Non-surgical Alternatives to Treatment of Failed Medical Abortion

Abortion Failure Clinical Trial

Official title:

Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02704481
• Other study ID #: 1035
• Status: Terminated
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: January 16, 2019

Study information

• Verified date: July 2021
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion Failure

Intervention

Drug:
• Mifepristone
200mg oral mifepristone
• Misoprostol
800mcg buccal misoprostol
• Placebo mifepristone
Matching placebo pill of 200mg mifepristone
• Placebo misoprostol
Matching placebo pills of 800mcg misoprostol

Locations

Country	Name	City	State
United States	Planned Parenthood of Mid and South Michigan	Ann Arbor	Michigan
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts
United States	Montefiore Family Health Center	Bronx	New York
United States	Family Planning Associates Medical Group, Ltd.	Chicago	Illinois
United States	Planned Parenthood of Illinois	Chicago	Illinois
United States	Planned Parenthood of Northern California	Concord	California
United States	Planned Parenthood of the Rocky Mountains	Denver	Colorado
United States	Planned Parenthood of the Heartland	Des Moines	Iowa
United States	Emma Goldman Clinic	Iowa City	Iowa
United States	Planned Parenthood of Central and Greater Northern New Jersey	Morristown	New Jersey
United States	Planned Parenthood of the Pacific Southwest	San Diego	California
United States	Planned Parenthood of Northern New England	Topsham	Maine
United States	Presidential Women's Center	West Palm Beach	Florida
United States	Northland Family Planning Clinic Inc.	Westland	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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