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De-Medicalizing Mifepristone Medical Abortion

This study has been completed.

Sponsors and Collaborators: Gynuity Health Projects
Planned Parenthood Federation of America
David and Lucile Packard Foundation
Information provided by: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00120224
  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

MedlinePlus related topics:   Abortion    Pregnancy Loss    Ultrasound   

Drug Information available for:   Mifepristone   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Prospective Study
Official Title:   De-Medicalizing Mifepristone Medical Abortion

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  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

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


Related Info  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   1.1.2
First Received:   June 30, 2005
Last Updated:   April 25, 2007
ClinicalTrials.gov Identifier:   NCT00120224
Health Authority:   United States: Institutional Review Board

Keywords provided by Gynuity Health Projects:
Mifepristone  
Medical abortion  
Ultrasound  

Study placed in the following topic categories:
Pregnancy Complications
Mifepristone
Abortion, Spontaneous

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on October 28, 2008




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