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Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring tranexamic acid

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age of 28 weeks or more.
  • Chronic Hypertension.
  • Preeclapmsia -Eclampsia.
  • Multiple pregnancy.
  • Uterine Liomyomas.
  • Polyhydraminos.
  • Fetal macrosomia.
  • Associated Thrombocytopenia
  • History of postpartum hemorrhage.

Exclusion Criteria:

  • Patients with rheumatic heart disease.
  • Patients with history Cardiac Valve Replacement.
  • Current or past history of DVT.
  • Women on any anticoagulant therapy.
  • Sensitivity to tranexamic acid
  • Pregnancies with any abnormally implanted or located placenta.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    tranexamic acid group

    non tranexamic (control) group

    Arm Description

    Outcomes

    Primary Outcome Measures

    prevention of postpartum hemorrhage in high risk group
    assessment of intraoperative blood loss

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2017
    Last Updated
    November 22, 2017
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03351686
    Brief Title
    Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section
    Official Title
    The Effect of Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section, a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    April 15, 2017 (Actual)
    Study Completion Date
    April 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage
    Keywords
    tranexamic acid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tranexamic acid group
    Arm Type
    Experimental
    Arm Title
    non tranexamic (control) group
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Intervention Description
    Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.
    Primary Outcome Measure Information:
    Title
    prevention of postpartum hemorrhage in high risk group
    Description
    assessment of intraoperative blood loss
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gestational age of 28 weeks or more. Chronic Hypertension. Preeclapmsia -Eclampsia. Multiple pregnancy. Uterine Liomyomas. Polyhydraminos. Fetal macrosomia. Associated Thrombocytopenia History of postpartum hemorrhage. Exclusion Criteria: Patients with rheumatic heart disease. Patients with history Cardiac Valve Replacement. Current or past history of DVT. Women on any anticoagulant therapy. Sensitivity to tranexamic acid Pregnancies with any abnormally implanted or located placenta.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hanan Nabil, MD
    Organizational Affiliation
    Mansoura University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

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