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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00994734
First received: October 9, 2009
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Termination of Pregnancy
 Drug: Mifepristone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Proportion of women who select home-use of mifepristone [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
  • Satisfaction with Method [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Enrollment: 615
Study Start Date: May 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: clinic administration of mifepristone
Experimental: home administration of mifepristone Drug: Mifepristone
home administration of mifepristone

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994734

Locations
United States, Georgia
Feminist Women's Health Center
Atlanta, Georgia, United States
United States, New York
Family Health Center, Montefiore Medical Center
Bronx, New York, United States
Institute for Family Health
New York, New York, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Moldova, Republic of
Municipal Clinical Hospital
Chisinau, Moldova, Republic of
Nepal
Kathmandu Medical College
Kathmandu, Nepal
Nepal Medical College Teaching Hospital
Kathmandu, Nepal
Sponsors and Collaborators
Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00994734     History of Changes
Other Study ID Numbers: 1.2.3
Study First Received: October 9, 2009
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
 Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 16, 2013