Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

NCT ID: NCT02398838

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 622 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Home administration of mifepristone

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

Group Type: EXPERIMENTAL

Home administration of 200 mg mifepristone

Intervention Type: DRUG

Home administration of 200 mg mifepristone.

Home or clinic administration of 400 mcg buccal misoprostol

Intervention Type: DRUG

Home or clinic administration of 400 mcg buccal misoprostol

Clinic administration of mifepristone

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

Group Type: ACTIVE_COMPARATOR

Home or clinic administration of 400 mcg buccal misoprostol

Intervention Type: DRUG

Home or clinic administration of 400 mcg buccal misoprostol

Interventions

Home administration of 200 mg mifepristone

Home administration of 200 mg mifepristone.

Intervention Type: DRUG

Home or clinic administration of 400 mcg buccal misoprostol

Home or clinic administration of 400 mcg buccal misoprostol

Intervention Type: DRUG

Other Intervention Names

Penkrofton

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

Batumi Maternity House

Batumi, Adjara, Georgia

Zestafoni Maternity House

Zestaponi, Imereti, Georgia

A. Kambarashvili Clinic

Telavi, Kakheti, Georgia

Bolnisi Maternity House

Bolnisi, Kvemo Kartli, Georgia

Countries

Georgia

Other Identifiers

1.2.4.5

Identifier Type: -

Identifier Source: org_study_id