Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation
Overview
- Phase
- Not Applicable
- Intervention
- mifepristone-misoprostol treatment
- Conditions
- Abortion, First Trimester
- Sponsor
- Gynuity Health Projects
- Enrollment
- 1250
- Locations
- 11
- Primary Endpoint
- efficacy
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.
Detailed Description
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gestation up to 63 days
- •General good health
- •Willingness to provide contact information for follow-up
- •Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination
Exclusion Criteria
- •Ectopic pregnancy
- •Intrauterine device (IUD) in place
Arms & Interventions
mifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone
Intervention: mifepristone-misoprostol treatment
Outcomes
Primary Outcomes
efficacy
Time Frame: 15 days
Secondary Outcomes
- acceptability(15 days)