Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in… (NCT02226588) | Clinical Trial Compass
CompletedPhase 4
Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt
Egypt2,827 participantsStarted 2014-10
Plain-language summary
The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.
Who can participate
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:
* Willing and able to give informed consent
* Vaginal delivery
* Agrees to participate in follow-up interview
* Agrees to have pre- and post-hemoglobin taken
* Delivery at woman's home or at the primary health unit (PHU)
Exclusion Criteria:
* Too advanced into active labor to provide consent
* Known allergy to misoprostol and/or other prostaglandin
* Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
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 compared primary and secondary prevention of postpartum hemorrhage in a community setting in Egypt — how does that community-level approach differ from what I would receive in a hospital, and does that difference matter for my situation?
2Since this was a Phase 4 trial, the medications involved were already approved — can you explain what treatments were being compared and whether any of them are already part of standard care for preventing postpartum hemorrhage after my delivery?
3The trial measured the drop in hemoglobin levels before and after delivery as its main outcome — what does a significant drop in hemoglobin mean for my recovery, and how would doctors monitor and respond to that in my case?
4This trial has already been completed — is the data from it available, and does it change your recommendations about how to prevent or manage postpartum hemorrhage during my delivery?
5Given that this study focused on community-level prevention, would my planned delivery setting — whether at home, a birthing center, or a hospital — affect which prevention approach you would recommend for me?
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
Mean drop in pre- to post-delivery hemoglobin level
Timeframe: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.