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

NCT01599468 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-05-22

No results posted yet for this study

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.

Conditions

  • Post Partum Hemorrhage

Interventions

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

DRUG

saline serum

The Placebo group received normal saline with the same volumes

Sponsors & Collaborators

  • Hédi Chaker Hospital

    lead OTHER

Principal Investigators

  • mohamed ayedi · hedi chaker university hospital of sfax, tunisia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599468 on ClinicalTrials.gov