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

NCT01966874 | Completed DMC

• 1 other identifier: 1002
• Study Type: observational
• Target: 1,001
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical; Abortion, Fetus

Keywords

Medical abortion; Mifepristone; Misoprostol; Zacafemyl; Mexico

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability

  One week after enrollment

Study Arms (1)

Study population

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at the study clinics who want medical abortion and meet eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Secretaria de Salud, Mexico: collaborator

Study Sites (1)

Gynuity Health Projects

New York, New York, 10010, United States

Location

Related Publications (10)

• 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

  BACKGROUND

• 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.

  PMID: 17400851 BACKGROUND

• 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.

  PMID: 15707565 BACKGROUND

• 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.

  PMID: 11756368 BACKGROUND

• 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.

  PMID: 10426609 BACKGROUND

• 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.

  PMID: 16045525 BACKGROUND

• 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.

  PMID: 15878927 BACKGROUND

• 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.

  PMID: 15854631 BACKGROUND

• Datos no publicados. Comunicacion personal I. Dzuba, Gynuity Health Projects, 22 de junio del 2011.

  BACKGROUND

• 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.

  PMID: 19037040 BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 22, 2013
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

US (1)