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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
Sponsor:
Collaborator:
Secretaria de Salud, Mexico
Information provided by (Responsible Party):
Gynuity Health Projects

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.

Condition or disease
Medical; Abortion, Fetus

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.


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Study Type : Observational
Actual Enrollment : 1001 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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".



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women at the study clinics who want medical abortion and meet eligibility criteria.
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

Information from the National Library of Medicine

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


Locations
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United States, New York
Gynuity Health Projects
New York, New York, United States, 10010
Sponsors and Collaborators
Gynuity Health Projects
Secretaria de Salud, Mexico
Investigators
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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

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

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01966874     History of Changes
Other Study ID Numbers: 1002
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by Gynuity Health Projects:
Medical abortion
Mifepristone
Misoprostol
Zacafemyl
Mexico

Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents