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Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

Primary Purpose

Placenta Previa

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa focused on measuring Cesarean section, placenta previa, Tranexamic acid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Term pregnancy (more than 37 weeks of gestation)
  • Diagnosis of placenta previa was confirmed by ultrasound
  • The patient hemoglobin percentage is more than 10 mg/dl

Exclusion Criteria:

  • Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
  • Emergency lower segment cesarean section
  • Associated medical comorbidities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Cases

    Controls

    Arm Description

    Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa

    Control group will not receive Tranexamic acid

    Outcomes

    Primary Outcome Measures

    intra operative blood loss in ml
    Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss

    Secondary Outcome Measures

    Full Information

    First Posted
    January 10, 2017
    Last Updated
    February 21, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03060889
    Brief Title
    Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
    Official Title
    Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
    Detailed Description
    Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Previa
    Keywords
    Cesarean section, placenta previa, Tranexamic acid

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Cases
    Arm Type
    Active Comparator
    Arm Description
    Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa
    Arm Title
    Controls
    Arm Type
    No Intervention
    Arm Description
    Control group will not receive Tranexamic acid
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Intervention Description
    10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion
    Primary Outcome Measure Information:
    Title
    intra operative blood loss in ml
    Description
    Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss
    Time Frame
    intraoperative during cesarean section

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Term pregnancy (more than 37 weeks of gestation) Diagnosis of placenta previa was confirmed by ultrasound The patient hemoglobin percentage is more than 10 mg/dl Exclusion Criteria: Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies Emergency lower segment cesarean section Associated medical comorbidities

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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