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

May 21, 2012 updated by: mohamed ayedi, Hédi Chaker Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sfax, Tunisia, 3029
        • Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: saline serum
The Placebo group received normal saline with the same volumes
Other Names:
  • normal saline; NaCl 0.9%
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
volume blood loss
Time Frame: within 5 days after delivery
within 5 days after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
transfusion rates.
Time Frame: within 5 days after delivery
within 5 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hédi Chaker Hospital

Investigators

  • Principal Investigator: mohamed ayedi, hedi chaker university hospital of sfax, tunisia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2012

Last Update Submitted That Met QC Criteria

May 21, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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