Clinical trial NCT01966874: Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation
Official title: Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical; Abortion, Fetus
Keywords: Medical abortion
Mifepristone
Misoprostol
Zacafemyl
Mexico
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Secretaria de Salud, Mexico
First posted: 2013-10-22
Enrollment: 1001
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at the study clinics who want medical abortion and meet eligibility criteria.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy
timeFrame: One week after enrollment
Secondary outcomes:
measure: Acceptability
timeFrame: One week after enrollment
Other outcomes:
Locations:
city: New York
country: United States
facility: Gynuity Health Projects
state: New York
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Secretaria de Salud, Mexico
name: Patricio Sanhueza Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: M.I. Inguaran
name: Maria Laura Garcia
role: PRINCIPAL_INVESTIGATOR
affiliation: C.S. Beatriz Velasco
name: Ana Gabriela Arangure Peraza
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grupo de Informacion en Reproduccion Elegida (GIRE). El aborto en los codigos penales de las entidades federativas. Citacion obtenida por Internet el 8 de octubre de 2007. http://www.gire.org.mx/contenido.php?informacion=31
citation: Bracken H, Ngoc NT, Schaff E, Coyaji K, Ambardekar S, Westheimer E, Winikoff B. Mifepristone followed in 24 hours to 48 hours by misoprostol for late first-trimester abortion. Obstet Gynecol. 2007 Apr;109(4):895-901. doi: 10.1097/01.AOG.0000259319.18958.76.
citation: Ashok PW, Hamoda H, Flett GM, Kidd A, Fitzmaurice A, Templeton A. Patient preference in a randomized study comparing medical and surgical abortion at 10-13 weeks gestation. Contraception. 2005 Feb;71(2):143-8. doi: 10.1016/j.contraception.2004.08.013.
citation: Ashok PW, Kidd A, Flett GM, Fitzmaurice A, Graham W, Templeton A. A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation. Hum Reprod. 2002 Jan;17(1):92-8. doi: 10.1093/humrep/17.1.92.
citation: Gouk EV, Lincoln K, Khair A, Haslock J, Knight J, Cruickshank DJ. Medical termination of pregnancy at 63 to 83 days gestation. Br J Obstet Gynaecol. 1999 Jun;106(6):535-9. doi: 10.1111/j.1471-0528.1999.tb08320.x.
citation: Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005 Aug;112(8):1102-8. doi: 10.1111/j.1471-0528.2005.00638.x.
citation: Hamoda H, Ashok PW, Flett GM, Templeton A. A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation. Hum Reprod. 2005 Aug;20(8):2348-54. doi: 10.1093/humrep/dei037. Epub 2005 May 5.
citation: Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks' gestation: a review of 1076 consecutive cases. Contraception. 2005 May;71(5):327-32. doi: 10.1016/j.contraception.2004.10.015.
citation: Datos no publicados. Comunicacion personal I. Dzuba, Gynuity Health Projects, 22 de junio del 2011.
citation: Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.