Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

October 9, 2009 updated by: Gynuity Health Projects
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

  1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
  2. Are the side effects with buccal use tolerable for women?
  3. Is buccal administration of misoprostol acceptable to women?
  4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Study Type

Interventional

Enrollment (Anticipated)

1220

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

  • Georgia
      • Tbilisi, Georgia
        • Maternity House #2
      • Tbilisi, Georgia
        • Maternity House #4
      • Tbilisi, Georgia
        • Zhordania Institute of Human Reproduction
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Hocmon 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18 years or over presenting for abortion services who consent to participate
  • good general health
  • assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
  • Have ready access to a telephone and emergency transportation;
  • Be willing to provide an address and/or telephone number 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
200mg mifepristone followed by 400mcg misoprostol
Drug: Mifepristone, misoprostol
200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
Active Comparator: 2
200mg mifepristone followed by 800mcg misoprostol
Drug: mifepristone, misoprostol
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).
Time Frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit
Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Side-effects, acceptability for women
Time Frame: side effects and acceptability recorded at exit interview
side effects and acceptability recorded at exit interview

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Investigators

  • Study Director: Erica Chong, MPH, Gynuity Health Projects
  • Study Director: Tamuna Tsereteli, MD, MSc, PhD, Gynuity Health Projects

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.

Helpful Links

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

May 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 12, 2009

Last Update Submitted That Met QC Criteria

October 9, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.1.6

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.

Subscribe