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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
200mg oral mifepristone
800mcg buccal misoprostol
Matching placebo pill of 200mg mifepristone
Planned Parenthood of Northern California
Concord, California, United States
Planned Parenthood of the Pacific Southwest
San Diego, California, United States
The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason.
Time frame: One week after taking first study medication
The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
Time frame: One week after taking first study medication
The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
Time frame: One week after taking first study medication
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Matching placebo pills of 800mcg misoprostol
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States
Presidential Women's Center
West Palm Beach, Florida, United States
Planned Parenthood of Illinois
Chicago, Illinois, United States
Family Planning Associates Medical Group, Ltd.
Chicago, Illinois, United States
Planned Parenthood of the Heartland
Des Moines, Iowa, United States
Emma Goldman Clinic
Iowa City, Iowa, United States
Planned Parenthood of Northern New England
Topsham, Maine, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
...and 4 more locations