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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00994734
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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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.

Condition or disease Intervention/treatment Phase
Termination of Pregnancy Drug: Mifepristone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 615 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
Study Start Date : May 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abortion

Arms and Interventions
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Arm Intervention/treatment
No Intervention: clinic administration of mifepristone
Experimental: home administration of mifepristone Drug: Mifepristone
home administration of mifepristone


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of women who select home-use of mifepristone [ Time Frame: 1-2 weeks ]
  2. Satisfaction with Method [ Time Frame: 1-2 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994734


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00994734    
Other Study ID Numbers: 1.2.3
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
 Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents