NCT07362992 Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
| NCT ID | NCT07362992 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Wolfson Medical Center |
| Condition | Cesarean Delivery |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2026-07-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Amichai Rottenstreich
PRINCIPAL INVESTIGATOR
Edith Wolfson Medical center
Frequently Asked Questions
Who can join the NCT07362992 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 51 Years, studying Cesarean Delivery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07362992 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07362992 currently recruiting?
Yes, NCT07362992 is actively recruiting participants. Contact the research team at liatmor1@gmail.com for enrollment information.
Where is the NCT07362992 trial being conducted?
This trial is being conducted at Holon, Israel, Kfar Saba, Israel, Petah Tikva, Israel, Rehovot, Israel.
Who is sponsoring the NCT07362992 clinical trial?
NCT07362992 is sponsored by Wolfson Medical Center. The principal investigator is Amichai Rottenstreich at Edith Wolfson Medical center. The trial plans to enroll 112 participants.