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

Not Applicable

Completed

• Conditions: Abortion, First Trimester
• Interventions: Drug: Home administration of 200 mg mifepristone

• Registration Number: NCT02219100
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2014-07-29
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 613

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home administration of mifepristone	Home administration of 200 mg mifepristone	This arm consisted of women who chose home administration of 200 mg mifepristone.

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 (5)

Gyumri Maternity Hospital; 🇦🇲 Gyumri, Armenia

Vanadzor Hospital #1; 🇦🇲 Vanadzor, Armenia

Antenatal Clinic; 🇦🇿 Gandja, Azerbaijan

Family Planning Center; 🇦🇿 Gandja, Azerbaijan

Gynecology Department of the Central Regional Hospital; 🇦🇿 Zaqatala, Azerbaijan