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Completed

NCT Number: NCT01599468

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

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.

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Key information

Conditions

Post Partum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Sfax, Sfax Governorate, 3029, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

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

saline serum

Drug

The Placebo group received normal saline with the same volumes

Other names: normal saline; NaCl 0.9%

Primary outcomes

  1. volume blood loss

    Time frame: within 5 days after delivery

Secondary outcomes

  1. transfusion rates.

    Time frame: within 5 days after delivery

Sponsors and collaborators

Lead sponsor

Hédi Chaker Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 16, 2012
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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