Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

July 29, 2014 updated by: Gynuity Health Projects

Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation

This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.

Study Type

Interventional

Enrollment (Actual)

1250

Phase

  • Not Applicable

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

  • Armenia
      • Yerevan, Armenia
        • Center for Family Planning and Sexual Health
      • Yerevan, Armenia
        • Institute of Perinatology, Obstetrics and Gynecology
      • Yerevan, Armenia
        • State Medical University
  • Azerbaijan
      • Baku, Azerbaijan
        • Family planning center
      • Baku, Azerbaijan
        • Scientific Research Institute of Obstetrics and Gynecology
  • Mexico
    • Federal District
      • Mexico City, Federal District, Mexico
        • C.S. Beatriz Velasco Aleman
      • Mexico City, Federal District, Mexico
        • C.S. Santa Catarina
      • Mexico City, Federal District, Mexico
        • H.G. Enrique Cabrera
      • Mexico City, Federal District, Mexico
        • H.M.I Inguaran
  • Puerto Rico
      • Lomas Verdes, Bayamon, Puerto Rico, 00956
        • Clinica de Planificacion Familiar
      • San Juan, Puerto Rico, 00921
        • Woman's Metropolitan Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestation up to 63 days
  • General good health
  • Willingness to provide contact information for follow-up
  • Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

Exclusion Criteria:

  • Ectopic pregnancy
  • Intrauterine device (IUD) in place

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: mifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone
Drug: mifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.
Other Names:
  • medical abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
efficacy
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
acceptability
Time Frame: 15 days
15 days

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Investigators

  • Principal Investigator: Hector Diaz Martinez, MD, Clinica de Planificacion Familiar
  • Principal Investigator: Angela Arredondo, MD, Woman's Metropolitan Center
  • Principal Investigator: Gulnara Rzaeva, MD, Scientific Research Institute of Obstetrics & Gynecology
  • Principal Investigator: Besti Muradova, MD, Family planning center
  • Principal Investigator: Susanna Fildjyan, MD, Institute of Perinatology, Obstetrics and Gynecology
  • Principal Investigator: Armine Harutyunyan, MD, Center for Family Planning and Sexual Health
  • Principal Investigator: Anna Aghajanyan, MD, State Medical University
  • Principal Investigator: Ranulfo Rios, MD, H G Enrique Cabrera
  • Principal Investigator: Laura Garcia Martinez, MD, H.M.I Inguaran
  • Principal Investigator: Antonio E Flores, MD, C S Beatriz Velasco Aleman
  • Principal Investigator: Elba Margarita Lugo Hernandez, MD, C S Santa Catarina

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

September 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 9, 2006

First Submitted That Met QC Criteria

October 9, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.1.4

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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