Mifepristone and misoprostol compared with misoprostol alone for induction of labor in intrauterine fetal death: A randomized trial

Abstract

Aim: To assess whether mifepristone and misoprostol are more beneficial than misoprostol alone for the induction of labor in women with intrauterine fetal death. Methods: A randomized double blind placebo-controlled parallel group superiority trial was conducted. One hundred and ten women who had experienced fetal death at or later than 20 weeks of gestation were randomized by computer-generated random number sequence to receive 200 mg of mifepristone or matched placebo tablets orally. Misoprostol was administered vaginally to women of both groups after 36-48 h. The main outcomes studied were the fetal-placental delivery rate within 24 hours of commencement of the first dose of misoprostol without additional intervention and the induction-delivery interval. Results: Successful delivery occurred significantly more frequently in women who received mifepristone prior to misoprostol than in women who received only misoprostol (92.5 % [49/53] compared with 71.2% [37/52] respectively; P = 0.001). The mean induction-delivery interval was also significantly shorter when using mifepristone plus misoprostol than using misoprostol alone (9.8 h, standard deviation, 4.4 compared with 16.3 h standard deviation, 5.7, respectively; P < 0.001). Conclusion: Use of a combination of mifepristone and misoprostol significantly improved the rate of successful delivery and shortened the induction-delivery interval in women who had experienced fetal death compared with the use of misoprostol alone.

A systematic review of the effectiveness, safety, and acceptability of medical management of intrauterine fetal death at 14–28 weeks of gestation

“…No direct evidence related to medical management compared with surgical, expectant, or placebo management was identified. Four trials reported that the analysis was intention‐to‐treat (ITT) analysis . Thus, it was not possible to perform true ITT analyses for all comparisons and outcomes.…”

“…Four trials reported that the analysis was intention-to-treat (ITT) analysis. 18,20,23,24 Thus, it was not possible to perform true ITT analyses for all comparisons and outcomes.…”

“…We contacted the authors of included trials where additional information was needed. We received information from four trial authors, with two providing disaggregated IUFD data . The flow of included and excluded trials is presented in Figure .…”

“…One trial compared mifepristone and misoprostol versus misoprostol alone . Misoprostol was administered vaginally every 6 hours.…”

Induction of Labour With Vaginal Misoprostol in Intrauterine Foetal Death

“…El Gharib et al 10 has recorded 90% and 45% success rate in the third and second trimester foetal deaths respectively. Chaudhari P et al 12 have achieved 92.5% and 71.2% success rates in their study which compared use of misoprostol with or without mifepristone respectively. P value being 0.001, which was significant.…”