Mifepristone pretreatment followed by misoprostol 200 mcg buccal for the medical management of intrauterine fetal death at 14–28 weeks: A randomized, placebo-controlled, double blind trial

• Published in: Contraception (Stoneham) 2020-07, Vol.102 (1), p.7-12
• Main Authors: Bracken, Hillary, Ngoc, Nguyen thi Nhu, Ha, Do Quan, Paredes, Norberto Reyes, Quyet, Vu Ba, Linh, Nguyen Thi Huyen, Ortiz, Marco Antonio, Bousieguez, Manuel, Winikoff, Beverly
• Format: Article
• Language: English
• Subjects: Fetal death; Mifepristone; Misoprostol
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2020.02.007

To evaluate whether fetal and placental expulsion is more likely within 48 h if women receive mifepristone pre-treatment vs placebo pre-treatment followed by misoprostol 200 mcg buccally for treatment of fetal death at 14 weeks 0 days to 28 weeks and 6 days gestation. We randomized 176 women with a confirmed fetal death between 14 weeks and 0 days to 28 weeks and 6 days to mifepristone 200 mg or placebo; 24 h later all participants received misoprostol 200 mcg buccally every 3 h for up to 16 doses or 48 h. The trial took place in Hanoi, Vietnam and Mexico City in 2015–2018. Complete expulsion of the fetus and placenta within 48 h of misoprostol administration occurred in 74 of 90 women (82.2%, 95% confidence interval (CI), 72.7%-89.5%) in the mifepristone-misoprostol group and in 70 of 86 women (81.4%, 95% CI, 71.6%–89.0%) in the placebo-misoprostol group (Relative Risk (RR) 1.01, 95%CI 0.87–1.16, p = 0.887). The median time from the start of the misoprostol induction to fetal expulsion was shorter among women who received mifepristone–misoprostol compared to women assigned to placebo-misoprostol (7 h vs ±5 vs 12 ± 13 h; p