Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

Official title

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

Overview

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.

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, 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.

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
• 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.

Primary outcome measures

• Uterine closure time (minutes) [Time frame: Intraoperative (during the index cesarean delivery)]
• Number of additional hemostatic sutures (count) [Time frame: Intraoperative (during the index cesarean delivery)]

Secondary outcome measures (7)

• Estimated intraoperative blood loss (mL) [Time frame: Intraoperative (during the index cesarean delivery)]
• Change in hemoglobin levels [Time frame: 16-24 hours postoperatively]
• Need for additional uterotonic agents [Time frame: Intra-operative to 24 hours postoperative]
• Need for blood transfusion [Time frame: within 30 days postoperativly]
• Duration of hospital admission (days) [Time frame: Postoperative within 30 days from delivery]
• Postoperative complications [Time frame: Up to 30 days after surgery]
• Post-discharge emergency department visits or hospital readmissions [Time frame: Within 30 days postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Israel · 4 centers

• Edith Wolfson Medical Center — Holon
• Meir medical center — Kfar Saba
• Rabin medical center — Petah Tikva
• Kaplan medical center — Rehovot

Identifiers

NCT: NCT07362992 · 0191-25-WOMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗