Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

Not Applicable

Completed

• Conditions: Abortion, First Trimester
• Interventions: Drug: Home administration of 200 mg mifepristone; Drug: Home or clinic administration of 400 mcg buccal misoprostol

• Registration Number: NCT02398838
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-26
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 622

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home administration of mifepristone	Home administration of 200 mg mifepristone	Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
Clinic administration of mifepristone	Home or clinic administration of 400 mcg buccal misoprostol	Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
Home administration of mifepristone	Home or clinic administration of 400 mcg buccal misoprostol	Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.

Primary Outcome Measures

Name	Time	Method
Proportion of abortions that are complete without surgical intervention (unit: percent)	15 days	Percentage of women with complete abortion without the need of a surgical intervention.

Secondary Outcome Measures

Name	Time	Method
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent)	15 days	Woman's satisfaction with her medical abortion procedure and side effects experienced.

Trial Locations

Locations (4)

Batumi Maternity House; 🇬🇪 Batumi, Ajara, Georgia

Zestafoni Maternity House; 🇬🇪 Zestafoni, Imereti, Georgia

A. Kambarashvili Clinic; 🇬🇪 Telavi, Kakheti, Georgia

Bolnisi Maternity House; 🇬🇪 Bolnisi, Kvemo Kartli, Georgia