Prevention of Postpartum Haemorrhage

Overview

Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Full Title of Study: “Tranexamic Acid for the Prevention of Postpartum Haemorrhage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2021

Detailed Description

This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

Interventions

  • Drug: Tranexamic acid injection
    • 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .

Arms, Groups and Cohorts

  • Active Comparator: Study
    • Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
  • No Intervention: Control
    • control group will not be given tranexamic acid

Clinical Trial Outcome Measures

Primary Measures

  • blood loss
    • Time Frame: immediately after deliver
    • Estimation of blood loss

Secondary Measures

  • blood pressure
    • Time Frame: immediately after delivery
    • blood pressure
  • pulse
    • Time Frame: immediately after delivery
    • pulse
  • temperature
    • Time Frame: immeditely after delivery
    • temperature

Participating in This Clinical Trial

Inclusion Criteria

  • Women at high risk for postpartum hemorrhage after cesarean section Exclusion Criteria:

  • women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Benha University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Abou Bakr Mohamed El Nashaar, professor – Benha University
  • Overall Official(s)
    • Shaimaa Ezzat, Principal Investigator, Police Hospital
  • Overall Contact(s)
    • Aboubakr Elnashar, MD, 00201066934749, elnashar53@hotmail.com

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