Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

Not Applicable

Completed

• Conditions: Abortion, First Trimester
• Interventions: Drug: mifepristone-misoprostol treatment

• Registration Number: NCT00386282
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-09
• Study First Submitted QC: 2006-10-09
• Study First Posted: 2006-10-11
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mifepristone-misoprostol treatment	mifepristone-misoprostol treatment	200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone

Primary Outcome Measures

Name	Time	Method
efficacy	15 days

Secondary Outcome Measures

Name	Time	Method
acceptability	15 days

Trial Locations

Locations (11)

State Medical University; 🇦🇲 Yerevan, Armenia

Family Planning Center; 🇦🇿 Baku, Azerbaijan

Scientific Research Institute of Obstetrics and Gynecology; 🇦🇿 Baku, Azerbaijan

C.S. Santa Catarina; 🇲🇽 Mexico City, Federal District, Mexico

H.G. Enrique Cabrera; 🇲🇽 Mexico City, Federal District, Mexico

Center for Family Planning and Sexual Health; 🇦🇲 Yerevan, Armenia

Institute of Perinatology, Obstetrics and Gynecology; 🇦🇲 Yerevan, Armenia

C.S. Beatriz Velasco Aleman; 🇲🇽 Mexico City, Federal District, Mexico

H.M.I Inguaran; 🇲🇽 Mexico City, Federal District, Mexico

Clinica de Planificacion Familiar; 🇵🇷 Lomas Verdes, Bayamon, Puerto Rico

Woman's Metropolitan Center; 🇵🇷 San Juan, Puerto Rico