Non-surgical Alternatives to Treatment of Failed Medical Abortion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mifepristone-misoprostol 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
200mg oral mifepristone
Other Names:
Drug: Misoprostol
800mcg buccal misoprostol
Other Names:
Drug: Placebo misoprostol
Matching placebo pills of 800mcg misoprostol
|
| Experimental: Misoprostol-misoprostol 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
800mcg buccal misoprostol
Other Names:
Drug: Placebo mifepristone
Matching placebo pill of 200mg mifepristone
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Planned Parenthood of Northern California | Concord | California | United States | 94520 |
| 2 | Planned Parenthood of the Pacific Southwest | San Diego | California | United States | 92108 |
| 3 | Planned Parenthood of the Rocky Mountains | Denver | Colorado | United States | 80207 |
| 4 | Presidential Women's Center | West Palm Beach | Florida | United States | 33407 |
| 5 | Planned Parenthood of Illinois | Chicago | Illinois | United States | 60603 |
| 6 | Family Planning Associates Medical Group, Ltd. | Chicago | Illinois | United States | 60661 |
| 7 | Planned Parenthood of the Heartland | Des Moines | Iowa | United States | 50305 |
| 8 | Emma Goldman Clinic | Iowa City | Iowa | United States | 52245 |
| 9 | Planned Parenthood of Northern New England | Topsham | Maine | United States | 04086 |
| 10 | Planned Parenthood League of Massachusetts | Boston | Massachusetts | United States | 02215 |
| 11 | Planned Parenthood of Mid and South Michigan | Ann Arbor | Michigan | United States | 48108 |
| 12 | Northland Family Planning Clinic Inc. | Westland | Michigan | United States | 48185 |
| 13 | Planned Parenthood of Central and Greater Northern New Jersey | Morristown | New Jersey | United States | 07960 |
| 14 | Montefiore Family Health Center | Bronx | New York | United States | 10458 |
Sponsors and Collaborators
- Gynuity Health Projects
Investigators
- Principal Investigator: Ilana Dzuba, MHS, Gynuity Health Projects
- Principal Investigator: Tara Shochet, PhD, MPH, Gynuity Health Projects
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1035