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

Termination of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994734
• Other study ID #: 1.2.3
• Status: Completed
• Phase: N/A
• First received: October 9, 2009
• Last updated: April 16, 2012
• Start date: May 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Termination of Pregnancy

Intervention

Drug:
• Mifepristone
home administration of mifepristone

Locations

Country	Name	City	State
Moldova, Republic of	Municipal Clinical Hospital	Chisinau
Nepal	Kathmandu Medical College	Kathmandu
Nepal	Nepal Medical College Teaching Hospital	Kathmandu
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

United States,  Moldova, Republic of,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who select home-use of mifepristone		1-2 weeks
Primary	Satisfaction with Method		1-2 weeks