Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

Gynuity Health Projects

Status: Completed

Conditions: Abortion, First Trimester

Treatments: Drug: mifepristone-misoprostol treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00386282

1.1.4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,250 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,250 participants in 1 patient group

mifepristone-misoprostol treatment

Other group

Description:

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone

Treatment:

Drug: mifepristone-misoprostol treatment