Topical tranexamic acid to cut blood loss during cesarean delivery
Official title: Does Topical Use of Tranexamic Acid During a Cesarean Delivery Reduce Intra-surgical Bleeding? A Randomized ,Multi-center Trial
Run by Wolfson Medical Center · NCT07362992 · Data updated 2026-11-12
This study tests whether spraying tranexamic acid onto the uterine incision during cesarean delivery can reduce bleeding compared with placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 51 Years |
| Sex | Women only |
| Enrollment | 112 (estimated) |
| Sponsor | Wolfson Medical Center Government |
| Locations | 4 sites (Holon, Central District and 3 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | December 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07362992 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–51 having elective, term, singleton cesarean deliveries with a low transverse incision and planned double-layer uterine closure.
✕Probably not a fit
Patients who do not experience significant intraoperative bleeding or who have contraindications to TXA may not derive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, placebo-controlled trial compares topical tranexamic acid (TXA) to saline given directly to the uterine incision after placental delivery in elective cesarean deliveries at term. Participants are 18-51 years old with singleton pregnancies, assigned 1:1 to TXA or placebo, with standard surgical care in both groups. The primary outcomes include intraoperative blood loss and time to uterine closure, along with the need for additional hemostatic measures. Data on perioperative hemoglobin, length of stay, and maternal/neonatal safety are collected from medical records. The trial uses stratified randomization by site and concealed allocation, with a standardized operative technique to minimize variability.
Why it matters
Potential benefit: If successful, topical TXA could further reduce intraoperative bleeding and reduce the need for additional hemostatic measures during cesarean delivery.
How similar studies have gone: Previous systemic TXA studies show reduced blood loss in cesarean deliveries; topical use in other surgeries suggests potential benefit but is less proven in cesarean context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Edith Wolfson Medical Center
Holon, Central District, Israel Recruiting -
Meir medical center
Kfar Saba, Israel Not yet recruiting -
Rabin medical center
Petah Tikva, Israel Not yet recruiting -
Kaplan medical center
Rehovot, Israel Not yet recruiting
Study contacts
- Principal investigator: Amichai Rottenstreich — Edith Wolfson Medical center
- Study coordinator: Liat Mor
- Email: liatmor1@gmail.com
- Phone: +972546738294
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.