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

Phase 4

Completed

• Conditions: Menstrual Regulation
• Interventions: Drug: Mifepristone and misoprostol

• Registration Number: NCT01798017
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Status Verified: 2013-03
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1738

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mifepristone-misoprostol	Mifepristone and misoprostol	Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol

Primary Outcome Measures

Name	Time	Method
successful menstrual regulation without the need for a surgical evacuation	14 days

Trial Locations

Locations (8)

Aminbazar Rural Dispensary; 🇧🇩 Aminbazar, Dhaka Division, Bangladesh

Tetulzhora UH&FWC; 🇧🇩 Tetuljhora, Dhaka Division, Bangladesh

MCH-Unit, Upazilla Health Center; 🇧🇩 Savar, Dhaka, Bangladesh

Chartarapur UH & FWC; 🇧🇩 Chandrapur, Rajshahi, Bangladesh

Goyeshpur UH &FWC; 🇧🇩 Goyespur, Rajshahi, Bangladesh

MCH Unit, Sadar Upazilla; 🇧🇩 Pabna, Rajshahi, Bangladesh

Pabna MCWC; 🇧🇩 Pabna, Rajshahi, Bangladesh

Mohammadpur Fertility Services and Training Center; 🇧🇩 Dhaka, Bangladesh