Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss

Abstract

BACKGROUNDMedical management of early pregnancy loss is an alternative to uterine aspira-tion, but standard medical treatment with misoprostol commonly results in treat-ment failure. We compared the efficacy and safety of pretreatment with mifepris-tone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss. METHODSWe randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, administered orally, followed by 800 µg of misoprostol, adminis-tered vaginally (mifepristone-pretreatment group), or 800 µg of misoprostol alone, administered vaginally (misoprostol-alone group). Participants returned 1 to 4 days after misoprostol use for evaluation, including ultrasound examination, by an in-vestigator who was unaware of the treatment-group assignments. Women in whom the gestational sac was not expelled were offered expectant management, a second dose of misoprostol, or uterine aspiration. We followed all participants for 30 days after randomization. Our primary outcome was gestational sac expulsion with one dose of misoprostol by the first follow-up visit and no additional intervention within 30 days after treatment. RESULTSComplete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8 to 89.3) in the mifepristone-pretreat-ment group and in 100 of 149 women (67.1%; 95% CI, 59.0 to 74.6) in the miso-prostol-alone group (relative risk, 1.25; 95% CI, 1.09 to 1.43). Uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21 to 0.68). Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P = 0.31); pelvic infection was diagnosed in 1.3% of the women in each group. CONCLUSIONSPretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone. (Funded by the National Institute of Child Health and Human Development; PreFaiR ClinicalTrials.gov number, NCT02012491.) Disciplines Medicine and Health Sciences

Efficacy of mifepristone and misoprostol for medical treatment of missed miscarriage in clinical practice—A cohort study

“…We found uterine size exceeding 9 weeks of gestation to be the only predictive factor for surgical intervention. Our results are confirmed by Schreiber et al, who could not identify factors predictive of treatment success …”

“…In the study by Schreiber et al, 2% of women in the mifepristone group required blood transfusion. However, fewer women than in our study required surgical intervention . The disadvantages of surgical intervention must be weighed against risk with blood transfusion.…”

“…Wagaarachchi et al included 220 women and reported a success rate of 84.1% for the same dosages with repeated misoprostol, but used vaginal administration for all doses and higher and repeated dosages of misoprostol for incomplete miscarriage. A randomized controlled study of mifepristone pretreatment before treatment with misoprostol was recently published . In this study, women received a single vaginal dose of 800 µg misoprostol.…”

“…However, studies on mifepristone as pretreatment in medical treatment of missed miscarriage have generated conflicting results . Recently, a randomized trial compared pretreatment with mifepristone to misoprostol only treatment . It showed superiority of the combined treatment with 8.8% of women in the combined arm needing vacuum aspiration.…”

Comparison of mifepristone plus misoprostol with misoprostol alone for first trimester medical abortion: A systematic review and meta-analysis

“…The rate of successful abortion was also reported to vary with the timing of subsequent misoprostol administration following mifepristone (30). The systematic reviews conducted so far have significant variations in terms of the designs employed, drugs considered, target population factors, as well as statistical measures applied by original studies, consequently ending with diverse conclusions (31,32).…”