A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy.

Objective: To assess differences in outcomes of misoprostol with or without mifepristone for second-trimester abortion.

Methods: A randomized, double-blind, placebo-controlled trial of buccal misoprostol following placebo or 200mg mifepristone was done in Tunisia among women presenting for abortions at 14-21 weeks of pregnancy between August 2009 and December 2011. Women with a live fetus, a closed cervical os, no cervical bleeding, and no contraindications to study drugs were eligible and underwent randomization (block size 10).

Acceptability and feasibility of mifepristone-misoprostol for menstrual regulation in Bangladesh.

Context: Annually, more than 700,000 women turn to menstrual regulation, or uterine evacuation with vacuum aspiration; many more resort to unsafe abortion. Using pills for the evacuation of the uterus could increase women's access to safe menstrual regulation services and reduce the high levels of abortion- and menstrual regulation- related morbidity in Bangladesh.

Methods: At 10 facilities in Bangladesh, 651 consenting women who were seeking menstrual regulation services and who were 63 days or less past their last menstrual period received 200 mg of mifepristone followed 24 hours later by 800 mcg of buccal misoprostol, administered either at home or in the clinic.

Efficacy and acceptability of early mifepristone-misoprostol medical abortion in Ukraine: results of two clinical trials.

Background: Abortion services are legally available in Ukraine although there are issues in quality and access. Two studies were conducted in Ukraine to expand options for women, and to determine the efficacy and acceptability of medical abortion.

Study Design: Two open-label clinical trials were conducted at six clinics in Ukraine.

Acceptability and feasibility of the use of 400 μg of sublingual misoprostol after mifepristone for medical abortion up to 63 days since the last menstrual period: evidence from Uzbekistan.

Objective: To examine the efficacy, acceptability and feasibility of early medical abortion, with the option of home administration of misoprostol, in Uzbekistan.

Methods: A total of 450 women were enrolled at national, municipal and private facilities in Tashkent, Uzbekistan. Women who presented for termination of pregnancy with gestations up to 63 days were recruited to participate in the study.

Misoprostol for the management of postpartum bleeding: a new approach.

Excessive postpartum hemorrhage (PPH) is a leading cause of maternal death globally. Current approaches to address PPH at the community level focus on reducing the incidence of PPH, but often fail to address the issue of PPH treatment. Given that institutional delivery is not yet a reality for all women, comprehensive care for excessive bleeding after delivery needs to be available at the community level.

Misoprostol for prevention and treatment of postpartum hemorrhage: what do we know? What is next?

Misoprostol is an effective and safe uterotonic for the prevention and treatment of postpartum hemorrhage (PPH). A 600-μg oral dose of misoprostol has been shown to prevent PPH in community-based randomized controlled trials. An 800-μg sublingual dose of misoprostol appears to be a good first-line treatment for controlling PPH.

Clinic-level introduction of medical abortion in Vietnam.

Objective: To assess the efficacy of medical abortion and patient satisfaction in the clinic setting, in addition to determining healthcare providers' views.

Methods: From 2006 to 2008, 2400 women were enrolled at 10 Vietnam Family Planning Association (VINAFPA) clinics in an operations research project. Participants took 200mg of oral mifepristone in the clinic and 400 μg of oral misoprostol 2 days later at home or in the clinic.

Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam.

Objective: To assess the potential advantages of combined mifepristone-misoprostol versus misoprostol-only for early medical abortion.

Methods: A double-blind randomized placebo controlled study was conducted that enrolled 441 pregnant women (<63 days since last menstrual period) at 2 hospitals in Tunisia and Vietnam. The mifepristone-misoprostol group (n=220) received 200mg of mifepristone on day 1 and 800 μg buccal misoprostol followed by placebo 3 hours later on day 2.

Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial.

Objective: To estimate the clinical benefit of pretreatment with mifepristone followed by misoprostol compared with misoprostol alone for second-trimester abortion.

Methods: Two hundred sixty women with live fetuses of gestational ages 14-21 weeks were enrolled in a randomized, placebo-controlled, double-blind trial in Vietnam. Eligible consenting women received either mifepristone or placebo to take on their own at home and were scheduled to return to the hospital the next day.

Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone.

Background: Nonsurgical abortion methods have the potential to improve access to high-quality abortion care. Until recently, availability and utilization of mifepristone medical abortion in low-resource countries were restricted due to the limited availability and perceived high cost of mifepristone, leading some providers and policymakers to support use of misoprostol-only regimens. Yet, this may not be desirable if misoprostol-only regimens are considerably less effective and ultimately more costly for health care systems.

Comparison of 400 mcg buccal and 400 mcg sublingual misoprostol after mifepristone medical abortion through 63 days' LMP: a randomized controlled trial.

Background: Buccal misoprostol 800 mcg and sublingual misoprostol 400 mcg demonstrate high efficacy and few adverse effects when used with 200 mg mifepristone for medical abortion through 63 days since the last menstrual period (LMP). Little is known about a 400-mcg buccal dose. This study compares two in-the-mouth routes of misoprostol using the same dose.

Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial.

Background: Oxytocin, the gold-standard treatment for post-partum haemorrhage, needs refrigeration, intravenous infusion, and skilled providers for optimum use. Misoprostol, a potential alternative, is increasingly used ad hoc for treatment of post-partum haemorrhage; however, evidence is insufficient to lend support to recommendations for its use. This trial established whether sublingual misoprostol is non-inferior to intravenous oxytocin for treatment of post-partum haemorrhage in women receiving prophylactic oxytocin.

Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial.

Background: Oxytocin, the standard of care for treatment of post-partum haemorrhage, is not available in all settings because of refrigeration requirements and the need for intravenous administration. Misoprostol, an effective uterotonic agent with several advantages for resource-poor settings, has been investigated as an alternative. This trial established whether sublingual misoprostol was similarly efficacious to intravenous oxytocin for treatment of post-partum haemorrhage in women not exposed to oxytocin during labour.

Two routes of administration for misoprostol in the treatment of incomplete abortion: a randomized clinical trial.

Background: This study was conducted to compare the safety, effectiveness and acceptability of 400 mcg sublingual misoprostol and 600 mcg oral misoprostol for treatment of incomplete abortion.

Study Design: We used an open-label randomized controlled trial conducted from July 2005 to August 2006 in a large tertiary level maternity hospital in Antananarivo, Madagascar, and a large tertiary level hospital in Chisinau, Moldova. Three hundred consenting women seeking treatment for clinically diagnosed incomplete abortion with uterine size View Article and Find Full Text PDF

Two-pill regimens of misoprostol after mifepristone medical abortion through 63 days' gestational age: a randomized controlled trial of sublingual and oral misoprostol.

Background: A 400 mcg dose of sublingual misoprostol has high efficacy and few side effects when used with 200 mg mifepristone for medical abortion through 63 days' gestation.

Study Design: Eligible and consenting women (n=480) were randomized to 400 mcg of misoprostol sublingually or orally, 24 h after 200 mg of mifepristone. Abortion status was assessed two weeks later.