', 'progest*', 'prostaglandin', 'oestrogen''cervical preparation' and their associated Medical Subject Headings The Cochrane Library was searched using the keywords 'hysteroscopy' and 'cervical'. There were no limits or filters placed on the searches.. Randomised controlled trials that examined women undergoing outpatient hysteroscopy, where the intervention was the use of cervical preparation versus a control or placebo and the outcome was pain assessment.. Two reviewers independently selected trials. Data were extracted on pain, the effect on dilatation, adverse effects, trauma and feasibility. Data regarding pain and cervical dilatation were unsuitable for meta-analysis. Meta-analyses were performed for adverse effects and feasibility using the random effects models to calculate the Peto odds ratio.. From 585 abstracts, six studies were selected for inclusion in the systematic review. The results suggest that there may be a benefit of using prostaglandins for postmenopausal women; however, there is no high-quality evidence that giving misoprostol before outpatient hysteroscopy reduces the pain experienced by women of reproductive age. There is some evidence that prostaglandins reduce the force and requirement for dilatation of the cervix beyond 5 mm.. There is no evidence to recommend the routine administration of mifepristone or misoprostol to women before outpatient hysteroscopy. Cervical priming with vaginal prostaglandins may be considered in postmenopausal women if using hysteroscopic systems >5 mm in diameter.

Topics: Ambulatory Care; Dilatation; Female; Hormone Antagonists; Humans; Hysteroscopy; Mifepristone; Misoprostol; Pain; Premedication

Fear of pain during intrauterine device (IUD) insertion is a barrier to use of this contraceptive method. Interventions for pain during IUD insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol.. To review all randomized controlled trials that have evaluated a treatment for IUD insertion-related pain.. We searched the computerized databases MEDLINE, POPLINE, CENTRAL, and EMBASE for relevant trials. We also examined reference lists of pertinent articles and wrote to known investigators for information about other published or unpublished trials.. We included all randomized controlled trials in any language that evaluated a treatment for IUD insertion-related pain. The intervention could be compared to a placebo or another active intervention.. Two authors independently abstracted data from relevant trials and data were entered into RevMan 5.0 for analysis. For dichotomous variables, the Peto odds ratios with 95% confidence intervals was calculated. For continuous variables, the mean differences with 95% confidence interval was computed.. Four trials met the inclusion criteria; the total number of participants was 2204. Nonsteroidal anti-inflammatory drugs of varying types and doses were not effective for reducing pain during IUD insertion. Misoprostol for cervical ripening did not reduce pain with IUD insertion in nulliparous women. Two trials evaluated pain that occurs after IUD insertion using nonsteroidal anti-inflammatory drugs. In one trial, naproxen taken prior to IUD insertion was effective in reducing pain compared with placebo in the first two hours after IUD insertion in mostly nulliparous women. However, this trial utilized the Dalkon Shield, an IUD with a wider diameter than modern IUDs. In another trial, ibuprofen 600 mg taken before IUD insertion did not show evidence of an effect on pain four to six hours after IUD insertion.. No interventions that have been properly evaluated reduce pain during or after IUD insertion. One poorly controlled trial suggested that topical lidocaine gel may reduce insertion-related pain and warrants further investigation.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Ibuprofen; Intrauterine Devices; Misoprostol; Naproxen; Oxytocics; Pain; Randomized Controlled Trials as Topic

To analyze and evaluate the acceptability of mifepristone compatible with misoprostone versus conventional surgical abortion among women under unwanted early pregnancy, so as to help the unexpected pregnant women to choose the satisfactory abortion, and to provide the evidence for clinicians to make a proper clinical decision.. Six medical databases were searched, including MEDLINE, EMBASE, Cochrane library, CBMdisc, CNKI and VIP, together with twelve journals hand-searched, and references of included studies additionally searched. Two qualified reviewers reviewed the original articles, evaluating qualities of articles, and extracting data independently. After heterogeneity test, the data was pooled using Revman software if capable, or descriptive analysis was applied.. In total, nine original clinical controlled trials were included, containing 3565 cases. Before abortion, more unwanted pregnant women chose the medical abortion because they believed medical abortion was less painful than surgical abortion (OR = 466.51, 95% CI: 91.37 - 2381.88), but medical abortion was less time-consuming than surgical abortion (OR = 0.02, 95% CI: 0.01 - 0.06). After abortion, satisfaction with medical abortion was similar to that with surgical abortion, with insignificant difference (P = 0.89). However, second choice and recommendation rates of medical abortion were much higher than those of surgical abortion with OR and 95% CI as 2.72, 2.13 - 3.47 and 4.19, 2.16 - 11.16, respectively.. Medical abortion was less painful than surgical abortion and the rate of second choice and recommendation to others were all also higher than those of surgical abortion. However, the process of medical abortion was not as quick as surgical abortion but the satifacation of both methods seemed similar. Therefore, the two artificial abortion methods were not recommended to replace each other at the present time.

Topics: Abortifacient Agents; Abortion, Induced; Choice Behavior; Controlled Clinical Trials as Topic; Female; Humans; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Pregnancy, Unwanted

Topics: Administration, Oral; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Dose-Response Relationship, Drug; Humans; Misoprostol; Musculoskeletal Diseases; Osteoarthritis; Pain; Peptic Ulcer; Randomized Controlled Trials as Topic; Risk; Treatment Outcome

Topics: Administration, Oral; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Humans; Misoprostol; Musculoskeletal Diseases; Osteoarthritis; Pain; Peptic Ulcer

Data from four double-blind studies of the treatment of patients with rheumatoid arthritis or osteoarthritis were combined. For 4 to 12 weeks, 747 patients received Arthrotec, a combination of 50 mg of diclofenac and 200 micrograms of misoprostol, and 754 patients received 50 mg of diclofenac; the drugs were given twice or three times daily. The five most commonly reported adverse events were abdominal pain by 23.2% of the diclofenac/misoprostol patients and 19.8% of the diclofenac patients; diarrhea by 19.9% and 11.3%; nausea by 11.8% and 6.5%; dyspepsia by 11.2% and 7.8%; and flatulence by 8.0% and 3.1%. Other adverse events, reported by similar proportions of both treatment groups, included headache, gastritis, dizziness, vomiting, and constipation. In the diclofenac/misoprostol-treated patients, the abdominal pain and diarrhea were rated mild in 30.6% and 24.3%, moderate in 49.1% and 51.4%, and severe in 20.2% and 24.3%. Serious adverse events occurred in eight of the diclofenac/misoprostol-treated patients and in 13 of the diclofenac-treated patients; 12.6% and 10.1%, respectively, were withdrawn from the study because of adverse events. Results of laboratory tests of hepatic and renal function were similar in the two treatment groups.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Arthritis, Rheumatoid; Constipation; Diarrhea; Diclofenac; Dizziness; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Misoprostol; Osteoarthritis; Pain; Vomiting

Recent findings suggest that the protective role that misoprostol exerts in the gastrointestinal tract against nonsteroidal anti-inflammatory drug (NSAID) damage may be extended to a variety of other tissues and other noxious stimuli including those mediated by molecules such as interleukin 1 (IL-1), tumor necrosis factor (TNF), and endotoxin. The protective effects of misoprostol outside the gastrointestinal tract may involve prevention of triggering activities that would otherwise initiate a sequence of tissue damaging events. If this capacity of misoprostol to maintain homeostasis in a variety of settings is recognized, a cohesive pattern of action emerges. Numerous studies have shown that misoprostol is likely to act as a regulator within various cascades of immunological regulatory events. The in vitro and in vivo experimental data described in this paper suggest that the events which trigger episodes of pain and inflammation may be controllable by the administration of misoprostol. Mitigation of adverse effects of certain NSAIDs on renal function and cartilage metabolism has also been observed. Demonstration of this latter phenomenon in the clinical setting will greatly benefit the patient if it is shown to modify the arthritis disease process. The therapeutic applications of misoprostol beyond the gastrointestinal tract appear to be among the most interesting of therapeutic advances offered by any class of compound in the next decade. Because of the inflammatory and pain processes associated with arthritis disease progression, particular emphasis and confirmation through further clinical study should be placed on the potential effect of misoprostol on chondroprotection and synergy with NSAIDs.

Topics: Adjuvants, Immunologic; Arthritis; Bone Diseases; Cartilage; Homeostasis; Humans; Kidney; Misoprostol; Pain

To evaluate efficacy and satisfaction of dextromethorphan as a non-narcotic adjuvant to current analgesic regimens for medication abortion.. We conducted a randomized, double-blinded, placebo-controlled trial. We randomized eligible participants (N = 156) 1:1 to adjunctively take dextromethorphan (loading dose 60 mg and two subsequent 30 mg doses at 2 and 5 hours after misoprostol administration) or placebo combined with usual-care nonsteroidal anti-inflammatory medications ± opioids for pain. Participants reported pain scores and satisfaction using a secure texting application at 2, 5, 8, and 24 hours after misoprostol administration. Our primary outcome was worst pain score and total analgesic use.. Baseline demographics of enrolled participants were similar between randomization arms. Worst pain scores for participants receiving dextromethorphan versus placebo (8.0 vs 7.0, p = 0.06) did not differ. Total milligram usage of ibuprofen (800 mg vs 610 mg, p =.62), acetaminophen (1000 mg vs 1300 mg, p = 0.62), and opioids (10 mg vs 15 mg, p = 0.51) did not differ between the randomization groups. Participants randomized to placebo were significantly more likely to be satisfied with their pain control (91% vs 75%, p = 0.02).. Dextromethorphan used adjunctively with standard analgesics did not reduce pain associated with medication abortion. Participants who received dextromethorphan reported decreased satisfaction with their pain control.. Dextromethorphan used adjunctively with commonly used analgesic regimens did not reduce medication abortion associated pain. Many participants did not use analgesics as counseled, and nearly 25% used no analgesia during medication abortion.

Topics: Analgesics; Analgesics, Non-Narcotic; Analgesics, Opioid; Dextromethorphan; Double-Blind Method; Female; Humans; Misoprostol; Pain; Pain, Postoperative; Pregnancy

We aimed to characterize the current pain experience of patients completing an evidence-based mifepristone-misoprostol medication abortion regimen using real-time pain scores.. We collected real-time data on pain experienced by 54 women undergoing medication abortion using an evidence-based regimen of 200 mg mifepristone and 800 mcg buccal misoprostol. These women were enrolled in the placebo arm of a study on the effect of pregabalin for pain during medication abortion. All participants were dispensed ibuprofen and oxycodone/acetaminophen for analgesia. We assessed maximum pain experienced by participants on an 11-point numerical rating scale (NRS), duration of pain, and analgesic usage. Data was collected through electronic surveys sent via text message link at 6 specified points over 72 hours.. Of the 54 women randomized to the placebo group, 2 were lost to follow-up. Participants experienced a mean maximum pain score of 5.5 ± 2.2. The mean time to maximum pain was 3.7 ± 2.4 hours after misoprostol. By hour 12 after misoprostol, 60.8% of participants reported no pain, which increased to 76.9% at 24 hours and 82.0% at 72 hours. Participants reported median ibuprofen usage of 2 800 mg tablets and median oxycodone/acetaminophen usage of one-half of a 5/325mg tablet. Approximately 12.0% of participants reported taking zero ibuprofen tablets, and 50.0% reported no opioid usage during the study period.. Our real-time data collection demonstrated lower mean maximum experienced pain scores and shorter duration of pain than previously reported for medication abortion. Analgesic use was lower than previously described.. This updated characterization of pain experienced during an evidence-based medication abortion regimen may allow for better pain-related counseling, tailoring of opioid prescription practices, and improvement in patient satisfaction.

Topics: Abortion, Induced; Acetaminophen; Analgesics; Analgesics, Opioid; Female; Humans; Ibuprofen; Mifepristone; Misoprostol; Oxycodone; Pain; Pregnancy

To evaluate whether a synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening.. In an open-label, noninferiority randomized trial, pregnant women undergoing induction of labor at 37 weeks of gestation or more with Bishop scores less than 6 were randomized to either mechanical cervical dilation or oral misoprostol. Participants in the mechanical dilation group underwent insertion of synthetic osmotic cervical dilator rods, and those in the misoprostol group received up to six doses of 25 micrograms orally every 2 hours. After 12 hours of ripening, oxytocin was initiated, with artificial rupture of membranes. Management of labor was at the physician's discretion. The primary outcome was the proportion of women achieving vaginal delivery within 36 hours of initiation of study intervention. Secondary outcomes included increase in Bishop score, mode of delivery, induction-to-delivery interval, total length of hospital stay, and patient satisfaction. On the basis of a noninferiority margin of 10%, an expected primary outcome frequency of 65% for misoprostol and 71% for mechanical methods, and 85% power, a sample size of 306 participants was needed.. From November 2018 through January 2021, 307 women were randomized, with 151 evaluable participants in the synthetic osmotic cervical dilator group and 152 in the misoprostol group (there were four early withdrawals). The proportion of women achieving vaginal delivery within 36 hours was higher with mechanical cervical dilation compared with misoprostol (61.6% vs 59.2%), with an absolute difference of 2.4% (95% CI -9% to 13%), indicating noninferiority for the prespecified margin. No differences were noted in the mode of delivery. Tachysystole was more frequent in the misoprostol group (70 [46.4%] vs 35 [23.3%]; P=.01). Participants in the synthetic osmotic cervical dilator group reported better sleep, less unpleasant abdominal sensations, and lower pain scores (P<.05).. Synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. Advantages of synthetic osmotic cervical dilator include a better safety profile and patient satisfaction, less tachysystole, lower pain scores, and U.S. Food and Drug Administration approval.. ClinicalTrials.gov, NCT03670836.. Medicem Technology s.r.o., Czech Republic.

Topics: Administration, Intravaginal; Cervical Ripening; Dilatation; Dystocia; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pain; Pregnancy

To compare oxycodone administration via intravenous patient-controlled analgesia (IVPCA) vs on-demand administration during late-first- and second-trimester medically induced abortion.. A prospective randomized controlled study. We enrolled women between 64 to 128 days of gestation in the study between June 2016 and August 2018. Participants were randomized to receive oxycodone either via IVPCA or given on-demand orally, intramuscularly, or intravenously. Pain intensity and satisfaction with care were measured using the visual analogue scale (VAS, 0-100mm).. Altogether 99 participants were randomized: 48 in IVPCA group and 51 in on-demand group. Median gestational age was similar between groups (74 days [Interquartile range, IQR 69-81] in the IVPCA group vs 72 [69-80] in the control group, p = 0.587). Peak maximal pain was severe in both groups (median pain VAS was 62 [IQR 44-84] and 71 [IQR 56-90], p = 0.52). The odds for severe pain (highest pain VAS≥70) were similar between the groups (IVPCA group OR 0.51 [95% Confidence Interval 0.22-1.18], p = 0.118). In contrast, the odds for mild or tolerable pain (highest pain VAS≤40) were higher in the IVPCA group (OR 4.06 [95% CI 1.05-16.04], p = 0.043). Nevertheless, satisfaction with care was high (VAS 94 [89-100]) in both groups. Of those experiencing severe pain, 94.0% declared pain medication as adequate.. Women often experience severe pain during medical abortion irrespective of the mode of opiate administration. Oxycodone administration via IVPCA permits women to self-administer analgesics when experiencing pain, raising the odds for mild or tolerable pain during abortion care. Satisfaction with care was high.. Medical abortion in late-first- and second-trimester is often painful experience. IVPCA offers a good method of choice for analgesia and raises the odds for tolerable pain (pain VAS less than 40) experience when compared to on-demand administration of analgesics.

Topics: Abortion, Induced; Administration, Oral; Analgesia, Patient-Controlled; Analgesics; Female; Humans; Infant; Infusions, Intravenous; Mifepristone; Misoprostol; Oxycodone; Pain; Pregnancy; Prospective Studies

To compare pain levels and medication needs after placement of laminaria vs Dilapan-S, and after dilation and evacuation (D&E).. We conducted a single-blinded randomized control trial of patients undergoing D&E at 15 0/7 to 23 6/7 weeks gestation, randomizing to cervical preparation with laminaria or Dilapan-S. We compared pain levels and medication usage following dilator placement (5 minutes; 2, 4, and 8 hours; the following morning) and D&E (1, 4, 24, and 48 hours). Our primary outcome was median change from baseline pain, and secondary outcomes included maximum pain timing and overall narcotic use. We compared baseline characteristics, median pain increases and quantities of narcotics used.. We analyzed 67 participants with laminaria (n = 34) and Dilapan-S (n = 33). More Dilapan-S users had a prior vaginal delivery (n = 20, 60.6%) than laminaria users (n = 11, 32.4%), p = 0.02. Maximum median pain was not statistically different (Laminaria: +3.5 (interquartile range [IQR] +0.5, +6.5); Dilapan-S: +3 (IQR +1, +5); p = 0.42. Thirty-seven (63.8%) participants reported higher levels of pain following dilator placement than D&E. Overall, 26 (42.6%) participants used narcotics during their abortion episode, with no difference in median number of tablets between laminaria (2, range 1-8) and Dilapan-S (4.5, range 1-15) participants (p = 0.34).. Median pain increase did not differ in participants receiving laminaria or Dilapan-S for cervical preparation prior to D&E. The majority of patients will use a small amount of narcotics if available.. The lack of difference in pain between laminaria and Dilapan-S enhances the applicability of pain intervention research across dilator types. With over half of participants using a small amount of narcotics during their D&E episode, pain management should be individualized to patient needs.

Topics: Abortion, Induced; Analgesics, Opioid; Female; Humans; Laminaria; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, Second

To determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion.. We conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction.. We enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0001). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness (p = 0.004), headache (p = 0.03), and vomiting (p < 0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group (p = 0.05); overall abortion satisfaction did not differ by group (p = 0.44).. Compared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects.. Given that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Female; Humans; Mifepristone; Misoprostol; Pain; Pain Management; Pregnancy

To compare participant-reported bleeding and pain with two medication regimens for early pregnancy loss (EPL).. We performed a secondary analysis of a randomized trial in which participants took either mifepristone 200 mg orally followed by misoprostol 800 mcg vaginally 24 hours later or misoprostol alone for medical management of EPL. Participants reported bleeding and pain (Numeric Pain Rating Scale, NPRS, 0-10) with daily paper diaries and at study visits on trial days 3, 8, and 30. We used, Fisher's exact, Pearson chi-square, Wilcoxon rank sum, and Student's t-tests to compare onset, duration, and severity of bleeding and pain symptoms between trial arms after misoprostol administration.. Among 291 participants who submitted diary data, 143 received mifepristone pretreatment. A larger proportion of this group reported moderate or heavy bleeding on trial day 2, the day of misoprostol administration, compared with those who did not receive pretreatment (73% vs 47%, p < 0.01). Between days 4 and 8, more mifepristone-pretreatment participants reported mild or no bleeding, compared with the misoprostol-only arm (78% vs 61%, p < 0.01). Average pain score for trial days 2-4 was higher for the pretreatment group compared with the misoprostol-only group (6.9 vs 6.0, p = 0.01), and there was a trend toward shorter total duration of pain (15 vs 19 hours, p = 0.08). These differences remained after controlling for treatment success across arms.. Mifepristone pretreatment increased the severity of pain but not bleeding and resulted in a shorter trajectory of symptoms during medical management of EPL.. Mifepristone pretreatment decreases the duration of heavy bleeding and there was a trend toward decreased duration of pain during medical management of miscarriage, indicating that this medication improves the efficiency, in addition to the efficacy, of this treatment.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Abortion, Spontaneous; Female; Humans; Mifepristone; Misoprostol; Pain; Pregnancy

To evaluate the effectiveness of celecoxib for pain relief and antipyresis during second trimester abortion using sublingual misoprostol.. Fifty-six pregnant women of gestational age 14-24 weeks were randomly assigned in a double-blind randomized controlled trial to receive 400 mg of celecoxib or placebo just before sublingual administration of misoprostol 400 µg every 6 h. Pain and body temperature (BT) were assessed every 1 h until the abortion or 24 h after the first dose of misoprostol. Pain was assessed using a 10-cm Visual Analog Scale (VAS). BT was measured with an infrared thermometer.. From January 2016 through September 2016, 28 patients were randomized into each study group. The mean VAS pain score at the completion of the abortion in the celecoxib group was significantly lower than in the placebo group (4.6 ± 2.8 vs. 7.3 ± 2.2) (p = 0.012). But 42.9% of patients in both groups experienced severe pain and needed equivalent amounts of morphine rescue. The overall mean BT in the celecoxib group was significantly lower than in the placebo group [- 0.09 (SD = 0.04)] (p = 0.017). The mean BTs at 1, 2 and 6 h after each repeated dose of misoprostol in the celecoxib group were also significantly lower than in the placebo group.. Single-dose 400 mg celecoxib had an inadequate beneficial effect on pain relief but significant antipyretic effect during second trimester abortions using sublingual misoprostol.

Topics: Abortion, Therapeutic; Administration, Sublingual; Adult; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Celecoxib; Double-Blind Method; Female; Gestational Age; Humans; Misoprostol; Outcome Assessment, Health Care; Pain; Pain Management; Pain Measurement; Pain, Postoperative; Pregnancy; Pregnancy Trimester, Second

The aim of the study was to evaluate the value of vaginal misoprostol 6 h prior to intrauterine device (IUD) insertion in women with previous Caesarean delivery.. A double-blind randomised controlled trial was conducted in 120 women who were eligible for IUD insertion. Participants were randomly divided to receive either 600 μg vaginal misoprostol or placebo 6 h before IUD insertion. The primary outcome measure was the pain score during the procedure. Secondary outcome measures were failure of insertion, insertion difficulty score, complications of IUD insertion and side effects related to misoprostol.. Pain and insertion difficulty scores were significantly lower in the misoprostol group compared with the placebo group (5.7 ± 1.4 vs. 6.5 ± 0.9 and 4.1 ± 1.1 vs. 5.4 ± 2.2, respectively; p < .001). More women experienced nausea, vomiting (5 vs. 0; p = .06) and cramps (10 vs. 0; p < .001) in the misoprostol group than in the placebo group, respectively.. The use of misoprostol before IUD insertion is associated with less painful and easier placement.

Topics: Abortifacient Agents, Nonsteroidal; Adult; Cesarean Section; Double-Blind Method; Egypt; Female; Humans; Intrauterine Devices; Linear Models; Misoprostol; Nausea; Pain; Pain Measurement; Placebos; Schools, Medical

To evaluate whether prophylactic pregabalin reduces pain experienced with medication abortion.. We conducted a randomized, double-blind, placebo-controlled trial of women initiating medication abortion with mifepristone and buccal misoprostol up to 70 days of gestation. Participants were randomized to 300 mg oral pregabalin or a placebo immediately before misoprostol. The primary outcome was maximum pain on an 11-point numerical rating scale, reported using real-time electronic surveys over 72 hours. Secondary outcomes included pain at each time point, ibuprofen and narcotic use, side effects, and satisfaction. We estimated that 110 women would be required to have 80% power to detect a difference in pain of 1.3 points.. Between June 2015 and October 2016, 241 women were screened and 110 were randomized (56 pregabalin, 54 placebo). Three were lost to follow-up. The primary outcome of mean maximum pain in the pregabalin group was 5.0±2.6 vs 5.5±2.2 in the placebo group (P=.32). Excluding medication taken before the study capsule, ibuprofen was used by 64% (35/55) of the pregabalin group vs 87% (45/52) placebo (P<.01). Narcotics were used by 29% (16/55) of the pregabalin group vs 50% (26/52) placebo (P<.03). More dizziness (P<.001), sleepiness (P<.04), and blurred vision (P<.05) occurred in the pregabalin group. Satisfaction scores for the analgesic regimen were higher in the pregabalin group (very satisfied: 47% vs 22%; P=.006).. Compared with placebo, 300 mg pregabalin coadministered with misoprostol during medication abortion did not significantly decrease maximum pain scores. Women who received pregabalin were less likely to require any ibuprofen or narcotic and were more likely to report higher satisfaction with analgesia, despite an increase in dizziness, sleepiness, and blurred vision.. ClinicalTrials.gov, NCT02782169.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adolescent; Adult; Analgesics; Female; Humans; Misoprostol; Pain; Pregabalin; Pregnancy; Young Adult

The current study aims to evaluate if vaginal misoprostol (400 mcg) administered prior to intrauterine device (IUD) insertion increases the ease and success of insertion among women who had delivered only by elective cesarean delivery (CD).. The current study was a randomized, double-blind, placebo-controlled trial conducted in Assiut Women's Health Hospital, Egypt, between the 1st of April 2015 and the 31st of March 2016 and included women who delivered only by elective CD. One hundred forty women were randomized into two groups; misoprostol group received two misoprostol 400-mcg tablets vaginally, and placebo group received two placebo tablets 3 h before a copper T380A IUD insertion. The primary outcome measure was the difference in the ease of insertion score using a 10-cm visual analog scale between both groups with 0=very easy insertion, and 10=terribly difficult insertion.. The ease of insertion score was lower in the misoprostol group (2.2±0.5 vs. 4.2±0.5, p=.0001) with higher number of successful IUD insertions than the placebo group (69 [98.6%] vs. 61 [87.1%], p=.009). The mean pain score reported by the women was lower in misoprostol group (2.7±0.6 vs. 4.3±0.8) with higher level of satisfaction from the whole procedure (8.9±0.4 vs. 7.9±0.2) with p=.001 for both.. Misoprostol 400 mcg vaginally prior to IUD insertion eases and increase the success of insertion with reduction of pain among women who had delivered only by elective CD.. The use of vaginal misoprostol before IUD insertion in women who had never delivered vaginally before may increase the ease and success of insertion. Moreover, it may reduce the pain felt by women during the procedure.

Topics: Administration, Intravaginal; Adolescent; Adult; Cesarean Section; Contraception; Double-Blind Method; Egypt; Elective Surgical Procedures; Female; Humans; Intrauterine Devices; Intrauterine Devices, Copper; Middle Aged; Misoprostol; Pain; Pain Measurement; Patient Satisfaction; Placebos; Pregnancy

To determine the optimal timing of vaginal misoprostol administration in nulliparous women undergoing office hysteroscopy.. Randomized double-blind placebo-controlled study.. University teaching hospital.. One hundred twenty nulliparous patients were randomly allocated in a 1:1 ratio to the long-interval misoprostol group or the short-interval misoprostol group.. In the long-interval misoprostol group, two misoprostol tablets (400 μg) and two placebo tablets were administered vaginally at 12 and 3 hours, respectively, before office hysteroscopy. In the short-interval misoprostol group, two placebo tablets and two misoprostol tablets (400 μg) were administered vaginally 12 and 3 hours, respectively, before office hysteroscopy.. The severity of pain was assessed by the patients with the use of a 100-mm visual analog scale (VAS). The operators assessed the ease of the passage of the hysteroscope through the cervical canal with the use of a 100-mm VAS as well.. Pain scores during the procedure were significantly lower in the long-interval misoprostol group (37.98 ± 13.13 vs. 51.98 ± 20.68). In contrast, the pain scores 30 minutes after the procedure were similar between the two groups (11.92 ± 7.22 vs. 13.3 ± 6.73). Moreover, the passage of the hysteroscope through the cervical canal was easier in the long-interval misoprostol group (48.9 ± 17.79 vs. 58.28 ± 21.85).. Vaginal misoprostol administration 12 hours before office hysteroscopy was more effective than vaginal misoprostol administration 3 hours before office hysteroscopy in relieving pain experienced by nulliparous patients undergoing office hysteroscopy.. NCT02316301.

Topics: Administration, Intravaginal; Adult; Ambulatory Care; Double-Blind Method; Drug Administration Schedule; Egypt; Female; Hospitals, University; Humans; Hysteroscopy; Misoprostol; Office Visits; Oxytocics; Pain; Pain Measurement; Parity; Time Factors; Treatment Outcome; Young Adult

Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting.. We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days' gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women's physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion.. Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed.. ACTRN12613000017729 (Prospectively registered 8/1/2013).

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adolescent; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Antiemetics; Clinical Protocols; Double-Blind Method; Drug Administration Schedule; Female; Humans; Ibuprofen; Metoclopramide; Mifepristone; Misoprostol; Pain; Pain Management; Postoperative Nausea and Vomiting; Pregnancy; Research Design; Tramadol; Young Adult

To examine the effects of preprocedure misoprostol on intrauterine device (IUD) placement in nulliparous women.. In this randomized controlled double-blind trial at the University of New Mexico reproductive health clinic, nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion. Primary outcomes included pain on a 10-cm visual analog scale and women's perception of the value of delaying insertion for an effective medication. Provider ease of insertion and need for adjunctive insertion measures were also assessed, on a visual analog scale. Participants indicated maximum pain after IUD insertion, pain level they would tolerate to avoid delay in IUD insertion, and preference for IUD insertion without delay if an effective medication was available.. Of 85 women enrolled, 3 were ineligible; 42 were randomized to misoprostol and 40 to placebo. There were no differences between groups in worst insertion pain, (5.8 ± 2.0 vs 5.9 ± 2.0, P = .94), provider ease of insertion (2.2 ± 2.2 vs 2.5 ± 2.2; P = .54) or adjunctive measures (14% vs 25%; P = .27). The groups were willing to tolerate the same mean pain (4.9 ± 2.5 vs 5.7 ± 2.4, P = .18) to avoid waiting for medication. The majority of women (85%) preferred to wait for an effective medication.. Misoprostol for nulliparous women did not decrease pain or improve the ease of insertion of an IUD. Most women were willing to wait for a medication that decreases pain, indicating a need to pursue alternatives for pain control with IUD insertion.

Topics: Adolescent; Adult; Analgesics; Double-Blind Method; Female; Humans; Intrauterine Devices; Mexico; Misoprostol; Pain; Pain Measurement; Patient Satisfaction; Treatment Outcome

To investigate whether sublingual misoprostol administered one hour before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in parous women delivered only by elective caesarean section (CS).. Single-blind randomised controlled trial conducted in Ismailia, Egypt, between July 2010 and December 2011. Women who had never delivered otherwise than by elective CS and desirous of using an IUD were randomly allocated to receive sublingually 400 μg misoprostol and 100 mg diclofenac (misoprostol group) or 100 mg diclofenac alone (control group) one hour before IUD insertion. Outcome measures were failed insertion, ease of insertion judged by the investigators, insertion-related complications, and patients' satisfaction.. In all, 255 women (130 and 125 in the study and control groups, respectively) had an IUD inserted. Seven insertions failed: five in the control group, and two in the study group. Ease of insertion and patients' satisfaction were comparable in both groups. Abdominal pain and nausea were the commonest side effects reported in the misoprostol group.. Sublingual administration of misoprostol one hour before IUD insertion in parous women with no previous vaginal delivery does not facilitate the procedure and may cause undesirable side effects. This approach is not recommended as a standard treatment.

Topics: Administration, Sublingual; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Drug Therapy, Combination; Egypt; Female; Humans; Intrauterine Devices, Copper; Misoprostol; Oxytocics; Pain; Prosthesis Implantation; Single-Blind Method; Young Adult

Barriers to intrauterine device (IUD) use in nulliparous women include fear of pain with insertion and provider perception of difficulty with insertion. The goal of this study was to evaluate whether misoprostol prior to IUD insertion in nulliparous women eased insertion and decreased pain.. This was a double-blinded, randomized, controlled trial. Nulliparous women requesting an IUD were randomized to buccal placement of 400-mcg misoprostol or placebo. Provider ease of insertion and patient-reported pain were measured using a 100-mm visual analogue scale.. Seventy-three subjects completed the study. Baseline characteristics were similar between groups. Provider perception of ease of insertion was not different between study and control groups (28.97 mm, 22.33 mm, p=.18). Pain immediately prior to IUD insertion (10.84 vs. 2.11; p=.003) and after IUD insertion (46.50 vs. 35.14; p=.040) was higher for those in the study group compared to the control group.. This study demonstrates that it is not helpful to provide misoprostol for cervical ripening prior to insertion of IUDs as it does not improve ease of insertion for provider or decrease reported pain for the woman, and it may increase women's pain experience with insertion.. Our study demonstrates that providers do not perceive nulliparous IUD insertion as difficult; women do experience pain with insertion but find the experience acceptable. The addition of misoprostol for cervical ripening prior to insertion does not ease insertion for providers and increases the pain level experienced by women.

Topics: Adult; Cervical Ripening; Double-Blind Method; Female; Humans; Intrauterine Devices; Misoprostol; Pain; Pain Measurement; Parity; Pregnancy; Self Administration; Treatment Outcome

To compare the efficacy of Laminaria tents with Misoprostol for cervical ripening before surgical process in missed abortion.. In a prospective study, 70 women with missed abortion were assigned to have either insertion of a 3 mm intracervical Laminaria tent (n = 35) or vaginal Misoprostol 400 μg (n = 35) on the day prior to suction dilation and curettage (D/C). The women were interviewed just prior to the D/C with regard to pain, vaginal bleeding, and cervical dilator preference.. Cervical dilation was greater in the Laminaria group but not significantly different from that in the Misoprostol group. However, additional cervical dilation before D/C was required in more patients in the Misoprostol group (45.7 vs 14.3%, P = 0.001). Women who received Laminaria reported significantly more pain at the time of insertion (62.8% in Laminaria group vs 22.8% in Misoprostol group) compared with women who received Misoprostol. Conversely, Misoprostol was associated with more nausea, vomiting, diarrhea and vaginal bleeding.. Laminaria tents are more effective cervical dilators than vaginal Misoprostol when inserted the day prior to suction D and C. Vaginal Misoprostol insertion is more comfortable, although it is associated with an increased risk of vaginal bleeding.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Missed; Administration, Intravaginal; Adult; Cervical Ripening; Diarrhea; Dilatation and Curettage; Female; Humans; Labor Stage, First; Laminaria; Misoprostol; Nausea; Pain; Pregnancy; Uterine Hemorrhage; Vomiting; Young Adult

To determine the efficacy of pre-emptive administration of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen vs. a placebo on pain relief during medical abortion and to evaluate whether NSAIDs interfere with the action of misoprostol.. Prospective, double-blind, randomized, controlled study.. University-affiliated tertiary hospital.. Sixty-one women who underwent first-trimester termination of pregnancy.. Patients received 600 mg mifepristone orally, followed by 400 μg oral misoprostol 2 days later. They were randomized to receive pre-emptively two tablets of 400 mg ibuprofen orally or a placebo, when taking the misoprostol. The patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after the medical abortion.. Significant pain, assessed by the need for additional analgesia, and failure rates, defined by a need for surgical intervention.. Pre-emptive ibuprofen treatment was found to be more effective than a placebo in pain prevention, as determined by a significantly lower need for additional analgesia: 11 of 29 (38%) vs. 25 of 32 (78%), respectively. Treatment failure rate was not statistically different between the ibuprofen and placebo groups: 4 of 28 (14.2%) vs. 3 of 31 (9.7%), respectively. History of menstrual pain was predictive for the need of additional analgesia.. Pre-emptive use of ibuprofen had a statistically significant beneficial effect on the need for pain relief during a mifepristone and misoprostol regimen for medical abortion. Ibuprofen did not adversely affect the outcome of medical abortion.. NCT00997074.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Oral; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Chi-Square Distribution; Double-Blind Method; Drug Administration Schedule; Female; Hospitals, University; Humans; Ibuprofen; Israel; Logistic Models; Middle Aged; Mifepristone; Misoprostol; Odds Ratio; Pain; Pain Measurement; Placebos; Pregnancy; Prospective Studies; Surveys and Questionnaires; Time Factors; Treatment Outcome; Young Adult

To compare immediate vs delayed medical treatment for first-trimester miscarriage.. Randomized open-label trial in a university hospital gynecologic emergency department. Between April 2003 and April 2006, 182 women diagnosed with spontaneous abortion before 14 weeks' gestation were assigned to immediate medical treatment (oral mifepristone, followed 48 hours later by vaginal misoprostol, n = 91) or sequential management (1 week of watchful waiting followed, if necessary, by the above-described medical treatment, n = 91). Vacuum aspiration was performed in case of treatment failure, hemorrhage, pain, infection, or patient request.. Compared with immediate medical treatment, sequential management resulted in twice as many vacuum aspirations overall (43.5% vs 19.1%; P < .001), 4 times as many emergent vacuum aspirations (20% vs 4.5%; P = .001), and twice as many unplanned visits to the emergency department (34.1% vs 16.9%; P = .009).. Delaying medical treatment of first-trimester miscarriage increases the rate of unplanned surgical uterine evacuation.

Topics: Abortifacient Agents; Abortion, Spontaneous; Adult; Female; Hemorrhage; Humans; Infections; Mifepristone; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, First; Treatment Outcome; Vacuum Curettage

To estimate the effects of self-administered misoprostol compared with placebo before intrauterine device (IUD) insertion in nulliparous women.. Nulliparous women requesting either the copper T380A or levonorgestrel IUD were randomized to self-administer either 400 μg of misoprostol or placebo (vaginally or buccally) 3-4 hours before the IUD insertion appointment. The primary outcome was health care provider-perceived ease of insertion recorded on a visual analog scale (anchors: 0 extremely easy, 100 impossible). Patients completed questionnaires addressing pain using a validated visual analog scale (anchors: 0 none, 100 worst imaginable) before insertion, immediately postinsertion, and before clinic discharge.. Of the 108 women enrolled in the study, 54 received misoprostol and 54 received placebo. There was no significant difference in perceived ease of insertion between the two groups (25.0 mm [standard error 3.5] compared with 27.4 mm [standard error 3.5], P=.64). Patients who received misoprostol before IUD insertion had significantly higher pain scores before placement (17.1 mm [standard error 3.5] compared with 4.7 mm [standard error 2.0], P=.003). Groups did not differ in perception of pain during IUD insertion (58.4 mm [standard error 3.3] compared with 56.9 mm [standard error 3.0], P=.74). There were two expulsions in the misoprostol group and none in the placebo group. Failed insertions, need for adjuvant pain medication, and need for cervical dilation or ultrasonographic guidance did not differ between the two groups.. Self-administered misoprostol before IUD insertion does not ease IUD insertion or reduce patient-perceived pain in nulliparous women. These data do not support the routine use of misoprostol before IUD insertion in nulliparous women.. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00886834.. I.

Topics: Adult; Double-Blind Method; Female; Humans; Intrauterine Devices; Misoprostol; Oxytocics; Pain; Parity; Pregnancy; Self Administration; Young Adult

This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women.. Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider "ease of placement" (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34.. A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported.. Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.

Topics: Adult; Analgesics; Chi-Square Distribution; Female; Humans; Intrauterine Devices; Misoprostol; Pain; Pain Measurement; Young Adult

To compare the effectiveness of a combination of intrauterine lignocaine and vaginal misoprostol in reducing pain at hysteroscopy and endometrial aspiration (EA).. Prospective randomized trial (Canadian Task Force Classification I).. Tertiary care referral hospital.. Forty-nine premenopausal women undergoing hysteroscopy plus EA.. Patients were randomized into misoprostol plus intrauterine lignocaine group (Group I) and only misoprostol group (Group II).. Pain scores at hysteroscope insertion (T (time) 1), during and after hysteroscopy (T2, T3), during EA (T4), 15 minutes after the procedure (T5) and at discharge (T6). Satisfaction and procedure acceptability was assessed by a questionnaire.. The mean age of patients in Group I and Group II was 35.4 +/- 8.6 years and 38.9 +/- 13.2 years, respectively. The mean pain scores in Group I were 23.6% lower at T2 and 27% lower at T4 when compared with Group II; the difference of latter being significant.. A combination of intrauterine lignocaine plus vaginal misoprostol reduced the pain score in premenopausal women undergoing hysteroscopy and EA.

Topics: Administration, Intravaginal; Adult; Ambulatory Care; Anesthetics, Local; Biopsy, Fine-Needle; Endometrium; Female; Humans; Hysteroscopy; Lidocaine; Misoprostol; Oxytocics; Pain; Pain Measurement; Patient Satisfaction; Premenopause; Prospective Studies

To compare the psychological impact, acceptability and clinical effectiveness of medical versus surgical termination of pregnancy (TOP) at 13-20 weeks of gestation.. Randomised trial.. Large UK tertiary centre.. Women accepted for TOP at 13-20 weeks of gestation.. Medical TOP (MTOP) using mifepristone and misoprostol or surgical TOP (STOP) by vacuum aspiration at <15 weeks of gestation, and by dilatation and evacuation at 15 or more weeks of gestation.. Distress 2 weeks after TOP, measured by the impact of events scale (IES), and acceptability, measured by the proportion of women who would opt for the same procedure again.. One hundred and twenty two women were randomised: 60 to the MTOP group and 62 to the STOP group. Twelve women opted to continue their pregnancy. Follow-up rates were low (n=66/110; 60%). At 2 weeks post-procedure there was no difference in total IES score between groups. However, compared with women undergoing STOP, women undergoing MTOP had a higher score on the IES intrusion subscale (mean difference 6.6; 95% CI 1.4-11.8), and a higher score on the general health questionnaire (GHQ) (P=0.033). Women found STOP more acceptable: compared with MTOP, more women would opt for the same procedure again (100% versus 53%, P≤0.001), and fewer women found the experience to be worse than expected (0% versus 53%, P=0.001). Women who had MTOP experienced more bleeding (P=0.003), more pain on the day of the procedure (P=0.008), and more days of pain (P=0.020). Of the 107 women who declined to participate, 58 (67%) preferred a STOP.. Randomised trials of women requesting midtrimester TOP are challenging. Women found STOP less painful and more acceptable than MTOP.

Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Aged; Aged, 80 and over; Dilatation and Curettage; Female; Humans; Middle Aged; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Pregnancy Trimester, First; Pregnancy Trimester, Second; Prospective Studies; Treatment Outcome; Vacuum Extraction, Obstetrical

Uptake of the mifepristone/misoprostol combination to induce early medical abortion in England and Wales has been slow. Women's concern that early medical abortion is painful may be a contributory factor. This pilot study evaluated the pain experienced by women when Dilapan-S, a synthetic hygroscopic dilator (polyacrylonitrile) is used instead of mifepristone as cervical preparation prior to administration of a misoprostol.. Of 25 patients completing the trial, 17 aborted in a median of 6 hours with an interquartile range of 4.5-11.5 hours. Of these, 15 patients recorded mild discomfort only, 14 considered the procedure excellent and three good.. This study suggests that the Dilapan-S/misoprostol combination reduces the pain associated with early medical abortion. Further investigation of the protocol is merited.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Dilatation; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Pain; Pilot Projects; Polymers; Pregnancy; Pregnancy Trimester, First; Wettability

To assess the effectiveness and tolerability of misoprostol to reduce the amount and duration of vaginal bleeding following surgical evacuation for first trimester spontaneous abortion.. A total of 160 patients who underwent surgical evacuation for first trimester spontaneous abortion between 8 and 12 weeks of pregnancy were randomized into 2 groups to receive either 200 microg of oral misoprostol immediately after evacuation followed every 6 hours for 48 hours or no misoprostol. Pain scores, duration and amount of bleeding, and endometrial thickness were assessed over 10 days.. Women who received misoprostol had significantly fewer bleeding days after evacuation (4.11+/-2.69 vs 5.89+/-3.06; P<0.001), fewer patients reported vaginal bleeding lasting 10 days or more (3.8% vs 15.0%; P=0.014), and endometrial thickness 10 days after evacuation was less (6.25+/-2.38 vs 7.23+/-1.94; P=0.05). Pain scores were comparable in both groups (1.54+/-0.65 vs 1.63+/-0.83; P=0.40) after 10 days.. Oral misoprostol is effective in reducing the prevalence and amount of vaginal bleeding after surgical evacuation for first trimester spontaneous abortion.

Topics: Abortion, Spontaneous; Administration, Oral; Adult; Endometrium; Female; Follow-Up Studies; Humans; Misoprostol; Oxytocics; Pain; Pain Measurement; Pregnancy; Pregnancy Trimester, First; Prospective Studies; Treatment Outcome; Uterine Hemorrhage; Young Adult

To determine if the use of oral misoprostol in women undergoing endometrial biopsy reduces procedural discomfort.. Women undergoing endometrial biopsy were randomized to receive either 400 microg misoprostol or a vitamin B6 placebo orally 12 hours prior to the procedure, and were stratified based on menopausal status. The primary outcome was procedural discomfort on a visual analogue scale (0-10). Secondary outcomes included the need to dilate the cervix or use a tenaculum, and side effects. Subgroup analyses were planned for premenopausal and postmenopausal women separately. Sample size calculation was based on detecting a 50% reduction in pain, with alpha = 0.05 and beta = 0.10, in the premenopausal group.. A total of 72 women (49 premenopausal and 23 postmenopausal) were enrolled; 35 received misoprostol (23 premenopausal and 12 postmenopausal) and 37 received placebo (26 premenopausal and 11 postmenopausal). There were no significant differences in procedural discomfort (misoprostol vs. placebo 5.8 +/- 2.9 vs. 5.5 +/- 3.2, P = 0.77; premenopausal women 4.9 +/- 3.3 vs. 5.1 +/- 3.1, P = 0.85; postmenopausal women 7.1 +/- 1.9 vs. 7.1 +/- 2.3, P = 0.99), need to dilate the cervix (6.1% vs. 5.6%, P = 0.93) or use a tenaculum (44.1% vs. 48.6%, P = 0.70). Significantly more women in the misoprostol group experienced nausea (31.4% vs. 2.7%, P = 0.001), diarrhea (20.0% vs. 2.7%, P = 0.02), abdominal pain (22.9% vs. 5.4%, P = 0.03), menstrual-like cramping (42.9% vs. 2.7%, P < 0.001) and vaginal bleeding (11.4% vs. 0%, P = 0.03).. The use of 400 microg oral misoprostol 12 hours prior to endometrial biopsy did not reduce procedural discomfort and was associated with more side effects than use of placebo. This finding was noted in all women as well as among subgroups of premenopausal and postmenopausal women.

Topics: Administration, Oral; Adult; Biopsy; Double-Blind Method; Endometrium; Female; Humans; Intraoperative Complications; Middle Aged; Misoprostol; Oxytocics; Pain; Pain Management; Vitamin B 6

We evaluated the sociodemographic and clinical factors, including expectations, associated with satisfaction with medication abortion.. Four sites enrolled 1080 subjects in a randomized trial of misoprostol 6-8 h versus misoprostol 24 h after mifepristone treatment for abortion at up to 63 days' gestation. Method acceptability was evaluated by preabortion and postabortion interviews and with visual analog scales examining subject factors, side effects, preferences and dislikes with the experience, pain, bleeding and stated as well as measured differences from expectations.. Nulliparity and increasing gestational age (GA) were independently associated with experiencing more pain than expected. Higher GA was associated with heavier and longer bleeding than expected. Although 89.7% of the subjects would choose medication abortion again, only 58% rated the experience as positive. Independent predictors of a positive experience included older subject age, clinic site, efficacy and less pain and bleeding than expected. Significant predictors of not choosing medication abortion again were procedure failure and more pain and bleeding than expected. All outcomes were independent of the randomization group in the main study.. Satisfaction with medication abortion may be limited by differences between patients' expectations of pain and bleeding and their experienced symptoms. These differences between expectations and experience and the actual symptoms of pain and bleeding are associated with increasing GA and nulliparity. Pain, bleeding and method failure independently predict method dissatisfaction. More information regarding severity of symptoms should be incorporated into patient counseling.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Parity; Patient Acceptance of Health Care; Pregnancy; Treatment Failure; Uterine Hemorrhage

To evaluate the efficacy of intrauterine lidocaine plus buccal misoprostol in reducing the discomfort caused by endometrial biopsy with a suction curette.. In this double-blind, randomized, placebo-controlled trial 126 women undergoing endometrial biopsy were administered a 200-microg tablet of misoprostol buccally, followed by a 5-mL uterine instillation of either of 2% lidocaine or a saline solution. The main outcome measures were the intensity of pain during, immediately following, and 20 min following the biopsy, as assessed on a 10-cm visual analog scale. Statistical analysis was performed using the Friedman test with the Bonferroni correction, the t test, and the chi(2) test.. There were no statistically significant differences between the study and control groups in mean age, parity, or relevant medical history. A statistically significant difference in pain scores was noted in premenopausal women during the procedure (lidocaine, 4.93+/-1.67; placebo, 6.17+/-1.26; P<0.001) as well as immediately later (lidocaine, 4.12+/-1.14 vs. placebo, 5.42+/-1.08; P<0.001) and 20 min later (lidocaine, 3.60+/-1.10; placebo, 4.22+/-1.46; P<0.001). No significant differences in pain scores were observed in postmenopausal women for any of the 3 time points (6.72+/-2.01, 5.18+/-1.22, and 4.56+/-0.80, respectively; P>0.05). The number needed to treat was 2.6 (95% confidence interval, 1.9-4.8).. Intrauterine lidocaine plus buccal misoprostol appears to be effective in decreasing pain in premenopausal women undergoing endometrial biopsy with a suction curette.

Topics: Administration, Intravaginal; Anesthesia, Conduction; Anesthesia, Obstetrical; Anesthetics, Combined; Anesthetics, Local; Biopsy, Needle; Double-Blind Method; Endometrium; Female; Humans; Lidocaine; Misoprostol; Pain; Pain Measurement; Vacuum Curettage

Mifepristone was compared with laminaria for cervical ripening in second-trimester induction of labor (IOL).. We performed a randomized, controlled, open-label study of women undergoing second-trimester IOL for fetal demise, aneuploidy or anomalies at a single tertiary care center from January 2004 to May 2006. Main outcome measures were induction-to-delivery time and pain with cervical ripening.. Of 50 eligible women, 37 were enrolled in the study, of whom 33 completed the study: 16 were randomized to laminaria and 17 to mifepristone. Induction-to-delivery time was significantly shorter in the mifepristone arm (mean=10 h vs. 16 h, p=.01; median=7.5 h vs. 13.4 h, p=.01). Pain with cervical ripening was also significantly less in the mifepristone group than in the laminaria group (median=1 vs. 6 on an 11-point visual analogue scale, p<.001). Maternal age, parity, gestational age, fetal demise prior to induction, need for postpartum curettage, blood loss, pain during induction, delivery and at the time of discharge were not significantly different between the two groups.. Mifepristone shortens the induction-to-delivery time and decreases pain with cervical ripening when compared with laminaria for second-trimester induction.

Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Cervical Ripening; Female; Humans; Labor, Induced; Laminaria; Mifepristone; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, Second; Time Factors

Sublingual and vaginal routes of misoprostol have been found to be effective for pharmacological ripening prior to surgical termination of first trimester abortions. We conducted this study to compare the effectiveness and acceptability of sublingual versus vaginal route of misoprostol for cervical priming prior to vacuum aspiration (VA).. In this prospective clinical trial, a total of 100 women with period of gestation between 6 and 12 weeks scheduled for day surgery abortion were sequentially allocated into two groups of 50 each. All participating women received 400 microg of misoprostol 3 h prior to VA either by sublingual (self-administered at home) or by vaginal route (inserted by the doctor in hospital) after wetting the tablet with water.. Demographic characteristics of both the groups were comparable. For all periods of gestation, sublingual misoprostol significantly improved cervical dilatation (p<0.001) and reduced the time duration of surgery (p<0.001) compared to vaginal group without increasing the side effects. Mean pain score of the sublingual group was 2.7+/-1.1 as compared to 3.2+/-1.6 of the vaginal group (p=0.57). Misoprostol tablet was found intact in the vagina of three patients and was only partially absorbed amongst five patients at the time of VA.. Sublingual route is an effective and convenient alternative to vaginal administration of misoprostol for cervical dilatation. It can be conveniently self-administered at home thereby decreasing hospital stay and cost. It also has a good patient acceptability rate.

Topics: Abortion, Induced; Administration, Intravaginal; Administration, Sublingual; Adolescent; Adult; Cervical Ripening; Female; Humans; Misoprostol; Pain; Patient Acceptance of Health Care; Pregnancy; Pregnancy Trimester, First; Vacuum Curettage

To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion.. Randomised nonblinded trial.. Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area.. Women of reproductive age.. Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period.. Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975).. Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability.. There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adolescent; Adult; Female; Humans; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Treatment Outcome; Uterine Hemorrhage

To compare the efficacy of the medical treatment to surgical uterine evacuation and patient satisfaction in each group.. A randomized, controlled study.. An outpatient clinic in the Department of Gynecology and Obstetrics in Oulu University Hospital, Oulu, Finland.. Ninety-eight eligible women who had had miscarriages.. Medical treatment of miscarriage (n = 49) with 200 mg of mifepristone and 0.8 mg of misoprostol 1-3 days after the event or surgical uterine evacuation (n = 49). Questionnaires to collect data of experienced pain and patient satisfaction.. The complete abortion rate with the primary treatment (primary outcome) and the patient satisfaction (secondary outcome).. The success rate was equal (100% in surgical and 90% in medical group). More infections were diagnosed in the surgical group. Surgically treated patients were more satisfied with the treatment (100% vs. 88%). Medical treatment was considered more painful and fewer patients (70% vs. 91%) would choose the medical method in the future.. Medical treatment is an effective alternative to surgical treatment and increases the choice available to women. Surgical treatment is associated with more infections. More medically treated patients experienced pain and dissatisfaction.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Spontaneous; Adult; Female; Humans; Incidence; Infections; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Pregnancy Trimester, First; Treatment Outcome; Vacuum Curettage

To study if misoprostol 400 microg, administered vaginally, increased the successful resolution of early miscarriage compared with placebo.. Randomised, double blind placebo controlled study.. Sahlgrenska University Hospital, Göteborg, Sweden.. One hundred and twenty-six women seeking medical attention for early miscarriage.. Women with a non-viable, first trimester miscarriage were randomised to vaginal administration of misoprostol 400 microg or placebo.. Main outcome measure was the proportion of successful complete resolution of miscarriage. Secondary outcomes were incidence of infection, bleeding, gastrointestinal side effects, pain, use of analgesics and length of sick leave between groups.. Sixty-four patients were randomised to misoprostol and 62 to placebo. Eighty-one percent in the misoprostol and 52% in the placebo group had a complete miscarriage within one week of the primary visit (RR 1.57; 95% CI 1.20-2.06). Patients in the misoprostol group reported more pain as assessed on a visual analogue scale (60.4 [31.0] vs 43.8 [37.1] mm; P < 0.007) and required analgesics more often (83%vs 61%, RR 1.35; 95% CI 1.08-1.70). There were no significant differences in the occurrence of gastrointestinal side effects, infection, reduction in haemoglobin or sick leave between the groups.. Treatment with 400 mug misoprostol administered vaginally increased the success rate of resolvement of uncomplicated early miscarriages compared with placebo. However, women who received misoprostol experienced more pain and required more analgesics than those who did not.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Incomplete; Administration, Intravaginal; Adult; Analgesics; Anti-Bacterial Agents; Bacterial Infections; Double-Blind Method; Female; Humans; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, First; Treatment Outcome

To compare the efficacy and acceptability of same-day misoprostol and overnight laminaria for cervical ripening before early second-trimester surgical abortion.. We performed a randomized, double-blinded, controlled trial comparing 400 microg of vaginal misoprostol, given 3-4 hours preoperatively, with overnight laminaria before early second-trimester surgical abortion among women at 13.0-16.0 weeks of gestation (n = 84). The primary outcome was procedure time, and the sample size was based on 95% power to detect a difference of 4.5 minutes between groups. Secondary outcomes included completion of the procedure on the first attempt, procedural difficulty, and patients' pain scores and preferences.. The average gestational duration was 14 weeks 6 days. Procedures performed after laminaria were significantly faster than those after misoprostol (median 3.4 versus 7.2 minutes, respectively, P = .01). Laminaria patients had significantly greater dilation than misoprostol patients at abortion (mean 43 versus 33 French, P < .001), and more misoprostol patients required additional dilation (85% versus 21%, P < .001). Physicians rated 27% of the misoprostol procedures as moderate-markedly difficult versus 5% of laminaria procedures (P = .01). Differences in efficacy were pronounced among nulliparous patients. There were no significant differences in ability to complete the procedure on the first attempt or patients' intraoperative pain scores. More women in the misoprostol group would choose their assigned method again (93% versus 62%, P < .01), and 82% of all subjects preferred a 1-day procedure.. Early second-trimester abortions take longer and are technically more challenging after cervical ripening with same-day misoprostol than with overnight laminaria, but patients prefer same-day misoprostol.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Therapeutic; Adolescent; Adult; Cervical Ripening; Double-Blind Method; Female; Humans; Intraoperative Period; Laminaria; Misoprostol; Pain; Patient Acceptance of Health Care; Pregnancy; Pregnancy Trimester, Second; Time Factors; Treatment Outcome

To compare the experience of pain, need of analgesic interventions, preference and acceptability in medical abortion up to 49 days of amenorrhea with mifepristone and orally versus vaginally administered misoprostol.. Ninety-seven women were randomised to oral misoprostol, n=48, or vaginal misoprostol, n=49. On day 1 of the study, both the groups received 600 mg of mifepristone. On day 3 of the study, one group received 0.4 mg of misoprostol orally and the other group received 0.8 mg of misoprostol vaginally.. Even though oral administration of misoprostol seemed to be associated with a higher rate of gastrointestinal side effects, women in both the groups showed a clear preference towards the oral route of administration. The willingness to administer the misoprostol at home was also higher among the women in the oral group, which may in part depend on a more positive/less negative experience of the abortion.. A majority of women prefer oral administration of misoprostol in early medical abortion.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Oral; Administration, Topical; Analgesics; Female; Humans; Mifepristone; Misoprostol; Nausea; Pain; Patient Acceptance of Health Care; Patient Satisfaction; Pregnancy; Uterine Hemorrhage; Vagina; Vomiting

Although a number of studies have shown misoprostol's promise as a nonsurgical treatment for incomplete abortion, few have systematically examined treatment protocols. This study documents the effectiveness of 600 versus 1,200 microg oral misoprostol for this indication.. From May 2002 to January 2003, 300 women with incomplete abortion were recruited at a large tertiary facility in Vietnam and randomized to either a single-dose (600 microg) or a repeated-dose (600 microg x 2) regimen of oral misoprostol for the treatment of their condition.. Misoprostol effectively evacuated the uterus for nearly all women (94.6%; n=279), with most reporting bleeding for 4 days (+/-2.3) and pain/cramps lasting 1 day (+/-1.0). Women indicated that the side effects were tolerable (96%) and that their experience was satisfactory (95%).. Oral misoprostol (600 or 1,200 microg) offers a safe, effective and acceptable treatment for incomplete abortion. Larger studies to assess the advantages and disadvantages of misoprostol as compared with standard surgical care are needed to assess its role in postabortion care programs worldwide.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Incomplete; Adolescent; Adult; Female; Humans; Middle Aged; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Uterine Hemorrhage; Vietnam

To evaluate the effects of vaginal misoprostol on cervical dilatation before operative hysteroscopy in pre-menopausal women.. Four groups of 12 women were randomly assigned to receive either placebo or vaginal misoprostol in doses of 200, 400 or 800 micro g 4 h before the surgical procedure. The number of patients was calculated with an alpha = 0.01 and beta =0.20 for a difference of 50%. The primary outcome measure was cervical width, assessed by the largest size of Hegar dilator that could be inserted without resistance. The secondary outcomes were subjective assessments of the ease of dilatation and pre-operative pain, as well as adverse effects and complications.. There was no difference in the baseline diameter of the cervical opening between the placebo group (6.1 +/- 1.4 cm) and the misoprostol groups (6.3 +/- 2.1 cm). The groups did not differ significantly in the time required for dilatation, ease of dilation, or the number of adverse effects. Pre-operative pain, evaluated by a pain scale, was greater in the treatment groups and was rated at 2.5 +/- 2.3 (P = 0.015), 2.4 +/- 1.2 (P = 0.073) and 2.8 +/- 2.9 (P = 0.012) respectively for each increasing dose group.. Vaginal misoprostol applied 4 h before operative hysteroscopy at three different doses did not reduce the need for cervical dilatation, did not facilitate hysteroscopic surgery, and increased pre-operative pain.

Topics: Administration, Intravaginal; Adult; Cervix Uteri; Dilatation; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hysteroscopy; Misoprostol; Pain; Pain Measurement; Premenopause; Preoperative Care; Treatment Failure

This double-blind randomized control study was conducted to evaluate whether a nonsteroidal anti-inflammatory drug (NSAID) could act as an effective pain control method during first trimester suction abortion, and whether co-treatment of NSAID with misoprostol will decrease the efficacy of the cervical ripening effect of misoprostol. Subjects were randomized to receive misoprostol alone or misoprostol together with diclofenac sodium. Both groups of subjects suffered from similar incidence of preoperative side effects. Co-treatment of NSAID with misoprostol did not attenuate the cervical ripening efficacy of misoprostol. There was no significant pain reduction in the group treated with NSAID, except that a marginal benefit was found in the subgroup of multiparous women. About two thirds of the subjects in both treatment groups found that this was a satisfactory pain relief method during the procedure.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Cervix Uteri; Diclofenac; Double-Blind Method; Drug Interactions; Female; Humans; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, First; Premedication; Prospective Studies; Suction

The objective of the study was to evaluate the efficacy and safety of 800 microg misoprostol (Cytotec) every 8 h for 24 h for pharmacological abortion; the treatment was repeated if abortion did not occur in the first 24-h interval. The first misoprostol doses were always self-administered into the vagina; the second and third doses could be administered orally or vaginally depending on the amount of bleeding. Four-hundred and fifty-two women with gestations between 36 and 63 days were recruited into the study. The main outcomes assessed were: successful abortion (complete abortion without surgery), side effects, mean drop in hemoglobin, vaginal bleeding and mean time of return of menstruation. Complete abortion occurred in 409/452 (90.5%; 95% confidence interval [CI] 87%, 93%) patients. Medication to relieve symptoms was administered to all women before the first misoprostol dose. Vaginal bleeding lasted 15.9 +/- 4.4 days. The mean drop in hemoglobin, measured 14 days after abortion, was statistically significant (p = 0.0001) but without clinical relevance. According to the results obtained, 800 microg of misoprostol administered every 8 h for 24 h could be a valid method for abortion for up to 9 weeks of gestation.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Administration, Oral; Female; Gestational Age; Humans; Logistic Models; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Self Administration; Time Factors; Treatment Outcome

This prospective, open-label, randomized trial of healthy adult women up to 9 weeks pregnant compared mifepristone 200 mg followed 2 days later with misoprostol 400 microg orally versus misoprostol 800 microg vaginally. The study was interrupted after the oral misoprostol group experienced a higher than expected failure rate. This treatment was discontinued and another substituted consisting of oral misoprostol 800 microg divided into two doses two hours apart. Women returned for a follow-up visit from Day 4 to 8. All women with a continuing pregnancy received a repeat dose of misoprostol vaginally and returned before Day 15. The primary outcome measure was a complete medical abortion without surgical intervention at the first visit. Of the 1045 women enrolled, 1011 had complete data: Group 1 (220) used oral misoprostol 400 microg, Group 2 (269) used oral misoprostol 800 microg, and Group 3 (522) used vaginal misoprostol 800 microg. At first follow-up visit, the primary outcome, that is, a complete abortion, was 84% for Group 1, 92% for Group 2, and 96% for Group 3, p < 0.001. After a second dose of vaginal misoprostol in women with on-going pregnancies at their first follow-up visit, the complete abortion rates were 91%, 95%, and 98%, respectively, p < 0.001. There were minimal differences in side effects, onset of bleeding and overall acceptability in the three groups. Mifepristone 200 mg followed by vaginal misoprostol 2 days later was more effective at inducing an abortion up to 9 weeks of pregnancy than the same dose of mifepristone followed by oral misoprostol.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Intravaginal; Administration, Oral; Adult; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Pregnancy; Treatment Outcome; Uterine Hemorrhage

Since 1991, mifepristone in combination with a prostaglandin analogue has been licensed for termination of pregnancy in the UK at up to 9 weeks amenorrhoea, and since 1995, beyond 13 weeks. Surgical methods are used almost exclusively at 10-13 weeks amenorrhoea.. A patient-centred, partially randomized, controlled trial was carried out. Those who expressed a strong preference for either medical (n = 15) or surgical (n = 62) abortion were allocated to that method. The remainder agreed to be randomized. The medical method (n = 188) was mifepristone 200 mg followed by misoprostol up to 3 doses, and surgery (n = 180) was by vacuum aspiration under general anaesthesia. Outcome measures included efficacy rates, medical complications within 8 weeks of the procedure, patient preferences and acceptability.. Among women who underwent medical abortion, 5.4% required a second procedure compared with 2.1% who had surgery, although this difference was not statistically significant. Side effects experienced were higher in women who underwent medical abortion compared with those who underwent surgery. There were no significant differences in the rates of major complications up to 8 weeks. Prior to termination, 80% of women had a preference for a method, with 72% preferring medical and 28% preferring surgical abortion. Following abortion, 70% of those who underwent medical termination and 79% who underwent surgery would opt for the same method in the future.. Medical abortion is safe and effective at 10-13 weeks gestation and should be considered an option for those women who wish to avoid surgery and anaesthesia.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Anesthesia, General; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Postoperative Complications; Pregnancy; Treatment Outcome; Vacuum Curettage

To evaluate oral misoprostol use before office endometrial biopsy.. Forty-two nonpregnant women aged 35-77 years were randomized to a prospective, double-blind study to receive either 400 microg oral misoprostol or placebo 3 hours before office endometrial biopsy. Misoprostol effects were assessed by 1) cervical resistance, 2) ease of performing the endometrial biopsy, 3) success rate of obtaining an endometrial biopsy, 4) pain intensity associated with the endometrial biopsy, and 5) adverse clinical side effects.. Patients in the misoprostol group experienced significantly (P <.01) more pain associated with the endometrial biopsy. The observed power to detect this difference in misoprostol-placebo comparison using the Wilcoxon rank sum test at 0.05 level of significance is 89%. In addition, significantly (P <.05) more patients had the adverse side effect of uterine cramping at 1.5 hours after medication ingestion in the misoprostol group. The observed power to detect this difference is 98%. There were no differences between the misoprostol and placebo groups in cervical resistance, ease of performing the biopsy, success rate for obtaining an endometrial biopsy, or adverse side effects at 3 hours post medication ingestion.. Oral misoprostol 400 microg caused more uterine cramping and pain in nonpregnant women undergoing office endometrial biopsy when given 3 hours before biopsy attempt. No other cervical effects were noted.

Topics: Ambulatory Surgical Procedures; Biopsy; Cervix Uteri; Double-Blind Method; Endometrium; Female; Humans; Middle Aged; Misoprostol; Pain; Premedication; Prospective Studies; Time Factors; Uterine Contraction

To compare the effectiveness, side effects, and acceptability of medical abortions induced by methotrexate and misoprostol with abortions induced by mifepristone and misoprostol.. This was a multicenter, randomized, nonblinded, controlled trial comparing 50 mg/m(2) of methotrexate followed 4-6 days later by 800 microgram of vaginal misoprostol with 600 mg of oral mifepristone followed 36-48 hours by 400 microgram of oral misoprostol.. There were 518 women in the methotrexate group and 524 women in the mifepristone group. In the methotrexate group, 21 women required suction curretage, two for continuing pregnancy, eight because of physician request (usually for excessive bleeding), and 11 because of patient request. In the mifepristone group, 22 women needed surgical termination, 17 because of physician request, and five because of patient request. By day 8, only 386 (74.5%) in the methotrexate group had completed the abortion compared with 474 (90.5%) in the mifepristone group, and the mean number of days from beginning to completion was 7.1 for methotrexate and 3.3 for mifepristone (P

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Female; Hemorrhage; Humans; Methotrexate; Mifepristone; Misoprostol; Pain; Pregnancy

The objective of this study was to confirm the effectiveness and safety of self-administration of misoprostol every 24 h, for abortion up to 9 weeks of gestation. A group of 720 volunteer subjects with gestations from 35 to 63 days received 800 micrograms of vaginal misoprostol every 24 h up to a maximum of three main doses for abortion. Outcome measures assessed included successful abortion (complete abortion without requiring surgery), side effects, decrease in hemoglobin, mean time of vaginal bleeding, and mean time of return of menses. Complete abortion occurred in 644 of 720 (89.4%, 95% CI 87, 92) subjects. The mean decrease in hemoglobin was statistically significant (p = 0.0001). There were 14 subjects with clinically significant decreases in hemoglobin, but only two required transfusions. Vaginal bleeding lasted 6.7 +/- 3.9 days, spotting 8.1 +/- 4 days, and total bleeding 14 +/- 5.3 days. Mean expulsion time was 8.0 +/- 3.4 h. Although mifepristone remains unavailable, given the low price and availability of misoprostol in > 72 countries of the world, this latter drug constitutes an abortion alternative, provided that a minimum clinical network is nearby or accessible.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adolescent; Adult; Female; Gestational Age; Humans; Kinetics; Middle Aged; Misoprostol; Pain; Pregnancy; Treatment Outcome; Uterine Hemorrhage

Liberalization of the law in respect of legal abortions has led to a search for an appropriate technique for termination of pregnancy. The technique should be cheap, easy to perform and have minimal or no complications.. To evaluate the effectiveness of performing manual vacuum aspiration (MVA) with and without the use of misoprostol to the procedure.. Randomised control study.. Obstetrics and Gynaecology Department, University of Natal Medical School, South Africa.. One hundred and thirty six women were recruited; 70 women were assigned to the misoprostol group. Of these, 11 (15%) did not show any change in cervical score. Their mean cervical dilatation was similar to the control group (3.3 versus 31; p > 0.06). In the group whose gestational age was less than eight weeks, the time taken to complete the procedure, quantity of products of conception and cervical dilatation, were different from that of the control group, and this reached statistical significance except quantity of products of conception in primigravidae. In pregnancies greater than eight weeks gestation, all parameters assessed, such as cervical dilatation, quantity of products of conception was significantly different from the control group, in both multi- and primigravidae. Pain score was similar for all gestations.. Misoprostol is of specific value during MVA for voluntary interruption of pregnancy.

Topics: Abortion, Induced; Administration, Oral; Adolescent; Adult; Cervical Ripening; Double-Blind Method; Female; Gestational Age; Humans; Misoprostol; Oxytocics; Pain; Parity; Pregnancy; Pregnancy Trimester, First; South Africa; Time Factors; Treatment Outcome; Vacuum Curettage

To compare the abortifacient efficacies of two intravaginally administered misoprostol doses and gemeprost in termination of second-trimester pregnancy.. Eighty-one women between 12 and 24 weeks' gestation requesting abortion were randomized to receive intravaginally either 100 micrograms of misoprostol at 6-hour intervals (n = 27), 200 micrograms of misoprostol at 12-hour intervals (n = 26), or 1.0 mg of gemeprost at 3-hour intervals (n = 28). The regimen was continued until abortion, or for 36 hours, with assessment of the rate of complete and incomplete abortions as well as side effects within 48 hours from the start of the treatment.. The final rates of terminations were 74% in the 100-microgram misoprostol group, 92% in the 200-microgram misoprostol group, and 89% in the gemeprost group. Abortion was complete in 37%, 61%, and 32% in each group, respectively (P = .03, when the 200-microgram misoprostol group was compared with the two other groups). The induction-to-abortion interval was longer (P = .001) in the misoprostol groups (mean 23.1 hours for the 100-microgram and 27.8 hours for the 200-microgram dose) than in the gemeprost group (14.5 hours). There was less pain (P = .01), diarrhea (P = .001), and vomiting (P = .01) in the misoprostol groups than in the gemeprost group. The mean blood loss in the misoprostol groups was lower than in the gemeprost group (P = .001).. Intravaginal application of 200 micrograms of misoprostol at 12-hour intervals in induction of second-trimester abortion is equally effective to a standard gemeprost regimen. Misoprostol causes fewer side effects and is cheaper and more practical to use.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adult; Alprostadil; Diarrhea; Drug Administration Schedule; Female; Humans; Misoprostol; Nausea; Pain; Pregnancy; Pregnancy Trimester, Second; Time Factors

The prophylactic strategy of nonsteroidal antiinflammatory drug (NSAID)-induced upper gastrointestinal (UGI) damage has largely been studied in arthritic patients, but not in cancer patients. The efficacy of misoprostol and ranitidine in the prevention of gastroduodenal damage in patients taking diclofenac for their cancer pain has been compared in this study.. Patients who needed high-dose (200 to 300 mg/d) diclofenac for cancer pain and without mucosal lesions at baseline gastroduodenal endoscopy were randomized to receive misoprostol (200 micrograms twice daily; M group) or ranitidine (150 mg twice daily; R group). UGI endoscopy was repeated after 4 weeks.. Twenty-three patients treated with misoprostol and 26 treated with ranitidine concluded the study. The M group showed a significantly (P < .02) lower incidence of gastroduodenal lesions (two patients; 8.7%) than the R group (10 patients; 38.5%). Gastric ulcers occurred in one (4%) misoprostol-treated patient and in six (23%) ranitidine-treated patients. Six of seven patients with ulcers were asymptomatic. Seventy-one percent and 86% of ulcers occurred in patients older than 60 years and in those who received greater than 3.1 mg/kg of diclofenac, respectively.. Misoprostol was significantly more effective than ranitidine in the prevention of gastroduodenal lesions in cancer patients receiving diclofenac.

Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Diclofenac; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Misoprostol; Neoplasms; Odds Ratio; Pain; Ranitidine; Risk Factors; Single-Blind Method; Stomach Ulcer

To evaluate the possible protective effects of misoprostol on renal function in hospitalized elderly patients treated with indomethacin.. Forty-five hospitalized elderly patients (> 65 years old) who required therapy with nonsteroidal antiinflammatory drugs (NSAID) were randomly assigned to receive either indomethacin, 150 mg/day (Group A), or indomethacin 150 mg/day plus misoprostol at 0.6 mg/day (Group B). Laboratory variables of renal function [serum creatinine, blood urea nitrogen (BUN) and electrolytes] were evaluated before initiation of therapy and every 2 days, until termination of the study (a period of at least 6 days). Response to treatment was estimated by the visual analog scale for severity of pain.. Forty-two patients completed the study, 22 in Group A and 20 in Group B. BUN and creatinine increased by > 50% of baseline levels in 54 and 45% of Group A patients, respectively, compared to only 20 and 10% of Group B patients (p < 0.05). Potassium (K) increment of 0.6 mEq/l or more was observed in 50% of Group A, but in only 15% of Group B patients (p < 0.05). The mean increments in BUN, creatinine, and K were reduced by 63, 80, and 42%, respectively, in Group B patients compared to Group A. Response to treatment did not differ significantly between the 2 groups.. Hospitalized elderly patients are at risk for developing indomethacin related renal dysfunction. Addition of misoprostol can minimize this renal impairment without affecting pain control.

Topics: Aged; Aging; Drug Therapy, Combination; Female; Hospitalization; Humans; Indomethacin; Kidney Diseases; Male; Misoprostol; Pain; Prospective Studies; Risk Factors

Data from four double-blind studies of the treatment of patients with rheumatoid arthritis or osteoarthritis were combined. For 4 to 12 weeks, 747 patients received Arthrotec, a combination of 50 mg of diclofenac and 200 micrograms of misoprostol, and 754 patients received 50 mg of diclofenac; the drugs were given twice or three times daily. The five most commonly reported adverse events were abdominal pain by 23.2% of the diclofenac/misoprostol patients and 19.8% of the diclofenac patients; diarrhea by 19.9% and 11.3%; nausea by 11.8% and 6.5%; dyspepsia by 11.2% and 7.8%; and flatulence by 8.0% and 3.1%. Other adverse events, reported by similar proportions of both treatment groups, included headache, gastritis, dizziness, vomiting, and constipation. In the diclofenac/misoprostol-treated patients, the abdominal pain and diarrhea were rated mild in 30.6% and 24.3%, moderate in 49.1% and 51.4%, and severe in 20.2% and 24.3%. Serious adverse events occurred in eight of the diclofenac/misoprostol-treated patients and in 13 of the diclofenac-treated patients; 12.6% and 10.1%, respectively, were withdrawn from the study because of adverse events. Results of laboratory tests of hepatic and renal function were similar in the two treatment groups.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Arthritis, Rheumatoid; Constipation; Diarrhea; Diclofenac; Dizziness; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Misoprostol; Osteoarthritis; Pain; Vomiting

A questionnaire study was carried out to investigate the needs of women undergoing a medical abortion induced by mifepristone in combination with either gemeprost pessaries or oral misoprostol. One-hundred-and-eighty women undergoing medical abortion of pregnancy of up to 63 days amenorrhoea were randomised to treatment in the sitting-room (treatment room) or in the ward. Overall, 77% and 69% treated in the sitting-room and ward, respectively, would have preferred treatment in the sitting-room. Fifty-four per cent did not wish their partner or friend to be present and 76% would prefer to stay in hospital following administration of prostaglandin. Ninety-five per cent of the patients would recommend this method of abortion to their friends. Women who received misoprostol required significantly less analgesia than women who were given 1 mg gemeprost as a vaginal pessary. The requirement for opiate analgesia was not influenced by parity, gestation of pregnancy, history of dysmenorrhoea or the dose of mifepristone. Almost 100% of the patients were satisfied with this method of treatment. This study indicates that the majority of women undergoing medical abortion prefer to be treated in a group, a method which is highly cost-effective.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Acetaminophen; Administration, Oral; Adolescent; Adult; Alprostadil; Bias; Codeine; Female; Heroin; Humans; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Pessaries; Pregnancy

We conducted a 4-week double-blind randomized controlled multicentre trial to compare low-dose-antacid (AA) therapy (225 meq total neutralizing capacity per day) with therapy using the prostaglandin E1-analogue, misoprostol (MS) (400 micrograms bid), on ulcer healing and relief of symptoms in 100 outpatients with endoscopically proven duodenal ulcer (DU, 49 patients on AA, 51 patients on MS). Of the 100 patients enrolled in the study 96 could be evaluated; 49 received AA, 47 MS. Endoscopies were performed before treatment, 2 and 4 weeks after initiation of treatment. Healing rates of AA- and MS-treatment were 36.7% vs. 25.5% (2 weeks) and 79.6% vs. 74.4% (4 weeks) and did not differ as much as relief of pain during the daytime. Rates of relief of nighttime pain were significantly higher on AA-treatment after 2 weeks of treatment (81.1% vs. 48.6%; p less than 0.05), but not during the later course of treatment. Thus, it can be concluded that low-dose AA-treatment using an aluminum/magnesium hydroxide preparation in tablet form represents an effective and safe therapy for duodenal ulcer.

Topics: Adult; Aged; Antacids; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Duodenoscopy; Female; Humans; Male; Middle Aged; Misoprostol; Pain

A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were receiving ibuprofen, piroxicam, or naproxen. Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 micrograms or 200 micrograms misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0.3 cm in diameter or greater) occurred less frequently (p less than 0.001) in both misoprostol treatment groups (5.6% 100 micrograms and 1.4% 200 micrograms) than in the placebo group (21.7%). The significant difference in ulcer formation between the placebo and the misoprostol treatment groups remained when comparisons were restricted to ulcers greater than 0.5 cm in diameter (12.3% placebo, 4.2% 100 micrograms misoprostol, and 0.7% 200 micrograms misoprostol). Mild to moderate, self-limiting diarrhoea was the most frequently reported adverse effect attributed to misoprostol. These results provide the first clear indication that NSAID-induced ulcers are preventable.

Topics: Abdomen; Adult; Aged; Aged, 80 and over; Alprostadil; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Misoprostol; Multicenter Studies as Topic; Osteoarthritis; Pain; Probability; Random Allocation; Stomach Ulcer

In this double-blind, parallel-group multicenter study, patients with endoscopically proven gastric ulcers were randomly allocated to treatment with either 50 micrograms or 200 micrograms of misoprostol or 300 mg of cimetidine, each given four times daily for four weeks. Endoscopic, clinical and laboratory assessments were made before treatment and after four weeks; clinical and laboratory assessments were repeated at two weeks. In the Korean center, assessments were also made after six weeks and at eight weeks of treatment. Six hundred and thirty patients were studied. The three treatment groups were similar in age and occupation. However, the proportion of men in the misoprostol 50-micrograms, 200-micrograms and cimetidine 300-mg groups was 67%, 63%, and 59%, respectively. Therapeutic success was defined as complete healing of all ulcers, judged endoscopically. On an intent-to-treat basis, which includes all losses to follow-up and withdrawals as treatment failures, ulcer healing rates in the misoprostol 50-micrograms, 200-micrograms and cimetidine 300-mg groups were 39%, 51%, and 58%, respectively. In the Korean center, the healing rates were 38%, 64%, and 70%, respectively, after eight weeks of treatment. There was no statistically significant difference in the healing rates at four weeks between the misoprostol 200-micrograms and cimetidine 300-mg groups (P = 0.16). The healing rate with the misoprostol 200-micrograms dose was significantly better than with the 50-micrograms dose (P = 0.008). Cimetidine 300 mg relieved global pain significantly better than misoprostol 200 micrograms at two weeks (P = 0.047) but not at four weeks.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Aged; Alprostadil; Anti-Ulcer Agents; Cimetidine; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Misoprostol; Pain; Smoking; Stomach Ulcer

Chronic cigarette smoking adversely affects duodenal ulcer healing despite treatment by potent gastric acid-reducing agents. Prostaglandins of the E series possess antisecretory and cytoprotective properties and theoretically offer advantages over existing therapeutic agents. A double-blind randomized study was performed to compare complete duodenal ulcer healing as assessed by endoscopies every two weeks for up to 12 weeks. Two hundred twenty-nine patients were randomized to receive misoprostol, an orally stable synthetic derivative of prostaglandin E1, in 200-micrograms or 300-micrograms qid dosages, or placebo. Life-table analysis showed that (1) both regimens of misoprostol were significantly more effective than placebo, achieving healing rates of 61% and 71%, respectively, at four weeks, and (2) cigarette smoking significantly impaired healing by placebo but not by misoprostol. In fact, the time-healing curves of smokers and nonsmokers on the higher dose of misoprostol completely overlapped. Furthermore, delayed treatment and large ulcer diameter adversely affected healing by misoprostol in smokers, whereas in nonsmokers, high basal and maximal acid output were unfavorable. Misoprostol is recommended for the treatment of duodenal ulcer, particularly in chronic smokers early in a given period of symptoms.

Topics: Adult; Alprostadil; Anti-Ulcer Agents; Duodenal Ulcer; Female; Gastric Acid; Gastric Mucosa; Humans; Male; Misoprostol; Pain; Smoking; Wound Healing

Topics: Abortion, Spontaneous; Animals; Anti-Ulcer Agents; Cimetidine; Clinical Trials as Topic; Double-Blind Method; Duodenal Ulcer; Female; Humans; Misoprostol; Pain; Pregnancy; Prostaglandins E, Synthetic; United States; United States Food and Drug Administration

Patients with endoscopically documented duodenal ulcer participated in a double-blind, multicenter trial comparing placebo with misoprostol 100 micrograms administered q.i.d. for up to four weeks in the treatment of duodenal ulcer. Ulcers were examined endoscopically at two weeks and, if not healed, again at four weeks. Acetaminophen was permitted for pain relief. At four weeks, of 286 patients admitted to the study, the cumulative healing rate for the 227 evaluable patients was 64.9% for misoprostol and 47.4% for placebo (P = 0.008). Misoprostol was also significantly superior to placebo in promoting ulcer healing when all patients entering the study (intent-to-treat cohort) were compared (P = 0.018), and in a modified intent-to-treat cohort consisting of all patients whose final endoscopic results were known (P = 0.005). Ulcer symptoms were similar in both treatment groups, and most patients in both groups were pain free at the end of the first two weeks of treatment. Diarrhea was the most frequently reported adverse experience (8.5% for misoprostol and 3.5% for placebo). This symptom was mild and self-limiting in spite of continued use of misoprostol. We conclude that misoprostol 100 micrograms q.i.d. for four weeks is safe and effective in the healing of duodenal ulcers.

Topics: Adult; Aged; Alprostadil; Anti-Ulcer Agents; Clinical Trials as Topic; Diarrhea; Double-Blind Method; Duodenal Ulcer; Duodenoscopy; Female; Headache; Humans; Male; Middle Aged; Misoprostol; Pain; Placebos; Random Allocation

Misoprostol, a synthetic analog of prostaglandin E1, inhibits gastric acid production and is cytoprotective at doses well tolerated by patients in preliminary trials. This multicenter double-blind study was performed in out-patients with endoscopically demonstrated duodenal ulcers, to compare the efficacy in ulcer healing and the safety of two dosages of misoprostol and placebo. Up to six antacid tablets daily were permitted for pain. 308 patients enrolled and were randomized to three treatment groups: placebo, misoprostol 50 micrograms and misoprostol 200 micrograms. After two weeks of treatment, the three groups had similar percentages of patients with complete ulcer healing. However, after four weeks, 76.6% of patients taking misoprostol 200 micrograms q.i.d. had complete healing, compared with 42.6% on misoprostol 50 micrograms q.i.d. and 51% on placebo (P less than 0.001, 200 micrograms versus placebo). Patients taking misoprostol 200 micrograms used less antacid than the others. Diarrhea, mild and self-limiting, was present in 13% of the 200 micrograms group versus 5% on placebo. We conclude that misoprostol 200 micrograms q.i.d. is effective, safe and well tolerated in the treatment of duodenal ulcers.

Topics: Adolescent; Adult; Aged; Alcohol Drinking; Alprostadil; Antacids; Anti-Ulcer Agents; Clinical Trials as Topic; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Drug Interactions; Duodenal Ulcer; Duodenoscopy; Female; Gastric Mucosa; Humans; Male; Middle Aged; Misoprostol; Pain; Random Allocation; Smoking

The primary objective was to compare the efficacy of a single-dose misoprostol for abortion before 7 weeks of gestation and between 7 and 9 weeks of gestation. The secondary objectives were to compare the amount of misoprostol required for complete expulsion, the need for endo-uterine aspiration, and to assess pain and patient experience in these two groups.. This was a single-centre prospective observational study conducted at the University Hospitals of Strasbourg from 1st October 2019 to 31st December 2020.. A total of 306 patients were included, 150 in the group before 7 weeks of gestation and 156 in the group between 7 and 9 weeks of gestation. There was no significant difference in the success rate of the single dose of misoprostol between the two groups with 34.7 and 37.8% respectively (P=0.63). After taking painkillers, there is no difference in terms of pain relief (EN ≤ 4 for 92 et 95% of patients P=0.37).. The single dose of misoprostol for in-hospital abortion is as effective between 7 and 9 weeks of gestation as it is before 7. By extension, therefore, we would suggest that there should be no difference in efficacy between home abortions before 7 weeks of gestation and between 7 and 9 weeks of gestation and therefore suggest that home abortions can be performed up to 9 weeks of gestation without fear of a decrease in the rate of complete expulsion and the efficacy of analgesia, with potentially less use of misoprostol compared with the hospital setting.

Topics: Abortion, Induced; Administration, Intravaginal; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Pain Management; Pregnancy

The aim of the study was to evaluate pain following overnight osmotic cervical dilator placement for second trimester dilation and evacuation (D&E).. A retrospective cohort study surveyed pain and quantified prescription opioid use among 100 women who underwent overnight osmotic cervical dilator placement for D&E. Participants were given opioid and non-steroidal anti-inflammatory (NSAID) prescriptions and were asked to rate their level of pain on a Likert scale (1-10). Demographic and medical information was abstracted from electronic medical records. Bivariate analyses of demographic and clinical characteristics by pain score and opioid use were conducted. Multivariate linear regression analyses were performed for pain score. A multivariate logistic regression model was fitted for factors associated with opioid use.. Gestational age ranged from 14 to 23 weeks (average 19 ± 3 weeks). The mean score of worst pain experienced was 5.3 out of 10. Participants reported 3.4 h of moderate pain (4-6 out of 10) and 1.0 h of severe pain (7-10 out of 10); 54% of women took at least one opioid (mean 2.8 ± 1.5). Multivariate analysis showed that higher pain was associated with younger age (. Most participants with overnight cervical dilators for D&E experienced at least moderate pain and used opioid pain medication in addition to NSAIDs when available. A shared decision-making model may be appropriate for determining which patients may benefit from opioids.

Topics: Abortion, Induced; Analgesics, Opioid; Dilatation; Female; Humans; Infant; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, Second; Retrospective Studies

The Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we provided self-administered medications to eligible women with pregnancies under 12 weeks' gestation.. To assess adherence to the recommended abortion drug regimen, with particular focus on the number of misoprostol doses used and the interval between mifepristone and misoprostol administration and the induction-expulsion interval. Additionally, to evaluate use of analgesia, antiemetics and antibiotics, and the side effects, pain and bleeding profile of medical abortion at home.. We conducted a prospective cohort study of 663 women choosing medical abortion at home via telemedicine at an NHS abortion service in Edinburgh, Scotland between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed at telephone follow-up 4 and 14 days following treatment. Outcome measures were self-reported and included use of mifepristone and misoprostol, induction-expulsion interval (time from misoprostol administration until expulsion of pregnancy), antiemetics, antibiotics, analgesia use, pain scores, rates of side effects, bleeding and preparedness for treatment.. Among the respondents, 652/663 women (98%) answered at least one questionnaire, and 594/663 (89.6%) used both abortion medications as directed (24-72 hours between medications). The mean (SD) induction-expulsion interval was 4.3 (4.3) hours. Antiemetics were used by 611/663 (92%), 383/599 (64%) completed the course of prophylactic antibiotics, and 616/663 (93%) used analgesia, with mean (SD) worst-pain scores of 6.7 (2.2) out of 10. Regarding side effects, 510/663 (77%) experienced either nausea, vomiting, diarrhoea or headache, 101/663 (15%) experienced headache and 510/663 (77%) experienced bleeding that was heavier than a period; 554/663, (84%) felt prepared for their treatment by teleconsultation.. Patients are able to correctly self-administer abortion medications following a telemedicine consultation. Further research is required to optimise pain management and gastrointestinal side effects during medical abortion.

Topics: Abortion, Induced; Anti-Bacterial Agents; Antiemetics; COVID-19; Female; Headache; Humans; Mifepristone; Misoprostol; Pain; Pregnancy; Prevalence; Prospective Studies; Referral and Consultation; Telemedicine; Telephone

Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the most frequently used medications for pain, even though they increase the risk for adverse cardiovascular events.. The objective of this study was to determine cardiovascular, cerebrovascular, and renal event rates between NSAIDs versus NSAIDs plus misoprostol.. A population-based historical cohort of U.S. veterans receiving prescription NSAIDs (1,681,609) versus NSAIDs plus misoprostol (5972 misoprostol users) was followed for 5 years. In an intent-to-treat analysis, NSAID and NSAID plus misoprostol groups were compared using propensity score-weighted Poisson regression models to estimate incident rate ratio (IRR) and Cox regression to estimate hazard ratio (HR).. The most prescribed NSAIDs were diclofenac and ibuprofen. The mean follow-up was 35.2 ± 14.5 months. There were 439 total cardio-renal events (5.62/1000 patient-months) in the NSAID group and 419 patients (5.01/1000 patient-months) in the NSAID plus misoprostol group (Hazard Ratio (HR): 0.89; 95% confidence interval [CI]: 0.78-1.019; p = 0.09). The risk of cardiovascular event was lower in the NSAID plus misoprostol group (HR: 0.56; 95% CI: 0.34-0.93; p < 0.0001). Cerebrovascular event rates were lower in the NSAID plus misoprostol group (HR: 0.74; 95% CI: 0.60-0.94, p < 0.0001) and for renal (HR: 0.67; 95% CI: 0.49-0.89, p < 0.0001) events. All-cause mortality rate was not different between the two groups (HR: 1.05; 95% CI: 0.88-1.25, p = 0.61).. Compared with NSAID use alone, the concomitant use of NSAID plus misoprostol is associated with a reduced risk of NSAID-induced cardiovascular, cerebrovascular, and renal adverse events. These data support the development of a safer NSAID when combined with misoprostol.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; Misoprostol; Pain; Proportional Hazards Models

The aim of this study was to evaluate the pain experience of women induced by intravaginal dinoprostone (Propess®), oral misoprostol (Angusta®) or double balloon catheter (Cook®).. This single-center prospective study was carried out in the obstetric gynecology department of the university hospital of Saint-Etienne from March 2018 to April 2021 in women requiring cervical ripening for the purpose of artificial labor induction.. We included 82 women in the oral misoprostol group, 35 in the vaginal dinoprostone group and 58 in the balloon group. The overall pain, assessed by a numerical scale from 0 to 10, was similar for the different methods of induction (p = 0.253). Pain at insertion was greater with the double balloon catheter compared to the vaginal dinoprostone (3.67 versus 5.75 p = 0.001). Pain in the 2 h prior to the delivery room was greater with vaginal dinoprostone and oral misoprostol compared with the double balloon catheter (7.91 and 7.4 versus 5.47 respectively, p = <0.0001). Women induced by balloon catheter would more often have preferred to be induced by another method compared to those induced by oral misoprostol or vaginal dinoprostone (p = 0.004). Adjusting for previous cesarian section, gestational age at delivery, need for oxytocin augmentation and indication for induction, women induced by balloon were five times more risk to prefer another induction method (OR 5.01 95% CI [1.09-23.03], p = 0.038). There was no significant difference in stress and overall experience of induction depending on the method.. In order to improve the women experience, information, consent and participation in the decisions and choices of their induction method are essential.

Topics: Catheters; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pain; Personal Satisfaction; Pregnancy; Prospective Studies

Topics: Abortifacient Agents, Nonsteroidal; Female; Humans; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, First

Women experience pain during medical abortion, yet optimal pain management remains unclear. We studied the pain experience and need of analgesics during early medical abortion (≤63 days of gestation) among teenage and adult women. We also assessed predictive factors of severe pain.. We recruited 140 primigravid women: 60 teenagers and 80 adult women aged between 25 and 35 years old. The group of teenagers included 19 women under the age of 18 years old (minors). The abortion was performed with mifepristone (200 mg) followed by vaginal misoprostol (800 μg), mainly self-administered at home for adults. Minors were hospitalized during misoprostol administration. Pain medication consisted of ibuprofen 600 mg and paracetamol 1000 mg, first doses taken simultaneously with misoprostol and repeated, if needed, up to three times daily. Additional opiates (mainly tramadol or oxycodone) were administered at hospital if needed. Pain was measured using the visual analogue scale (VAS, 0-100 mm).. The maximal pain VAS (median, interquartile range) was 75 (54-91). Of all the women, 57.7% experienced severe pain (VAS ≥70) during abortion care and 93.5% of women needed additional analgesics in addition to prophylactic pain medication. Teenagers needed additional analgesics more often than adults (5 [3-8] vs 3 [2-6] times, P = .021); 38.0% of all teenagers (64.7% of the minors) received additional opiates compared with 7.9% in adult women. Severe pain (VAS ≥70) was associated with history of dysmenorrhea (adjusted odds ratio [OR] 2.60 [95% confidence interval [CI] 1.21-5.59, P = .014]), anxiety at baseline (2.64 [1.03-6.77], P = .044) and emesis during abortion (5.24 [2.38-11.57], P < .001). Hospital administration of misoprostol did not lower the risk for severe pain experience (OR 0.84 [95% CI 0.34-2.05], P = .694). Satisfaction with care was high in study population (median VAS 91 [interquartile range 79-97]) and was not associated with the use of narcotic analgesic or place of misoprostol administration.. Pain intensity was high both in teenage and adult women undergoing medical abortion, yet satisfaction on care was high. More effective analgesics than ibuprofen and paracetamol should be offered to all women undergoing early medical abortion, especially to those with history of dysmenorrhea. Also, routine use of antiemetics might be advisable.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Acetaminophen; Adolescent; Adult; Analgesics; Drug Therapy, Combination; Drug Utilization Review; Female; Humans; Ibuprofen; Misoprostol; Oxycodone; Pain; Pain Management; Pain Measurement; Pregnancy; Risk Assessment; Tramadol

Although medical abortion with home use of misoprostol has been shown to be safe and acceptable, there are few data about the experience of pain during the procedure. The aims of this study were to assess the intensity of pain associated with home use of misoprostol for medical abortion and to identify variables associated with severe pain.. This was an observational study using an anonymous web-based questionnaire in patients having a medical abortion at home in France between 1 December 2013 and 30 April 2014.. The questionnaire was completed by 232 women and the results of 193 were retained for analysis. The average pain score was 5.6 on a 10 point scale. A pain score ≥6 was rated as severe and was reported by 105 patients (54%). Nulliparity (odds ratio [OR] 4.10; 95% confidence interval [CI] 2.04, 8.22; p < .0001), lack of choice regarding the method of abortion (OR 2.32; 95% CI 1.13, 4.78; p = .0218) and lack of information about the level of pain associated with the procedure (OR 3.27; 95% CI 1.09, 9.74; p = .0334) were significantly correlated with severe pain. Analgesic prescriptions were very heterogeneous.. Pain remains the main side effect of medical abortion. More studies are needed on pain assessment and the effectiveness of analgesic treatments in women using misoprostol at home for medical abortion, in order to improve their care and improve evidence-based guidelines.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Analgesics; Female; France; Humans; Misoprostol; Pain; Pain Measurement; Pregnancy; Self Administration; Surveys and Questionnaires; Young Adult

Topics: Administration, Oral; Adult; Catheterization; Fear; Female; Humans; Internal-External Control; Labor, Induced; Labor, Obstetric; Misoprostol; Oxytocics; Pain; Patient Preference; Pregnancy; Random Allocation; Surveys and Questionnaires; Term Birth; Time Factors; Young Adult

To evaluate the acceptability and efficacy of medical abortion at home up to 63 days' gestation without limits on travel distance to a registered institution.. Observational prospective study.. Haukeland University Hospital between May 2006 and May 2009.. A total of 1018 women requesting abortion before 63 days' gestation who chose medical termination with mifepristone and home administration of misoprostol.. The women took 200 mg mifepristone under nurse supervision and self-administered 800 μg misoprostol vaginally 36-48 h later at home. All were contacted by phone for follow-up and assessment of bleeding, pain and acceptability.. Evacuation rate, pain, bleeding, acceptability, influence of distance on treatment.. Median gestational age was 50 (range 35-63) days and 70 (7.1%) of the women lived more than 60 min travel from the clinic. The rate of completed abortion was 93.6% and surgical evacuation was performed in 50 (4.9%) cases. Two women requested treatment on the day of misoprostol use. Moderate to strong pain was experienced by 68.4%, and 74.7% reported moderate to heavy bleeding. Parous women experienced less pain than nulliparous women (odds ratio 0.27; 95% confidence interval 0.19-0.34). In all, 95.1% of the women were satisfied with staying at home. Travel distance did not influence treatment outcome variables.. In our experience, home administration of misoprostol is an effective and acceptable method for abortion up to 63 days of gestation and women should be eligible for this treatment option regardless of their travel distance from hospital.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Drug Therapy, Combination; Female; Gestational Age; Health Services Accessibility; Humans; Mifepristone; Misoprostol; Odds Ratio; Pain; Patient Acceptance of Health Care; Patient Satisfaction; Pregnancy; Prospective Studies; Self Administration; Travel; Uterine Hemorrhage

Some studies have shown a somatic nociceptive response due to the activation of transient receptor potential A1 channels (TRPA1), which is modulated by the TRPA1 antagonist HC-030031. However, a few studies report the role of TRPA1 in visceral pain. Therefore, we investigated the participation of TRPA1 in visceral nociception and the involvement of nitric oxide, the opioid system and resident cells in the modulation of these channels.. Mice were treated with vehicle or HC-030031 (18.75-300 mg/kg) before ifosfamide (400 mg/kg), 0.75% mustard oil (50 μL/colon), acetic acid 0.6% (10 mL/kg), zymosan (1 mg/cavity) or misoprostol (1 μg/cavity) injection. Visceral nociception was assessed through the electronic von Frey test or the writhing response. Ifosfamide-administered mice were euthanized for bladder analysis. The involvement of nitric oxide and the opioid system were investigated in mice injected with ifosfamide and mustard oil, respectively. The participation of resident peritoneal cells in acetic acid-, zymosan- or misoprostol-induced nociception was also evaluated.. HC-030031 failed to protect animals against ifosfamide-induced bladder injury (p > 0.05). However, a marked antinociceptive effect against ifosfamide, mustard oil, acetic acid, zymosan and misoprostol was observed (p < 0.05). Neither L-arginine (600 mg/kg) nor naloxone (2 mg/kg) could reverse the antinociceptive effect of HC-030031. The reduction of the peritoneal cell population inhibited the acetic acid and zymosan-related writhes without interfering with the misoprostol effect.. Our findings suggest that the blockade of TRPA1 attenuates visceral nociception by a mechanism independent of the modulation of resident cells, nitric oxide and opioid pathways.

Topics: Abdomen; Acetanilides; Animals; Antineoplastic Agents, Alkylating; Cell Count; Colitis; Cystitis; Dinoprostone; Endorphins; Ifosfamide; Inflammation; Male; Mice; Misoprostol; Motor Activity; Mustard Plant; Nitric Oxide; Nociception; Pain; Peritoneal Lavage; Physical Stimulation; Plant Oils; Purines; Transient Receptor Potential Channels; TRPA1 Cation Channel

Topics: Antirheumatic Agents; Arthritis, Rheumatoid; Cooperative Behavior; Deglutition Disorders; Diagnosis, Differential; Diclofenac; Drug Therapy, Combination; Dysphonia; Endoscopy; Female; Folic Acid; Humans; Interdisciplinary Communication; Lymphopenia; Methotrexate; Middle Aged; Misoprostol; Opportunistic Infections; Oral Ulcer; Pain; Pharyngitis; Prednisolone

We studied whether it is possible to predict severity of pain during medical abortion. We also studied how well medical staff recognizes the pain perceived by these women.. Fifty-four women (mean age 26 years, range 18-42 years) undergoing medical abortion before the 64th day of gestation (mean 47 days, range 32-63 days) were asked to estimate their menstrual pain and the pain perceived during medical abortion by visual analogue scale (VAS). Both the intensity and unpleasantness of pain were evaluated separately. The nurses observing the women undergoing medical abortion at the outpatient clinic were asked to estimate by VAS scores their perception of the intensity of pain of the women.. Higher age (magnitude r = -0.30; unpleasantness r = -0.28), increasing number of previous pregnancies (r = -0.34; r = -0.36) and deliveries (r = -0.57; r = -0.60) correlated negatively and advanced gestational length (r = 0.31; r = 0.32) positively with magnitude and unpleasantness of pain evoked by abortion. Twenty-eight (51.8%) of the women were nulliparous. Pain during medical abortion correlates positively (magnitude r = 0.34; unpleasantness r = .0.41) with pain during menstruation. There was no difference between either the intensity or unpleasantness of pain during menstruation and pain during medical abortion. Medical staff accurately assessed the pain women experienced during medication abortion (magnitude r = 0.83; unpleasantness r = 0.79).. Pain during medical abortion correlates with the pain during menstruation. This finding makes counseling of women choosing medical abortion easier and helps in planning the pain relief needed.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adolescent; Adult; Female; Humans; Medical Staff; Mifepristone; Misoprostol; Pain; Pain Measurement; Pregnancy; Statistics, Nonparametric; Surveys and Questionnaires; Young Adult

This prospective observational study evaluated maternal symptoms and characteristics that predict successful labor induction with oral misoprostol.. A total of 244 consecutive women undergoing labor induction voluntarily completed a questionnaire about subjective sensations and pain scores during the induction protocol. Maternal and neonatal characteristics were collected retrospectively from patient files. On the first day of induction, oral misoprostol (50 μg) every 4 h up to three doses was used.. A total of 46% of the parturients delivered or reached the active phase of labor 24 h after the initial dose of misoprostol (ID). In the whole study, 87% of the women delivered vaginally. In multivariable analysis, rupture of membranes, cervical dilatation before the initial dose, maternal sensation of painful contractions at 8 h after the initial dose, and gestational age, were found to be associated with successful labor induction.. Maternal sensation of painful contractions 8 h after an ID is an independent predictive factor of successful labor induction (defined as delivery or active phase of labor 24 h after beginning of induction). Other independent predictive factors are rupture of membranes, cervical dilatation before the initial dose, and gestational age.

Topics: Adult; Extraembryonic Membranes; Female; Gestational Age; Humans; Labor Stage, First; Labor, Induced; Misoprostol; Oxytocics; Pain; Pregnancy; Prospective Studies; Treatment Outcome; Uterine Contraction

The study was aimed to evaluate the effectiveness, outcome, and pain intensity of the vaginal administration of misoprostol for the induction of abortion between 13 and 24 gestational weeks.. A retrospective study was conducted at our tertiary medical center from January 2006 to December 2009 on 122 consecutive women who underwent termination of pregnancy (TOP) in the mid-trimester. They were given 400 mcg of vaginal misoprostol every 6h, up to four doses. The induction-to-abortion interval and the level of pain experienced during the process were assessed. Success was defined by the fetus being expelled within 48 h.. Vaginal misoprostol was effective in 84% (98/122) of patients. The median duration of the induction-to-abortion interval was 16 (5-48)h. The induction-to-abortion interval was correlated with gestational age, while inversely correlated with parity. A correlation was also found between gestational age and pain intensity at 12h from induction.. Misoprostol is safe and effective in mid-trimester abortion induction. The induction-to-abortion interval is shorter and abortion less painful with lower gestational age. Higher parity is also associated with shorter induction to abortion interval.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Intravaginal; Adult; Female; Gestational Age; Humans; Misoprostol; Pain; Pain Measurement; Pregnancy; Pregnancy Trimester, Second; Retrospective Studies; Treatment Outcome; Young Adult

There is a significant need for research on treatments that provide pain relief during intrauterine device (IUD) insertion. Misoprostol is frequently used before IUD insertion but is not always necessary and its use may increase pain and side effects. This survey evaluated how providers who perform IUD insertion in nulliparous women report using misoprostol to facilitate the procedure.. An anonymous Internet-based survey was distributed to members of three professional organizations with family planning providers.. Of 2211 survey respondents, 1905 (86%) reported providing IUDs to nulliparous women. Of those providing IUDs to nulliparous women, 947/1905 (49.7%) reported using misoprostol, and 380 (40%) of 947 of misoprostol users reported using the treatment empirically with all nulliparous IUD insertions. There was wide variation reported in dose, route and timing of misoprostol administration. Providers most commonly reported learning of misoprostol use for IUD insertion by word of mouth rather than through the literature.. Despite conflicting published data, nearly half of survey respondents use misoprostol before IUD insertion. Considerable variation in the timing of misoprostol use may explain differences in perception of its effectiveness. Evidence-based information about misoprostol for IUD insertion in nulliparous women, including pharmacokinetics, efficacy and optimal dosing, is needed.

Topics: Analgesics, Non-Narcotic; Attitude of Health Personnel; Community Health Workers; Female; Health Care Surveys; Humans; Internet; Intrauterine Devices; Misoprostol; Oxytocics; Pain; Pain Measurement; Pilot Projects; Practice Patterns, Physicians'; Time Factors

Topics: Abortifacient Agents, Nonsteroidal; Administration, Inhalation; Administration, Oral; Adolescent; Anesthetics, Local; Bias; Data Interpretation, Statistical; Equipment Safety; Evidence-Based Medicine; Female; Humans; Infant; Labor, Induced; Lidocaine; Misoprostol; Pain; Pregnancy; Randomized Controlled Trials as Topic; Sex Education; Wounds and Injuries

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Age Factors; Amides; Analgesia, Epidural; Analgesia, Obstetrical; Anesthetics, Intravenous; Anesthetics, Local; Female; Humans; Labor, Induced; Mifepristone; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Retrospective Studies; Ropivacaine; Sufentanil

This study has evaluated the anti-inflammatory and analgesic responses of etoricoxib, a selective COX-2 non-steroidal anti-inflammatory drug combined with misoprostol in pre-clinical assays. Groups of animals (mice and rats) were subjected to rat's paw edema induced by carrageenan, and writhing and formalin tests in mice. Treatment with etoricoxib, misoprostol, and etoricoxib combined with misoprostol inhibited the inflammation process by 35 %, 30 %, and 61 %, respectively in the rat paw edema induced by carrageenan with the greatest effects being obtained in the group treated with etoricoxib combined to misoprostol. In the writhing test, etoricoxib inhibited the number of writhes by 33 %, and by 27 % when combined with misoprostol. In the first phase of the formalin test (nociceptive), treatment with the combination of etoricoxib and misoprostol inhibited significantly this process by 45 %, while in the second phase (inflammatory), etoricoxib inhibited this by 97 %, the etoricoxib + misoprostol inhibited this by 78 %, respectively. The responses observed have demonstrated that the combination of etoricoxib and misoprostol increased the anti-inflammatory response, but it did not show effect in the peripheral analgesic response.

Topics: Analysis of Variance; Animals; Anti-Ulcer Agents; Carrageenan; Cyclooxygenase 2 Inhibitors; Drug Evaluation, Preclinical; Drug Synergism; Drug Therapy, Combination; Edema; Etoricoxib; Male; Mice; Misoprostol; Pain; Pain Measurement; Pyridines; Rats; Rats, Wistar; Sulfones

To assess the acceptability of home medical abortion to women in UK settings.. Questionnaire survey.. Four NHS gynaecology units in England and Scotland.. Women undergoing conventional, hospital-based, medical abortion up to nine weeks of gestation.. A self-complete questionnaire explored the acceptability of abortion in hospital (including pain and bleeding experienced) and at home. Comparisons were made between centres (English and Scottish).. Women's views on home administration of misoprostol for medical abortion; perceived acceptability and perceived ability to cope with the process at home.. Sixty-six percent (366/553) of the questionnaires were returned: Edinburgh, 204 (56%); London, 92 (25%); Hull, 43 (12%); and Glasgow, 27 (7%). Individual questionnaire items were answered by varying numbers of women: 228/320 (71%; 95% CI: 66-76%) said there was nothing that happened during abortion in the hospital that they would have been unable to cope with at home; 123/342 (36%; 95% CI: 31-41%) said they would have opted to have home abortion, had that choice been available. However, 219/342 (64%; 95% CI: 59-69%) indicated that they would prefer to have abortion in the hospital. The majority of women said they would have coped at home with bleeding (280/355, 79%; 95% CI: 74-83%) and with pain if given analgesia (203/268, 76%; 95% CI: 70-81%).. This study suggests that most women would welcome being offered the choice of having medical abortion at home or in hospital. The development of home abortion must be seen as complementary, not an alternative, to hospital services.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Attitude to Health; England; Female; Home Care Services; Humans; Misoprostol; Pain; Patient Satisfaction; Postpartum Hemorrhage; Pregnancy; Scotland; Surveys and Questionnaires

To evaluate the success rate of medical abortion using an outpatient regimen of oral mifepristone 400 mg and oral misoprostol 400 microg for legal abortion in women < 56 days pregnant.. Successful abortion was defined as an endometrial thickness < 20 mm evaluated by transvaginal ultrasound and minimal vaginal bleeding at a control examination performed 14 days after administration of misoprostol. Over a 6-month period in 2003, a questionnaire (completion rate 70%) was used for a spot check of the patients' evaluation of the method.. Six hundred and sixty women underwent the procedure over a 3-year period and 606 (92%) experienced successful medical abortion. The remaining 8% had vacuum aspiration performed mainly due to uterine retention (70%). Other reasons were vaginal bleeding (25%), vomiting (2%), or pelvic infection (4%). Most women reported no days with severe pain (67%), 0--1 days with moderate pain (82%), and 0--1 days with light pain (62%). In terms of gastrointestinal side effects, 68% reported nausea, 33% vomiting, and 27% diarrhea. Most women (90%) felt that the information given at the hospital prior to the abortion was sufficient, 74% would prefer medical abortion again in case of a future unwanted pregnancy, and 85% would prefer to abort at home again.. A high acceptance and success rate was seen using this outpatient oral regimen of mifepristone and misoprostol.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Administration, Oral; Female; Follow-Up Studies; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, First; Surveys and Questionnaires; Time Factors; Treatment Outcome

To assess analgesia use and the predictors for requiring analgesia in women undergoing medical abortion at all gestations up to 22 weeks.. Retrospective observational study.. Aberdeen Royal Infirmary, Scotland.. Consecutive women undergoing medical abortion under the terms of the 1967 Abortion Act.. Analgesia requirements and characteristics of women undergoing abortion were analysed using logistic regression.. The effect of age, gestation, reproductive history, route and dose of misoprostol administration on analgesia requirements.. Of the total 4343 women included in this review, 3139 women (72%) required analgesia. Of these, 3054 women (97%) used oral analgesia, 75 women (2.4%) used opiates while 10 women (0.3%) had diclofenac sodium given rectally. There was no significant difference in analgesia use whether women used the vaginal or sublingual route of misoprostol administration. Logistic regression showed a significant positive association with gestation at termination (odds ratio [OR] 1.09, 95% confidence interval [CI] 1.05-1.12), number of misoprostol doses used (OR 1.31, 95% CI 1.13-1.51) and induction to abortion interval (OR 1.08, 95% CI 1.03-1.12) and a negative association with the age of women undergoing abortion (OR 0.98, 95% CI 0.97-0.99) and previous live birth (OR 0.43, 95% CI 0.33-0.56).. Analgesia requirement was significantly higher in women of younger age, higher gestation, longer induction to abortion interval and with increased number of misoprostol doses used while women with previous live birth were significantly less likely to use analgesia.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Analgesia; Analgesia, Obstetrical; Analgesics; Female; Humans; Mifepristone; Misoprostol; Pain; Pregnancy; Pregnancy Trimester, Second; Regression Analysis; Retrospective Studies

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

Although serious adverse events of early abortion have been studied, little attention has been paid to the more common side effects experienced by early medical or surgical abortion clients. Using data from a multicenter comparative trial of women < or = 56 days' gestation in China, Cuba, and India (n = 1373), side effects experienced by mifepristone-misoprostol medical abortion and surgical abortion clients were analyzed at the different stages of their abortions. Data on side effects came from women's reports at each clinic visit, providers' observations during the clinic visits, and symptom diaries maintained during the study period. Medical abortion clients at all sites experienced more side effects than their surgical counterparts. The disparity between the two groups was particularly pronounced for bleeding and pain. Despite more reports of side effects among medical abortion clients, however, assessments of well-being and reports of satisfaction at the exit interview were similar in both treatment groups.

Topics: Abortifacient Agents; Abortion, Induced; Abortion, Legal; Adult; China; Cuba; Drug Therapy, Combination; Female; Hemorrhage; Humans; India; Mifepristone; Misoprostol; Pain; Pregnancy

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Missed; Female; Humans; Mifepristone; Misoprostol; Pain; Pregnancy; Uterine Hemorrhage

The effectiveness of a combined regimen of mifepristone and vaginal misoprostol for termination of pregnancies of 9-13 weeks of gestation was investigated in 120 UK abortion patients (median age, 22.1 years; median duration of amenorrhea, 10.3 weeks). Each woman received a single oral dose of 200 mg of mifepristone 36-48 hours before admission, at which time 800 mcg of misoprostol was administered vaginally. Where indicated, a further two doses of 400 mcg of misoprostol (vaginal or oral) were provided every 3 hours. All 120 women aborted on the day of prostaglandin administration; however, 6 women (5%) required exploratory curettage after the procedure for retained placenta. The median prostaglandin dose was 1200 mcg (range, 800-1600 mcg). The median time from misoprostol administration to abortion was 4.33 hours (range, 1.3-16.0 hours). 60 women (50%) required oral analgesics and 26 (22%) received parenteral analgesia. Diarrhea occurred in 38 women (32%). The median duration of bleeding after abortion was 12.5 days (range, 3-43 days). In questionnaires administered to 73 women, only 3 (4%) expressed dissatisfaction with medical abortion, because of pain or prolonged bleeding. The relatively high dose of misoprostol used in this study and the vaginal route of administration are presumed to account for the 95% success rate. Extension of medical abortion to later gestation times would decrease the need for surgery and expand women's choice of methods of pregnancy termination.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Intravaginal; Administration, Oral; Adolescent; Adult; Analgesics; Diarrhea; Female; Follow-Up Studies; Gestational Age; Humans; Mifepristone; Misoprostol; Pain; Patient Satisfaction; Pregnancy; Pregnancy Trimester, First; Uterine Hemorrhage; Vomiting

The present study compared the effect of acetaminophen, ibuprofen and misoprostol on PGE2 synthesis and orthodontic tooth movement. Guinea pigs were randomly assigned into one of three test groups or a control group. Each group received study treatments every 12 hours as an orthodontic force was applied to the maxillary incisors. Direct linear measurements of tooth separation were recorded at days 2, 4, 6, 10, and 11, and inflammatory exudate from the periodontal ligament (PDL) space was extracted and quantitatively analyzed radioimmunologically for the presence of PGE2 at days 4 and 9. Comparing the concentration of PGE2 in sample extracts, a significant difference (P = 0.001) was found among drug groups. A highly significant difference was found between the mean tooth separation among the various drug groups (P < 0.001). At day 11 the misoprostol group exhibited 4.49 +/- 0.49 mm of separation; ibuprofen 2.56 +/- 0.11 mm, and the control and acetaminophen groups exhibited similar degrees of tooth separation: 3.31 +/- 0.07 mm and 3.31 +/- 0.08 mm, respectively. A highly significant difference occurred between the mean rates of tooth separation among the various drug groups after day 8 (P < 0.001). Results of this study suggest that acetaminophen is the analgesic of choice for the relief of minor discomfort associated with orthodontic treatment.

Topics: Acetaminophen; Analgesics, Non-Narcotic; Analysis of Variance; Animals; Anti-Inflammatory Agents, Non-Steroidal; Dinoprostone; Gingival Crevicular Fluid; Guinea Pigs; Ibuprofen; Incisor; Male; Maxilla; Misoprostol; Orthodontic Appliances; Oxytocics; Pain; Periodontal Ligament; Random Allocation; Tooth Movement Techniques