Clinical trial NCT02704481: Non-surgical Alternatives to Treatment of Failed Medical Abortion
Official title: Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Abortion Failure
Keywords: mifepristone
misoprostol
medical abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: One week after taking first study medication
Secondary outcomes:
measure: The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
timeFrame: One week after taking first study medication
measure: The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
timeFrame: One week after taking first study medication
Other outcomes:
Locations:
city: Concord
country: United States
facility: Planned Parenthood of Northern California
state: California
city: San Diego
country: United States
facility: Planned Parenthood of the Pacific Southwest
state: California
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: West Palm Beach
country: United States
facility: Presidential Women's Center
state: Florida
city: Chicago
country: United States
facility: Planned Parenthood of Illinois
state: Illinois
city: Chicago
country: United States
facility: Family Planning Associates Medical Group, Ltd.
state: Illinois
city: Des Moines
country: United States
facility: Planned Parenthood of the Heartland
state: Iowa
city: Iowa City
country: United States
facility: Emma Goldman Clinic
state: Iowa
city: Topsham
country: United States
facility: Planned Parenthood of Northern New England
state: Maine
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: Planned Parenthood of Mid and South Michigan
state: Michigan
city: Westland
country: United States
facility: Northland Family Planning Clinic Inc.
state: Michigan
city: Morristown
country: United States
facility: Planned Parenthood of Central and Greater Northern New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Family Health Center
state: New York
Study officials:
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Tara Shochet, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: