Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation
|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: NCT01966874|
Recruitment Status : Completed
First Posted : October 22, 2013
Last Update Posted : October 22, 2013
|Condition or disease|
|Medical; Abortion, Fetus|
In Mexico City, the registration of a new mifepristone product signals a new wave in the SSDF's program for terminating pregnancies up to 70 days. This study evaluates the efficacy of the product Zacafemyl for the termination of pregnancy up to 70 days LMP. It also evaluates the incidence and acceptability of side effects of the medication and regimen. Participants are women of reproductive age with a gestational age of less than or equal to 70 days who want and are eligible for medical abortion, are willing and able to provide all follow up information, and have no contraindications.
Women who are eligible and consent to enroll in the study will be given 200 mg of mifepristone orally in the clinic. The participants will then be given 800 mcg of misoprostol (four 200 mcg tablets) to take home and instructed to take two tablets bucally 24-48 hours after the mifepristone and the remaining tablets within 30 minutes. They will be warned of the side effects they may experience.
All participants will be informed that they can call the clinic in case they have questions about the symptoms or side effects or if they have other concerns. They will also be told that they can return to the clinic in case of severe or persistent bleeding, or if they decide at any point that they want surgical intervention. Participants will also be informed as to the signs of pregnancy termination.
Seven days after taking the mifepristone (the eighth day of the study) the woman should return to the clinic for follow up. Information will be collected on a series of six semi-structured forms that are filled out by members of the study team in accordance with the responses of the participants to the interview questions and the results of physical exams, ultrasounds, etc. Analyses of the data will focus on efficacy, acceptability, side effects, and adverse events.
|Study Type :||Observational|
|Actual Enrollment :||1001 participants|
|Official Title:||Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
All study participants will receive 200 mg of the mifepristone product "Zacafemyl", followed 24-48 hours later by 800 mcg of misoprostol.
- Efficacy [ Time Frame: One week after enrollment ]Was the method effective in terminating pregnancy? This will be determined by the need for surgical intervention and the dose of misoprostol required.
- Acceptability [ Time Frame: One week after enrollment ]Was the method acceptable from the perspective of the woman? Were the side effects acceptable to women? Was the buccal route acceptable to women? Responses will be marked as "very satisfied", "satisfied", "neither satisfied nor unsatisfied", "unsatisfied", or "very unsatisfied".
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): NCT01966874
|United States, New York|
|Gynuity Health Projects|
|New York, New York, United States, 10010|
|Principal Investigator:||Beverly Winikoff, MD||Gynuity Health Projects|
|Principal Investigator:||Patricio Sanhueza Smith||Secretaria de Salud, Mexico|
|Principal Investigator:||Maria Laura Garcia||M.I. Inguaran|
|Principal Investigator:||Ana Gabriela Arangure Peraza||C.S. Beatriz Velasco|