Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and acceptability of a regimen of 200 mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.

Detailed Description
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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.

Official Title
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Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation

Conditions
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Medical; Abortion, Fetus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of reproductive age Gestational age less than or equal to 70 days LMP Willing and capable of accepting and participating Eligible for medical abortion according to the clinic's evaluation Willing to undergo a surgical intervention to complete the abortion if necessary Willing to provide an address and/or telephone number for follow up Have easy, straightforward access to a telephone and emergency transport Exclusion Criteria: Gestational age is greater than 70 days LMP Suspicion or diagnosis of ectopic pregnancy or undiagnosed adnexal mass Use of IUD (note: the woman will be eligible when she removes the IUD) Chronic renal failure Current long term treatment with corticosteroids Allergy to mifepristone, misoprostol, or other prostaglandin Coagulopathies or current treatment with anti-coagulants Hereditary porphyrias
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>All study participants will receive 200 mg of the mifepristone product Zacafemyl, followed 24-48 hours later by 800 mcg of misoprostol. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Was the method effective in terminating pregnancy? This will be determined by the need for surgical intervention and the dose of misoprostol required. | One week after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | 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. | One week after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical abortion, Mifepristone, Misoprostol, Zacafemyl, Mexico