Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemostasis; Postpartum Hemorrhage (PPH); Cesarean Delivery; Intraoperative Blood Loss
• Intervention / Treatment: Drug: Tranexamic Acid (Topical); Other: Normal Saline (Placebo)

Detailed Description

Cesarean delivery carries a recognized risk of significant intraoperative bleeding despite standard uterotonic use and established surgical techniques. Tranexamic acid (TXA), an antifibrinolytic medication, reduces surgical blood loss when administered intravenously, but little is known about the effectiveness of topical TXA applied directly to the uterine incision during cesarean delivery. Evidence from other surgical fields suggests that topical TXA may reduce bleeding with minimal systemic absorption.

This study is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate whether topical TXA decreases intraoperative bleeding during elective cesarean delivery at term. A total of 112 participants will be randomized in a 1:1 ratio to receive either TXA (500 mg diluted in 15 mL saline) or an identical-appearing saline placebo. The study drug is applied by spraying the solution directly onto the uterine incision after placental delivery and before each layer of uterine closure. Randomization will be stratified by site, and allocation will be concealed using sequentially numbered envelopes opened by a scrub nurse.

All cesarean procedures will follow a standardized operative technique to minimize variability. Intraoperative and postoperative data will be collected from medical records, including operative characteristics, perioperative hemoglobin values, use of additional hemostatic measures, length of stay, and maternal or neonatal complications. Safety monitoring will focus on thromboembolic events, allergic reactions, and postoperative infections, with periodic review by an independent safety officer.

This trial aims to determine whether a localized, low-cost antifibrinolytic intervention can improve hemostasis during cesarean delivery and potentially be incorporated into routine surgical practice.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Liat Mor; Phone Number: +972546738294; Email: liatmor1@gmail.com

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Rehovot, Israel
    • Kaplan Medical Center
  • Central District
    • Holon, Central District, Israel, 5834468
      • Edith Wolfson Medical Center
      • Contact: Phone Number: 0546738294

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Tranexamic Acid (TXA) Group; Participants in this group will receive topical tranexamic acid (TXA) applied directly to the uterine incision during cesarean delivery. After the baby and placenta are delivered, the surgeon will spray a solution containing 500 mg of TXA (one ampule, 5 mL) diluted in 15 mL of normal saline onto the uterine incision before suturing begins. After the first layer of sutures is placed, a second syringe of the same TXA solution will be sprayed before the second layer of closure. All other aspects of the surgical technique and postoperative care will follow standard practice.	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 Names: Hexakapron
Placebo Comparator: Placebo (Normal Saline) Group; Participants in this group will receive a placebo solution of normal saline applied in the same manner and at the same time points as in the TXA group. After the baby and placenta are delivered, the surgeon will spray 20 mL of sterile saline onto the uterine incision before closure, and again before completing the second layer of sutures. All other surgical and postoperative procedures will be identical to those in the TXA group.	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.; Other Names: NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine closure time (minutes)	Time from placement of the first uterine stitch to completion of the final uterine stitch including any additional hemostatic sutures (In minutes)	Intraoperative (during the index cesarean delivery)
Number of additional hemostatic sutures (count)	Total number of extra hemostatic stitches needed for bleeding control beyond the routine two-layer uterine closure	Intraoperative (during the index cesarean delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated intraoperative blood loss (mL)	Blood loss estimated by the operating surgeon during the cesarean delivery, recorded at the end of the procedure using standardized estimation protocols.	Intraoperative (during the index cesarean delivery)
Change in hemoglobin levels	Difference between preoperative hemoglobin concentration and hemoglobin measured 16-24 hours after surgery, expressed in g/dL.	16-24 hours postoperatively
Need for additional uterotonic agents	Administration of additional uterotonic medications beyond routine prophylactic Oxycontin during surgery and up to 24 postoperative	Intra-operative to 24 hours postoperative
Need for blood transfusion	Incidence of red blood cell transfusion due to surgical blood loss or postoperative anemia.	within 30 days postoperativly
Duration of hospital admission (days)	Number of days from the cesarean delivery to hospital discharge.	Postoperative within 30 days from delivery
Postoperative complications	Occurrence of any postoperative maternal complications, including fever, endometritis, wound infection, thromboembolic events, or reoperation	Up to 30 days after surgery
Post-discharge emergency department visits or hospital readmissions	Any maternal emergency department visits or readmissions related to the delivery within one month of cesarean section.	Within 30 days postpartum

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Collaborators: Rabin Medical Center; Meir Medical Center; Kaplan Medical Center
• Investigators: Principal Investigator: Amichai Rottenstreich, Edith Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Postpartum Hemorrhage; Cesarean Delivery; Cesarean Section; Tranexamic Acid; Maternal Outcomes; Intraoperative Bleeding; Elective Cesarean; Topical Tranexamic Acid; Hexakapron; Blood Loss Prevention; Uterine Closure
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage; Blood Loss, Surgical; Organic Chemicals; Pharmaceutical Preparations; Carboxylic Acids; Inorganic Chemicals; Chlorine Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Chlorides; Hydrochloric Acid; Tranexamic Acid; Saline Solution; Sodium Chloride
• Other Study ID Numbers: 0191-25-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No