Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India (NCT01462422) | Clinical Trial Compass
CompletedNot Applicable
Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India
India3,032 participantsStarted 2011-12
Plain-language summary
This study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of PPH. The study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of PPH. This cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of PPH care using misoprostol.
Who can participate
Age range
15 Years – 45 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
. delivering at home or sub-center with an auxilliary nurse midwife (ANM)
. able and willing to provide informed consent
. meeting Ministry of Health Guidelines for home or sub-center delivery
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.
1This trial looked at giving misoprostol at the community level in India to prevent postpartum hemorrhage — how does that community-based approach compare to what would happen in my own delivery setting, and would misoprostol be an option for me?
2The trial measured how many women had a hemoglobin level of 7.8 g/dL or below after delivery, which suggests a concern about severe blood loss leading to anemia — based on my own health history, am I at higher risk for postpartum hemorrhage or low hemoglobin after birth?
3Since this trial is completed, has the data shown any meaningful difference in hemoglobin levels or hemorrhage rates with misoprostol, and how does that evidence compare to the standard medications you would use during my delivery?
4Misoprostol is a medication that can have side effects like shivering, fever, and nausea — how would you weigh those risks against its potential benefits given my specific pregnancy and birth plan?
5Are there standard-of-care options already available at my planned delivery location that address postpartum hemorrhage prevention, and would those be considered more appropriate for me than approaches studied in a community-based trial like this one?
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
1
Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL
Timeframe: 72 hours (plus or minus 8 hours) after delivery