Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh

December 8, 2015 updated by: Gynuity Health Projects
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.

The specific aims of this project are as follows:

  • Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh;
  • Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and
  • Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.

Study Type

Interventional

Enrollment (Actual)

1738

Phase

  • Phase 4

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

  • Bangladesh
      • Dhaka, Bangladesh
        • Mohammadpur Fertility Services and Training Center
    • Dhaka
      • Savar, Dhaka, Bangladesh
        • MCH-Unit, Upazilla Health Center
    • Dhaka Division
      • Aminbazar, Dhaka Division, Bangladesh
        • Aminbazar Rural Dispensary
      • Tetuljhora, Dhaka Division, Bangladesh
        • Tetulzhora UH&FWC
    • Rajshahi
      • Chandrapur, Rajshahi, Bangladesh
        • Chartarapur UH & FWC
      • Goyespur, Rajshahi, Bangladesh
        • Goyeshpur UH &FWC
      • Pabna, Rajshahi, Bangladesh
        • MCH Unit, Sadar Upazilla
      • Pabna, Rajshahi, Bangladesh
        • Pabna MCWC

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:

  • Be willing and able to sign consent forms;
  • Be eligible for menstrual regulation (MR) services according to clinician's assessment;
  • Be willing to undergo a surgical evacuation if necessary;
  • Be willing to provide a urine sample prior to administration of the mifepristone
  • Have ready and easy access to a telephone and
  • Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

  • • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;

    • Chronic renal failure;
    • Concurrent long-term corticosteroid therapy;
    • History of allergy to mifepristone, misoprostol or other prostaglandin;
    • Hemorrhagic disorders or concurrent anticoagulant therapy;
    • Inherited porphyrias; or
    • Other serious physical or mental health conditions.

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone-misoprostol
Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol
Drug: Mifepristone and misoprostol
Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
successful menstrual regulation without the need for a surgical evacuation
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Investigators

  • Principal Investigator: Hillary J Bracken, PhD, Gynuity Health Projects
  • Principal Investigator: Laura Reichenbach, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh

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

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004

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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