Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

February 18, 2014 updated by: Gynuity Health Projects

A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

The goal of this study is to provide answers to the following four questions:

  1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
  2. Are the side effects with sublingual use tolerable for women?
  3. Is sublingual administration of misoprostol acceptable to women?
  4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1443

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

  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • State University of Medicine and Pharmacy
  • Tunisia
      • Ariana, Tunisia
        • Centre de Planification Familiale de l'Ariana
      • Tunis, Tunisia
        • Maternité de La Rabta
      • Tunis, Tunisia
        • Centre de Planification Familiale la Bardo
      • Tunis, Tunisia
        • Private Clinic
  • Turkey
      • Ankara, Turkey
        • Dr. Zekai Tahir Burak Women's Health Training and Research Hospital
      • Ankara, Turkey
        • MoH Ankara Etlik Maternity and Gyneacological Training Hospital
      • Istanbul, Turkey
        • Haydarpaşa Numune Training and Research Hospital Family Planning Clinic
      • Izmir, Turkey
        • Ege Maternity and Gyneacological Training and Research Hospital

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

Description

Inclusion Criteria:

  • Women presenting for medical abortion who consent to participate
  • Possibility of final gestational age of less than or equal to 63 days
  • General good health
  • Willing to provide contact information for purposes of follow-up

Exclusion Criteria:

  • Conditions which contraindicate the use of mifepristone or misoprostol
  • Women presenting for medical abortion who do not consent to participate

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sublingual Misoprostol
400 mcg of sublingual misoprostol
Drug: Mifepristone, misoprostol
Active Comparator: Oral Misoprostol
Misoprostol administered orally
Drug: Mifepristone, misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Time Frame: 2 weeks after mifepristone administration
2 weeks after mifepristone administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: 48 hours
48 hours
Acceptability for women
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Investigators

  • Study Director: Sheila Raghavan, M.Sc., Gynuity Health Projects
  • Principal Investigator: Selma Hajri, MD, Reproductive Health Consultant
  • Principal Investigator: Ayse Akin, MD, MPH, Baskent University

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, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria

February 1, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.1.5

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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