De-Medicalizing Mifepristone Medical Abortion

This study has been completed.
Sponsor:
Collaborators:
Planned Parenthood Federation of America
David and Lucile Packard Foundation
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00120224
First received: June 30, 2005
Last updated: April 25, 2007
Last verified: April 2007
  Purpose

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
Medical Abortion

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00120224

Locations
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
Investigators
Principal Investigator: Wesley Clark, MPH Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: June 30, 2005
Last Updated: April 25, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Gynuity Health Projects:
Mifepristone
Medical abortion
Ultrasound

Additional relevant MeSH terms:
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 28, 2014