Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Completed 120 enrolled Gynuity Health Projects

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Timeline

Start: 2008-08
Primary completion: 2009-08
Completion: 2009-08

Outcome

Met primary endpoint

paper Pretreatment with mifepristone resulted in more than twice the chance of complete uterine evacuation in 15 hours (79.8% compared with 36.9%, relative risk 2.16, 95% confidence interval 1.70-2.75). PMID 21860289 ↗

Publications

Ngoc NTN, Shochet T, Raghavan S, Blum J, Nga NTB, Minh NTH, Phan VQ, Winikoff B. Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):601-608. doi: 10.1097/AOG.0b013e318227214e.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mifepristone	Small molecule	200 mg	—
Background	Misoprostol	Other / unclassified	800 ug	Other

Indications

No indication recorded.