Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

Not Applicable

Completed

• Conditions: Termination of Pregnancy
• Interventions: Drug: Mifepristone

• Registration Number: NCT00994734
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 615

Inclusion Criteria

• Reproductive age women seeking abortion services.
• Eligible women will be in general good health and assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken.
• Participants must be eligible for medical abortion according to clinician and clinic standards.
• In the United States, women only 18 years and older will be eligible to participate, unless the study site obtains a waiver to include minors.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
home administration of mifepristone	Mifepristone	-

Primary Outcome Measures

Name	Time	Method
Proportion of women who select home-use of mifepristone	1-2 weeks
Satisfaction with Method	1-2 weeks

Trial Locations

Locations (7)

Feminist Women's Health Center; 🇺🇸 Atlanta, Georgia, United States

Family Health Center, Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Institute for Family Health; 🇺🇸 New York, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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

Kathmandu Medical College; 🇳🇵 Kathmandu, Nepal

Nepal Medical College Teaching Hospital; 🇳🇵 Kathmandu, Nepal