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De-Medicalizing Mifepristone Medical Abortion

This study has been completed.
Planned Parenthood Federation of America
David and Lucile Packard Foundation
Information provided by:
Gynuity Health Projects Identifier:
First received: June 30, 2005
Last updated: April 25, 2007
Last verified: April 2007

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.

Medical Abortion

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: De-Medicalizing Mifepristone Medical Abortion

Resource links provided by NLM:

Further study details as provided by Gynuity Health Projects:

Estimated Enrollment: 4410
Study Start Date: May 2005
Study Completion Date: April 2007
  Show Detailed Description


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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier (NCT Number): Identifier: NCT00120224     History of Changes
Other Study ID Numbers: 1.1.2
Study First Received: June 30, 2005
Last Updated: April 25, 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 processed this record on May 25, 2017