Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-51
SponsorWolfson Medical Center

About this 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.

Eligibility criteria

Qualifiers

Women aged 18 to 51 years

Singleton pregnancy

Elective cesarean delivery scheduled at ≥37+0 weeks of gestation

First or second cesarean delivery only

Disqualifiers

Known allergy or hypersensitivity to tranexamic acid (TXA)

History of bleeding or coagulation disorders

Previous postpartum hemorrhage

Placenta previa or placenta accreta spectrum

Trial design

Treatments tested in this trial

  • Tranexamic Acid (Topical)
  • Normal Saline (Placebo)

Treatment groups

112 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wolfson Medical Center

Lead sponsor

Rabin Medical Center

Collaborator

Meir Medical Center

Collaborator

Kaplan Medical Center

Collaborator