Completed

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

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What is being tested

Mifepristone and misoprostol

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Phase 4
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorGynuity Health Projects
Last updated: December 10, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorGynuity Health Projects
Last updated: December 10, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

1738 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Aminbazar Rural Dispensary

Aminbazar, BangladeshOpen Aminbazar Rural Dispensary in Google Maps

MCH-Unit, Upazilla Health Center

Savar Upazila, Bangladesh

Tetulzhora UH&FWC

Tetuljhora, Bangladesh

Chartarapur UH & FWC

Chandrapur, Bangladesh
Completed8 Study Centers