Mifepristone pretreatment followed by misoprostol 200mcg buccal for the medical management of intrauterine fetal death at 14-28 weeks: A randomized, placebo-controlled, double blind trial
- March 16th, 2020
- Staff Publication
- Pregnancy Failure and Miscarriage
- Bracken, H., Ngoc, N.T.N., Ha, D.Q., Paredes, N.R., Quyet, V.B., Linh, N.T.H., Ortiz, M,A,, Bousieguez, M., Winikoff, B.
Bracken H, Ngoc NTN, Ha DQ, Paredes NR, Quyet VB, Linh NTH, Ortiz MA, Bousieguez M, Winikoff B. "Mifepristone pretreatment Followed by Misoprostol 200mcg Buccal for the Medical Management of Intrauterine Fetal Death at 14-28 Weeks: A Randomized, Placebo-controlled, Double Blind Trial" Contraception (March 2020) doi:10.1016/j.contraception.2020.02.007 [Epub ahead of print]
To evaluate whether fetal and placental expulsion is more likely within 48 hours if women receive mifepristone pre-treatment versus placebo pre-treatment followed by misoprostol 200mcg buccally for treatment of fetal death at 14 weeks 0 days to 28 weeks and 6 days gestation.
Study Design: 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 hours later all participants received misoprostol 200 mcg buccally every 3 hours for up to 16 doses or 48 hours.
Complete expulsion of the fetus and placenta within 48 hours 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 hours versus ±5 vs 12 ±13 hours; p<0.001). Women in the mifepristone-misoprostol group were more likely to expel the fetus within 24 hours of the start of misoprostol administration (96% versus 78%; RR 1.22 (1.09-1.39) p=0.009).
Mifepristone-misoprostol did not result in a higher rate of complete expulsion of the fetus and the placenta within 48 hours of the start of misoprostol administration without any additional surgical intervention or medication (e.g. additional misoprostol doses or oxytocin) than placebo-misoprostol. However, treatment with mifepristone-misoprostol did result in a shorter time to expulsion than placebo misoprostol.
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