Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

Gynuity Health Projects

Status: Completed

Conditions: Abortion, First Trimester

Treatments: Drug: Home or clinic administration of 400 mcg buccal misoprostol; Drug: Home administration of 200 mg mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT02398838

1.2.4.5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 622 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old
• In good general health
• Living or working close to the study site
• Intrauterine pregnancy less than 64 days gestation
• Willing and able to sign consent forms
• Ready access to a telephone and emergency transportation
• Willing to provide an address and/or telephone number for purposes of follow-up
• Agree to comply with the study procedures and visit schedule

Exclusion criteria

• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
• IUD in place (IUD must be removed first)
• Chronic renal failure
• Concurrent long-term corticosteroid therapy
• History of allergy to mifepristone, misoprostol or other prostaglandin
• Hemorrhagic disorders or concurrent anticoagulant therapy
• Inherited porphyrias
• Other serious physical or mental health conditions

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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622 participants in 2 patient groups

Home administration of mifepristone

Experimental group

Description:

Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.

Treatment:

Drug: Home administration of 200 mg mifepristone

Drug: Home or clinic administration of 400 mcg buccal misoprostol

Clinic administration of mifepristone

Active Comparator group

Description:

Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.

Treatment:

Drug: Home or clinic administration of 400 mcg buccal misoprostol