Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
Mifepristone and misoprostol
Services Research Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1738 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
MCH-Unit, Upazilla Health Center
Savar Upazila, BangladeshTetulzhora UH&FWC
Tetuljhora, BangladeshChartarapur UH & FWC
Chandrapur, Bangladesh