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

Sponsor

Hédi Chaker Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01599468

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Partum Hemorrhage	Drug: Tranexamic Acid Drug: saline serum	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tranexamic acid, post partum hemorrhage	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
Placebo Comparator: placebo	Drug: saline serum The Placebo group received normal saline with the same volumes Other Names: normal saline; NaCl 0.9%

Arm

Intervention/Treatment

Experimental: tranexamic acid, post partum hemorrhage

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

Placebo Comparator: placebo

Drug: saline serum

The Placebo group received normal saline with the same volumes

Other Names:

normal saline; NaCl 0.9%

Outcome Measures

Primary Outcome Measures

volume blood loss [within 5 days after delivery]

Secondary Outcome Measures

transfusion rates. [within 5 days after delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.