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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994734
First Posted: October 14, 2009
Last Update Posted: April 17, 2012
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.
Information provided by (Responsible Party):
Gynuity Health Projects
  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: None (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:


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 ]
  • Satisfaction with Method [ Time Frame: 1-2 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00994734     History of Changes
Other Study ID Numbers: 1.2.3
First Submitted: October 9, 2009
First Posted: October 14, 2009
Last Update Posted: April 17, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
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
Menstruation-Inducing Agents


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