CompletedPhase 4

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

Bangladesh1,738 participantsStarted 2012-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

successful menstrual regulation without the need for a surgical evacuation

Timeframe: 14 days

Trial details

NCT IDNCT01798017

SponsorGynuity Health Projects

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

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