Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan

Phase 4

Completed

• Conditions: Medical Abortion, Fetus

• Registration Number: NCT01410266
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.

Detailed Description

Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.

This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2400

Inclusion Criteria

• Reproductive-age woman seeking a medical abortion
• Woman in good general health
• Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
• Woman able and willing to sign consent forms
• Woman eligible for medical abortion according to clinician's assessment
• Woman agreeing to be followed up with, by phone or at a clinic visit

Exclusion Criteria

• Woman with a pregnancy greater than 63 days gestation on the day of mifepristone administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Continued, ongoing pregnancy	1 month

Secondary Outcome Measures

Name	Time	Method
Percentage of women who return for follow-up	1 month
Percentage of women receiving other treatment for ongoing pregnancy	1 month

Trial Locations

Locations (7)

The Perinatalogy Center; 🇲🇩 Balti, Moldova, Republic of

Municipal Clinical Hospital; 🇲🇩 Chisinau, Moldova, Republic of

The National Center of Reproductive Health and Medical Genetics; 🇲🇩 Chisinau, Moldova, Republic of

The Center of Women Health "Ana"; 🇲🇩 Drochia, Moldova, Republic of

Clinic #2 of Tashkent Medical Academy; 🇺🇿 Tashkent, Uzbekistan

Municipal Maternity House #10; 🇺🇿 Tashkent, Uzbekistan

Women's Wellness Center; 🇺🇿 Tashkent, Uzbekistan