Abortion Failure Clinical Trial
Official title:
Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial
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 |
Verified date | July 2021 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
United States,
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 |