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

Chulalongkorn University

Status and phase: Not yet enrolling; Phase 4

Conditions: Pregnant Women Undergoing Cesarean Delivery

Treatments: Other: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT07078942

0127/68

COA 0685/2025 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 98 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

98 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Description:

Tranexamic acid (1 g) 20 ml intravenous preoperation

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

Normal saline 20 ml intravenous preoperation

Treatment:

Other: Placebo