Clinical Trials Directory

Trials / Completed

CompletedNCT00386282

Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,250 (actual)
Sponsor
Gynuity Health Projects · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGmifepristone-misoprostol treatment200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.

Timeline

Start date
2006-09-01
Primary completion
2011-03-01
Completion
2011-03-01
First posted
2006-10-11
Last updated
2014-07-30

Locations

11 sites across 4 countries: Armenia, Azerbaijan, Mexico, Puerto Rico

Source: ClinicalTrials.gov record NCT00386282. Inclusion in this directory is not an endorsement.