Non-surgical Alternatives to Treatment of Failed Medical Abortion

NCT02704481 | Terminated Phase 4 DMC

• 1 other identifier: 1035
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 14

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.

Conditions

Abortion Failure

Keywords

mifepristone; misoprostol; medical abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Mifepristone-misoprostol

EXPERIMENTAL

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.

Drug: Mifepristone; Drug: Misoprostol; Drug: Placebo misoprostol

Misoprostol-misoprostol

EXPERIMENTAL

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.

Drug: Misoprostol; Drug: Placebo mifepristone

Interventions

Mifepristone DRUG

200mg oral mifepristone

Also known as: Mifeprex

Mifepristone-misoprostol

Misoprostol DRUG

800mcg buccal misoprostol

Also known as: Cytotec

Mifepristone-misoprostol; Misoprostol-misoprostol

Placebo mifepristone DRUG

Matching placebo pill of 200mg mifepristone

Misoprostol-misoprostol

Placebo misoprostol DRUG

Matching placebo pills of 800mcg misoprostol

Mifepristone-misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (14)

Planned Parenthood of Northern California

Concord, California, 94520, United States

Location

Planned Parenthood of the Pacific Southwest

San Diego, California, 92108, United States

Location

Planned Parenthood of the Rocky Mountains

Denver, Colorado, 80207, United States

Location

Presidential Women's Center

West Palm Beach, Florida, 33407, United States

Location

Planned Parenthood of Illinois

Chicago, Illinois, 60603, United States

Location

Family Planning Associates Medical Group, Ltd.

Chicago, Illinois, 60661, United States

Location

Planned Parenthood of the Heartland

Des Moines, Iowa, 50305, United States

Location

Emma Goldman Clinic

Iowa City, Iowa, 52245, United States

Location

Planned Parenthood of Northern New England

Topsham, Maine, 04086, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Planned Parenthood of Mid and South Michigan

Ann Arbor, Michigan, 48108, United States

Location

Northland Family Planning Clinic Inc.

Westland, Michigan, 48185, United States

Location

Planned Parenthood of Central and Greater Northern New Jersey

Morristown, New Jersey, 07960, United States

Location

Montefiore Family Health Center

The Bronx, New York, 10458, United States

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ilana Dzuba, MHS

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Tara Shochet, PhD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 10, 2016
• Study Start: June 1, 2016
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)