Continuation of pregnancy after first‐trimester exposure to mifepristone: an observational prospective study

Abstract

Objective To report the follow-up of continuing pregnancies after first-trimester exposure to mifepristone.Design Observational prospective study.Setting France.Sample Patients exposed to mifepristone during the first 12 weeks of pregnancy.Methods Women were included in the study when they or their doctors asked a French pharmacovigilance centre or the Paris Teratogen Information Service about the risk of mifepristone exposure in early pregnancy. Exclusion criteria were requests received after 22 weeks of gestation or subsequent elective termination of pregnancy without a pathological examination of the fetus. Data on maternal history and drug exposure were collected on first contact, and pregnancy outcomes were documented at follow-up.Main outcome measures Rate of major congenital malformations.Results A total of 105 pregnancies were included, with 46 exposed to mifepristone alone, and 59 exposed to both mifepristone and misoprostol. There were 94 live births (90.4%) and 10 (9.6%) miscarriages (including one with major malformation). Elective termination of pregnancy was performed after the subsequent diagnosis of trisomy 21 in one case. The overall rate of major congenital malformations was 4.2% (95% CI 1.2-10.4%), with two cases among 38 patients exposed to mifepristone alone, and two cases among 57 patients exposed to both mifepristone and misoprostol.Conclusions This first prospective study found that the rate of major malformations after first-trimester exposure to mifepristone is only slightly higher than the expected 2-3% rate in the general population. Such findings provide reassuring data for risk evaluation for continuation of pregnancy after mifepristone exposure.

Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: a systematic review

“…A recent prospective study from France reported on 46 pregnancies exposed to mifepristone only [28]. Two major malformations occurred among 38 continuing pregnancies (5.3%), which, based on these small numbers, does not appear to be significantly elevated above the expected proportion of about 3%.…”

First series of 18 pregnancies after ulipristal acetate treatment for uterine fibroids

“…Hormone intake by the mother has not been described to have an influence on renal morphogenesis, which seems to be a self-regulating process involving complex molecular mechanisms and gene regulation during fetal life (21,22). In addition, a review of pregnancies after exposure to mifepristone (given to induce abortion) or UPA (given for emergency contraception), respectively, shows no additional risk of congenital anomalies (23,24). The baby showed no renal function anomaly and no signs of vesicoureteral reflux.…”

Medication Abortion Up to 70 Days of Gestation

“…Most individuals with a continuing pregnancy opt to complete the abortion, but patients should be supported in their choice of how to proceed. No evidence exists to date of a teratogenic effect of mifepristone [34]. However, misoprostol can result in congenital anomalies, such as limb defects with or without Möbius' syndrome (ie, facial paralysis), when used during the first trimester [35][36][37][38][39].…”