De-Medicalizing Mifepristone Medical Abortion
|First Received Date ICMJE||June 30, 2005|
|Last Updated Date||April 25, 2007|
|Start Date ICMJE||May 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00120224 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||De-Medicalizing Mifepristone Medical Abortion|
|Official Title ICMJE||De-Medicalizing Mifepristone Medical Abortion|
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:
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:
The research hypotheses are:
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Medical Abortion|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00120224|
|Other Study ID Numbers ICMJE||1.1.2|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Gynuity Health Projects|
|Information Provided By||Gynuity Health Projects|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP