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De-Medicalizing Mifepristone Medical Abortion

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ClinicalTrials.gov Identifier: NCT00120224
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : April 27, 2007
Information provided by:

Study Description
Brief Summary:

This study will investigate the possibility that medical abortion using mifepristone and misoprostol - a safe, proven therapy for terminating early first trimester pregnancy - can be administered in a manner that is simpler and less costly than that routinely employed in the United States.

The researchers hypothesize that:

  1. Practitioners themselves, based on history and examination but without sonography, are able to dependably and correctly determine which patients are eligible for medical abortion and which patients either are not eligible or require further evaluation to determine eligibility.
  2. Practitioners themselves, based on a symptom diary and low-sensitivity pregnancy test but without sonography, are able to dependably and correctly determine when a successful medical abortion has taken place and when referral for other possible outcomes should be made.
  3. A symptom diary and low-sensitivity pregnancy test are safe and effective means of separating those women who could benefit from a follow-up visit from those who do not need one.

Condition or disease
Medical Abortion

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 4410 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: De-Medicalizing Mifepristone Medical Abortion
Study Start Date : May 2005
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women presenting at study clinics for medical abortion who agree to complete home study card and return for follow-up visit

Exclusion Criteria:

  • Women presenting at study clinics for medical abortion who do not agree to participate in study.
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): NCT00120224

United States, California
Planned Parenthood of San Diego and Riverside Counties
San Diego, California, United States, 92108
United States, Illinois
Family Planning Associates Medical Group
Chicago, Illinois, United States, 60630
United States, New York
Planned Parenthood of New York City
New York City, New York, United States, 10012
Sponsors and Collaborators
Gynuity Health Projects
Planned Parenthood Federation of America
David and Lucile Packard Foundation
Principal Investigator: Wesley Clark, MPH Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120224     History of Changes
Other Study ID Numbers: 1.1.2
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Gynuity Health Projects:
Medical abortion

Additional relevant MeSH terms:
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