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

Hédi Chaker Hospital

Status and phase

Completed

Phase 4

Conditions

Post Partum Hemorrhage

Treatments

Drug: saline serum

Drug: Tranexamic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01599468

TXA-1

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.