NCT05759156

Tranexamic Acid in Patients for Caesarian Delivery.

Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

Conditions

• Postpartum Hemorrhage
• Cesarean Section Complications
• Obstetric Anesthesia Problems

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-02-05
• Completion: 2024-02-10
• First posted: 2023-03-08
• Last updated: 2025-02-04

Locations

1 site across 1 country: Pakistan