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

October 17, 2013 updated by: Gynuity Health Projects
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Gynuity Health Projects

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
One week after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Secretaria de Salud, Mexico

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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