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Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
Sponsor: Wolfson Medical Center
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
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.
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