Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
NCT01798017 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1738
Last updated 2015-12-10
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.
Conditions
- Menstrual Regulation
Interventions
- DRUG
-
Mifepristone and misoprostol
Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol
Sponsors & Collaborators
-
Gynuity Health Projects
lead OTHER
Principal Investigators
-
Hillary J Bracken, PhD · Gynuity Health Projects
-
Laura Reichenbach, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-08-31
Countries
- Bangladesh
Study Locations
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