Trial | NCT01599468  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    74
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.
Study Started
Jul 31
2011
Primary Completion
Apr 30
2012
Study Completion
Apr 30
2012
Last Update
May 22
2012
Estimate

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

  • Other names: exacyl

Drug saline serum

The Placebo group received normal saline with the same volumes

  • Other names: normal saline; NaCl 0.9%

tranexamic acid, post partum hemorrhage Experimental

placebo Placebo Comparator

Criteria 

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.
No Results Posted