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

Phase 4

Completed

• Conditions: Post Partum Hemorrhage
• Interventions: Drug: saline serum; Drug: Tranexamic Acid

• Registration Number: NCT01599468
• Lead Sponsor: Hédi Chaker Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• ASA1 parturients
• aged from 20 to 40
• correct preoperative haemostatic status (prothrombine ratio > 60 % and platelet rate > 100 000),
• cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone

Exclusion Criteria

• abnormal placentation
• severe pre-eclampsia
• coagulopathy and uterine rupture
• the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	saline serum	-
tranexamic acid, post partum hemorrhage	Tranexamic Acid	-

Primary Outcome Measures

Name	Time	Method
volume blood loss	within 5 days after delivery

Secondary Outcome Measures

Name	Time	Method
transfusion rates.	within 5 days after delivery

Trial Locations

Locations (1)

Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care; 🇹🇳 Sfax, Tunisia