NCT02398838

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol 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. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.

Conditions

• Abortion, First Trimester

Interventions

Type	Name	Description
DRUG	Home administration of 200 mg mifepristone	Home administration of 200 mg mifepristone.
DRUG	Home or clinic administration of 400 mcg buccal misoprostol	Home or clinic administration of 400 mcg buccal misoprostol

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2015-03-26
• Last updated: 2015-04-06

Locations

4 sites across 1 country: Georgia