Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
1 other identifier
interventional
615
3 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedApril 17, 2012
April 1, 2012
1.8 years
October 9, 2009
April 16, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of women who select home-use of mifepristone
1-2 weeks
Satisfaction with Method
1-2 weeks
Study Arms (2)
clinic administration of mifepristone
NO INTERVENTIONhome administration of mifepristone
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Feminist Women's Health Center
Atlanta, Georgia, United States
Institute for Family Health
New York, New York, United States
Family Health Center, Montefiore Medical Center
The Bronx, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Municipal Clinical Hospital
Chisinau, Moldova
Kathmandu Medical College
Kathmandu, Nepal
Nepal Medical College Teaching Hospital
Kathmandu, Nepal
Related Publications (1)
Conkling K, Karki C, Tuladhar H, Bracken H, Winikoff B. A prospective open-label study of home use of mifepristone for medical abortion in Nepal. Int J Gynaecol Obstet. 2015 Mar;128(3):220-3. doi: 10.1016/j.ijgo.2014.09.022. Epub 2014 Nov 27.
PMID: 25482435DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 14, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 17, 2012
Record last verified: 2012-04