NCT01410266

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

The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,400 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Medical Abortion, Fetus

Interventions

Type	Name	Description
OTHER	Alternative follow-up	Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-08-05
• Last updated: 2012-12-03

Locations

7 sites across 2 countries: Moldova, Uzbekistan