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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Mifepristone; Misoprostol

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.