Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

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

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

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. This placebo control enables a direct comparison to determine whether the topical TXA application provides added benefit in reducing intraoperative bleeding.

Sponsors & Collaborators

• Rabin Medical Center

  collaborator OTHER

• Meir Medical Center

  collaborator OTHER

• Kaplan Medical Center

  collaborator OTHER

• Wolfson Medical Center

  lead OTHER_GOV

Principal Investigators

• Amichai Rottenstreich · Edith Wolfson Medical center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

51 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-12-01

Completion

2028-12-31

Countries

• Israel

Study Locations