Abortion Failure Clinical Trial
Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial
|Source||Gynuity Health Projects|
|Contact||Ilana Dzuba, MHS|
|Start date||June 2016|
|Completion date||October 2018|
The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.
This is a multi-site double-blind, randomized controlled trial to assess treatment with a
repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in
women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up
after medical abortion. The sample will be stratified in two cohorts: women with ongoing
pregnancies <= 56 days of gestation and women with ongoing pregnancies 57-77 days of
gestation. Eligible women who agree to participate in the study will be randomly assigned to
either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg
buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2
for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol
24-48 hours later and another 800 mcg dose repeated in 3-12 hours.
The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment