A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility, acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not responding to first line of treatment.
Who can participate
Age range
18 Years – 49 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:
* All women who presented with atraumatic postpartum hemorrhage, refractory to first-line treatment (uterine massage and oxytocin) and who will give their consent will be included in the study and will be randomized
Exclusion Criteria:
* Women known to have allergy to latex, or presenting with clinical chorioamnionitis or primary hemorrhage caused by cervical-vaginal lacerations, a uterine rupture, or a placenta accreta will be excluded.
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 tested something called an 'S-Condom uterine tamponade' to stop postpartum bleeding — can you explain how this device works and whether it's something that might be used at the hospital where I'm delivering?
2Since this trial has already been completed and was measuring how quickly bleeding could be stopped, have the results been published yet, and do they show any meaningful difference compared to other methods for managing postpartum hemorrhage?
3This was a randomized controlled trial for atraumatic postpartum hemorrhage specifically — how does my own risk profile for PPH compare to the type of patients who were enrolled in this study?
4Given that this trial is now completed, is the S-Condom tamponade approach something my care team is already using, considering as a standard option, or is it still considered experimental at this point?
5What are the existing standard treatments for postpartum hemorrhage that I should understand first, and how would a device like the one tested in this trial fit into or compare with those options for my birth plan?
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
Time required to stop bleeding
Timeframe: 2 years
Trial details
NCT IDNCT05559840
SponsorMamms Institute of Fistula and Womens Health