Non-surgical Alternatives to Treatment of Failed Medical Abortion

NCT ID: NCT02704481

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-01-16

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.

Conditions

Abortion Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mifepristone-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.

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

200mg oral mifepristone

Misoprostol

Intervention Type: DRUG

800mcg buccal misoprostol

Placebo misoprostol

Intervention Type: DRUG

Matching placebo pills of 800mcg 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.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

800mcg buccal misoprostol

Placebo mifepristone

Intervention Type: DRUG

Matching placebo pill of 200mg mifepristone

Interventions

Mifepristone

200mg oral mifepristone

Intervention Type: DRUG

Misoprostol

800mcg buccal misoprostol

Intervention Type: DRUG

Placebo mifepristone

Matching placebo pill of 200mg mifepristone

Intervention Type: DRUG

Placebo misoprostol

Matching placebo pills of 800mcg misoprostol

Intervention Type: DRUG

Other Intervention Names

Mifeprex; Cytotec

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilana Dzuba, MHS

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Tara Shochet, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

Planned Parenthood of Northern California

Concord, California, United States

Planned Parenthood of the Pacific Southwest

San Diego, California, United States

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

Planned Parenthood of Mid and South Michigan

Ann Arbor, Michigan, 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

Montefiore Family Health Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

1035

Identifier Type: -

Identifier Source: org_study_id