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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02704481
Other study ID # 1035
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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