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

Gynuity Health Projects

Status: Completed

Conditions: Medical; Abortion, Fetus

Study type: Observational

Funder types: Other

Identifiers

NCT01966874

1002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,001 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,001 participants in 1 patient group

Study population

Description:

All study participants will receive 200 mg of the mifepristone product "Zacafemyl", followed 24-48 hours later by 800 mcg of misoprostol.