Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

NCT07362992 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 0191-25-WOMC
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 4

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.

Conditions

Intraoperative Blood Loss; Hemostasis; Cesarean Delivery; Postpartum Hemorrhage (PPH)

Keywords

Tranexamic Acid; Topical Tranexamic Acid; Hexakapron; Cesarean Delivery; Cesarean Section; Elective Cesarean; Postpartum Hemorrhage; Intraoperative Bleeding; Blood Loss Prevention; Uterine Closure; Randomized Controlled Trial; Maternal Outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Estimated intraoperative blood loss (mL)

  Intraoperative (during the index cesarean delivery)

• Change in hemoglobin levels

  16-24 hours postoperatively

• Need for additional uterotonic agents

  Intra-operative to 24 hours postoperative

• Need for blood transfusion

  within 30 days postoperativly

• Duration of hospital admission (days)

  Postoperative within 30 days from delivery

Study Arms (2)

Topical Tranexamic Acid (TXA) Group

EXPERIMENTAL

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)

Placebo (Normal Saline) Group

PLACEBO COMPARATOR

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)

Interventions

Tranexamic Acid (Topical) DRUG

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.

Also known as: Hexakapron

Topical Tranexamic Acid (TXA) Group

Normal Saline (Placebo) OTHER

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.

Also known as: NaCl 0.9%

Placebo (Normal Saline) Group

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead
• Rabin Medical Center: collaborator
• Meir Medical Center: collaborator
• Kaplan Medical Center: collaborator

Study Sites (4)

Edith Wolfson Medical Center

Holon, Central District, 5834468, Israel

Location

Meir medical center

Kfar Saba, Israel

Location

Rabin medical center

Petah Tikva, Israel

Location

Kaplan medical center

Rehovot, Israel

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Blood Loss, Surgical

Interventions

Tranexamic Acid; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Amichai Rottenstreich

  Edith Wolfson Medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liat Mor

CONTACT

+972546738294; liatmor1@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)