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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Menstrual Regulation

Intervention / Treatment
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* Drug: Mifepristone and misoprostol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone-misoprostol<br>Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol | Drug: Mifepristone and misoprostol<br>* Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful menstrual regulation without the need for a surgical evacuation |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menstrual regulation, mifepristone, misoprostol