A Trial of Sublingual Misoprostol to Reduce Primary Postpartum Haemorrhage After Vaginal Delivery (NCT05079061) | Clinical Trial Compass
UnknownPhase 4
A Trial of Sublingual Misoprostol to Reduce Primary Postpartum Haemorrhage After Vaginal Delivery
1,300 participantsStarted 2022-04
Plain-language summary
The objective of the randomized controlled study is to compare combination of sublingual misoprostol and routine uterotonics versus routine uterotonics alone on PPH in low risk women after vaginal delivery. The hypothesis is that combination of sublingual misoprostol and routine uterotonics is more effective than routine uterotonics alone in reduction of PPH in low risk women after vaginal delivery.
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:
* All women age ≥ 18 years (age of legal consent)
* Singleton pregnancy \>= 34 weeks
Exclusion Criteria:
* Women planning for Caesarean section
* Women with known risk factors for PPH, including grand multiparity (\>=4), multiple pregnancy, fibroid with size \>4cm, history of PPH, placenta previa, large-for-gestational age fetus (defined as EFW \>90th centile), polyhydramnios, and previous Caesarean section.
* Women with bleeding tendency or thrombocytopenia \< 100 x 109/L
* Women on anticoagulant or aspirin
* Women in whom use of misoprostol / syntocinon / syntometrine is contraindicated
* Women with known hypersensitivity to misoprostol / syntocinon / syntometrine
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.