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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
mohamed ayedi, Hédi Chaker Hospital
ClinicalTrials.gov Identifier:
NCT01599468
First received: May 14, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Post Partum Hemorrhage
Drug: Tranexamic Acid
Drug: saline serum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Hédi Chaker Hospital:

Primary Outcome Measures:
  • volume blood loss [ Time Frame: within 5 days after delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • transfusion rates. [ Time Frame: within 5 days after delivery ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: exacyl
Placebo Comparator: placebo Drug: saline serum
The Placebo group received normal saline with the same volumes
Other Name: normal saline; NaCl 0.9%

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01599468

Locations
Tunisia
Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care
Sfax, Tunisia, 3029
Sponsors and Collaborators
Hédi Chaker Hospital
Investigators
Principal Investigator: mohamed ayedi hedi chaker university hospital of sfax, tunisia
  More Information

Publications:
Responsible Party: mohamed ayedi, Principal Investigator, Hédi Chaker Hospital
ClinicalTrials.gov Identifier: NCT01599468     History of Changes
Other Study ID Numbers: TXA-1
Study First Received: May 14, 2012
Last Updated: May 21, 2012
Health Authority: Tunisia: Ministry of Public Health

Keywords provided by Hédi Chaker Hospital:
post partum hemorrhage
transfusion
tranexamic acid

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014