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NOT YET RECRUITING
NCT07362992
EARLY_PHASE1

Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

Sponsor: Wolfson Medical Center

View on ClinicalTrials.gov

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.

Official title: Does Topical Use of Tranexamic Acid During a Cesarean Delivery Reduce Intra-surgical Bleeding? A Randomized ,Multi-center Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 51 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2026-01-23

Healthy Volunteers

Yes

Interventions

DRUG

Tranexamic Acid (Topical)

This intervention involves topical application of tranexamic acid (TXA) directly to the uterine incision during cesarean delivery, rather than the conventional intravenous route. A solution containing 500 mg of TXA (one ampule, 5 mL) diluted in 15 mL of normal saline is sprayed evenly over the uterine incision surface after placental delivery and before suturing. A second application of the same solution is sprayed before the second layer of uterine closure. This localized, site-directed use is designed to reduce intraoperative bleeding with minimal systemic absorption, distinguishing it from previously studied intravenous TXA regimens.

OTHER

Normal Saline (Placebo)

This comparator intervention involves topical application of sterile normal saline to the uterine incision at the same time points as in the TXA arm - after placental delivery and before each layer of uterine closure. The saline is visually indistinguishable from the TXA solution, ensuring blinding of participants and surgical teams. This placebo control enables a direct comparison to determine whether the topical TXA application provides added benefit in reducing intraoperative bleeding.

Locations (4)

Edith Wolfson Medical Center

Holon, Central District, Israel

Meir medical center

Kfar Saba, Israel

Rabin medical center

Petah Tikva, Israel

Kaplan medical center

Rehovot, Israel