Status:
COMPLETED
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
Lead Sponsor:
Gynuity Health Projects
Conditions:
Menstrual Regulation
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
1738 Patients enrolled
Trial Details
Trial ID
NCT01798017
Start Date
November 1 2012
End Date
August 1 2015
Last Update
December 10 2015
Active Locations (8)
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1
Aminbazar Rural Dispensary
Aminbazar, Dhaka Division, Bangladesh
2
MCH-Unit, Upazilla Health Center
Savar Upazila, Dhaka Division, Bangladesh
3
Tetulzhora UH&FWC
Tetuljhora, Dhaka Division, Bangladesh
4
Chartarapur UH & FWC
Chandrapur, Rajshahi Division, Bangladesh