Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

Gynuity Health Projects

Status: Completed

Conditions: Abortion, First Trimester

Treatments: Drug: Home administration of 200 mg mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT02219100

1.2.3.1

Details and patient eligibility

About

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.

Enrollment: 613 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• 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
• Eligible for medical abortion according to the clinician's assessment
• 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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613 participants in 2 patient groups

Home administration of mifepristone

Experimental group

Description:

This arm consisted of women who chose home administration of 200 mg mifepristone.

Treatment:

Drug: Home administration of 200 mg mifepristone

Clinic administration of mifepristone

No Intervention group

Description:

This arm consisted of women who underwent clinic administration of 200 mg mifepristone.