Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery (NCT07362992) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
Israel112 participantsStarted 2026-01-01
Plain-language summary
The goal of this clinical trial is to learn whether applying topical tranexamic acid (TXA) directly to the uterine incision during cesarean delivery can reduce surgical bleeding compared to placebo. The study will include pregnant women aged 18-51 undergoing elective cesarean delivery at term (37 weeks or more).
The main questions it aims to answer are:
* Does topical TXA shorten uterine closure time?
* Does topical TXA reduce the need for additional hemostatic sutures? Researchers will compare women receiving topical TXA to those receiving placebo (normal saline) to see if TXA reduces intraoperative bleeding and improves surgical outcomes.
Participants will:
* Be randomly assigned to receive either topical TXA or placebo during cesarean delivery.
* Have standard surgery and postoperative care identical in both groups.
* Provide routine clinical data, including hemoglobin levels and recovery outcomes, from their medical records.
Who can participate
Age range
18 Years – 51 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:
* Women aged 18 to 51 years
* Singleton pregnancy
* Elective cesarean delivery scheduled at ≥37+0 weeks of gestation
* First or second cesarean delivery only
* Low transverse uterine incision planned
* Double-layer uterine closure using 1-0 Vicryl sutures
* Ability to provide written informed consent
Exclusion Criteria:
* Known allergy or hypersensitivity to tranexamic acid (TXA)
* History of bleeding or coagulation disorders
* Previous postpartum hemorrhage
* Placenta previa or placenta accreta spectrum
* Presence of uterine myomas
* Current use of anticoagulant or antiplatelet medications
* Planned or intraoperative conversion to general anesthesia
* Known uterine malformations
* Known bleeding tendency or thromboembolic disease
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
1
Uterine closure time (minutes)
Timeframe: Intraoperative (during the index cesarean delivery)
2
Number of additional hemostatic sutures (count)
Timeframe: Intraoperative (during the index cesarean delivery)