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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post Partum Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: saline serum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid, post partum hemorrhage<br> | Drug: Tranexamic Acid<br>* 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours<br>* Other names: exacyl;|
| Placebo Comparator: placebo<br> | Drug: saline serum<br>* The Placebo group received normal saline with the same volumes<br>* Other names: normal saline; NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume blood loss |  | within 5 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion rates. |  | within 5 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post partum hemorrhage, transfusion, tranexamic acid