NCT01798017

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,738 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menstrual Regulation

Interventions

Type	Name	Description
DRUG	Mifepristone and misoprostol	Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-06-01
• Completion: 2015-08-01
• First posted: 2013-02-25
• Last updated: 2015-12-10

Locations

8 sites across 1 country: Bangladesh