De-Medicalizing Mifepristone Medical Abortion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00120224|
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : April 27, 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:
- 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.
- 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.
- 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 or disease|
|Study Type :||Observational|
|Enrollment :||4410 participants|
|Observational Model:||Defined Population|
|Official Title:||De-Medicalizing Mifepristone Medical Abortion|
|Study Start Date :||May 2005|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Principal Investigator:||Wesley Clark, MPH||Gynuity Health Projects|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|