Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

Wolfson Medical Center (WMC)

Status and phase: Not yet enrolling; Early Phase 1

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

Treatments: Drug: Tranexamic Acid (Topical); Other: Normal Saline (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07362992

0191-25-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups, including a placebo group

Topical Tranexamic Acid (TXA) Group

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid (Topical)

Placebo (Normal Saline) Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Normal Saline (Placebo)