NCT01599468

Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery

Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Hédi Chaker Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery. This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.

Conditions

• Post Partum Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
DRUG	saline serum	The Placebo group received normal saline with the same volumes

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-05-16
• Last updated: 2012-05-22

Locations

1 site across 1 country: Tunisia