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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Menstrual Regulation trials