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
  Hide Detailed Description

Detailed Description:

Mifepristone medical abortion has been available in France for a decade and a half and in the United States since 2001. Over this time, it has been demonstrated to be as safe as or safer than either surgical abortion or carrying a pregnancy to term. Furthermore, as medical abortion employs medications rather than surgery to terminate a pregnancy, it has the potential to greatly increase the availability of locations providing abortion services in the US, eliminating as it does the need for expensive equipment and surgical training.

Unfortunately, however, although the availability of medical abortion in the US has increased with time, it has yet to achieve its full potential. In large part this appears to be due to two factors which inhibit providers from offering, and women from choosing, the procedure: 1) Although the approved US medical abortion regimen does not require providers to use ultrasound examination as part of the procedure, it has become common practice for providers to do so. This both increases the cost of the procedure and limits the number of facilities that can offer it. 2) While surgical abortion typically requires only one clinic visit, medical abortion requires (officially) three or (in practice) two visits, making it more expensive, less convenient, and less attractive to women.

There is already a great deal of evidence that medical abortion can be safely offered with two (or even fewer) office visits, and without routine ultrasonography. Most medical abortions in the United States, in fact, currently require only two visits, and the possibility exists that women could self-screen at home, based on a symptom checklist, to determine if the second of these (the follow-up visit) is necessary – an approach that could spare the large majority of medical abortion clients who have uncomplicated courses an extra trip to the clinic. There are, in addition, several less-expensive and less technology-intensive approaches to gathering the diagnostic information currently being provided, pre- and post-procedure, by ultrasonography.

The purpose of the current study is to test the feasibility and efficacy of an approach to medical abortion that forgoes the routine use of ultrasonography. It will also provide evidence on the feasibility of eliminating the requirement for a universal follow-up visit based on self-screening by medical abortion clients. In providing data to make these tests, however, the study protocol will not in any way abridge the medical abortion care currently received by clients at the participating facilities. The study will permit clients to receive standard care (including a follow-up visit and pre- and post-procedure ultrasound examinations in all cases) while gathering valuable information which, we hope, will provide a basis for simplifying standard care in the future.

The research questions to be answered by the study are:

  1. Do an interview with the abortion client, a pregnancy test and a physical exam provide adequate information to determine which abortion clients are eligible for the medical abortion procedure and which should be referred for sonography (or other diagnostic tests) before making such a determination?
  2. Can a self-administered symptom diary and a follow-up low-sensitivity pregnancy test provide an adequate basis to determine whether a woman has undergone a successful medical abortion or whether she requires a sonographic exam (or other diagnostic test) in order to make this determination?
  3. Does a post-abortion pelvic examination provide valuable additional information for determining whether a woman has undergone a successful medical abortion or whether she requires a sonographic exam (or other diagnostic test) in order to make this determination?
  4. Can a self-administered symptom diary and a low-sensitivity pregnancy test provide an adequate basis for determining which medical abortion clients require a follow-up visit?

The research hypotheses are:

  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.
  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 September 18, 2014