Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section

Not Applicable

Not yet recruiting

• Conditions: Pregnant Women Undergoing Cesarean Delivery
• Interventions: Drug: Tranexamic Acid; Other: Placebo

• Registration Number: NCT07078942
• Lead Sponsor: Chulalongkorn University

Brief Summary

The purpose of this study is to asses the effect of preoperative prophylactic intravenous tranexamic acid on perioperative blood loss in pregnant women undergoing cesarean section

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Study Start: 2025-07-20
• Study First Posted: 2025-07-22
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-28
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

• pregnant women with gestational age 37-42 weeks
• undergoing cesarean delivery with indication as follows: placenta previa, severe preeclampsia, myoma uteri, fetal macrosomia, polyhydramnios, grand multiparity ≥ 5 deliveries, prolonged labor, etc.

Exclusion Criteria

• history of allergy to tranexamic acid
• history of venous thromboembolism (Deep vein thrombosis, Pulmonary embolism)
• history of arterial thrombosis (Myocardial infarction, Stroke)
• history of seizure, convulsion
• have underlying of cardiovascular, renal or liver disease
• using of antiplatelet or anticoagulant within 1 week before operation
• placenta accreta spectrum
• abruptio placenta
• Eclampsia or HELLP (Hemolysis Elevated Liver Low Platelet) syndrome
• Failed operative vaginal delivery
• Multifetal gestation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	Tranexamic acid (1 g) 20 ml intravenous preoperation
Placebo	Placebo	Normal saline 20 ml intravenous preoperation

Primary Outcome Measures

Name	Time	Method
Blood loss	From enrollment to the end of operation	blood loss in ml

Secondary Outcome Measures

Name	Time	Method
early postpartum hemorrhage	From starting operation to 24-hour postoperation	percentage of early postpartum hemorrhage
delayed postpartum hemorrhage	From starting operation to 6 weeks postpartum	percentage of delayed postpartum hemorrhage
Adverse effects	from enrollment to 6 weeks postpartum	percentage of adverse effects
Neonatal outcomes	from starting operation to 10 minutes after birth	Apgar scores (0 is the minimum value and 10 is maximum value, and higher scores mean a better outcome)

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand