Non-surgical Alternatives to Treatment of Failed Medical Abortion

Phase 4

Terminated

• Conditions: Abortion Failure
• Interventions: Drug: Misoprostol; Drug: Mifepristone; Drug: Placebo mifepristone; Drug: Placebo misoprostol

• Registration Number: NCT02704481
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-10
• Study Start: 2016-06-01
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) <= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy
• Agree to comply with study procedures
• Able to consent to study participation

Exclusion Criteria

• Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site
• Are < 18 years old in US and Canadian sites
• Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac
• Are unable to provide contact information for follow-up purposes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone-misoprostol	Placebo misoprostol	Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later.
Misoprostol-misoprostol	Misoprostol	Women randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose.
Misoprostol-misoprostol	Placebo mifepristone	Women randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose.
Mifepristone-misoprostol	Mifepristone	Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later.
Mifepristone-misoprostol	Misoprostol	Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later.

Primary Outcome Measures

Name	Time	Method
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.	One week after taking first study medication

Secondary Outcome Measures

Name	Time	Method
The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire	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	One week after taking first study medication

Trial Locations

Locations (14)

Planned Parenthood of Northern California; 🇺🇸 Concord, California, United States

Presidential Women's Center; 🇺🇸 West Palm Beach, Florida, United States

Family Planning Associates Medical Group, Ltd.; 🇺🇸 Chicago, Illinois, United States

Planned Parenthood of the Pacific Southwest; 🇺🇸 San Diego, California, United States

Planned Parenthood of Illinois; 🇺🇸 Chicago, Illinois, United States

Planned Parenthood of Northern New England; 🇺🇸 Topsham, Maine, United States

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States

Emma Goldman Clinic; 🇺🇸 Iowa City, Iowa, United States

Northland Family Planning Clinic Inc.; 🇺🇸 Westland, Michigan, United States

Planned Parenthood of Central and Greater Northern New Jersey; 🇺🇸 Morristown, New Jersey, United States

Planned Parenthood of the Rocky Mountains; 🇺🇸 Denver, Colorado, United States

Planned Parenthood of the Heartland; 🇺🇸 Des Moines, Iowa, United States

Planned Parenthood of Mid and South Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Montefiore Family Health Center; 🇺🇸 Bronx, New York, United States