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

April 16, 2012 updated by: Gynuity Health Projects
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

615

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Municipal Clinical Hospital
  • Nepal
      • Kathmandu, Nepal
        • Kathmandu Medical College
      • Kathmandu, Nepal
        • Nepal Medical College Teaching Hospital
  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Feminist Women's Health Center
    • New York
      • Bronx, New York, United States
        • Family Health Center, Montefiore Medical Center
      • New York, New York, United States
        • Institute for Family Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: clinic administration of mifepristone
Experimental: home administration of mifepristone
Drug: Mifepristone
home administration of mifepristone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of women who select home-use of mifepristone
Time Frame: 1-2 weeks
1-2 weeks
Satisfaction with Method
Time Frame: 1-2 weeks
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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