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Recruiting
NCT07362992
Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery
Conditions: Cesarean Delivery, Postpartum Hemorrhage (PPH), Intraoperative Blood Loss, Hemostasis
Sex: Female
Ages: 18 Years – 51 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 112
Sponsor: Wolfson Medical Center
Location: Edith Wolfson Medical Center Holon Central District
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.
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
Source: ClinicalTrials.gov (NCT07362992). StuddyBuddy aggregates publicly available trial information.