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Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa

Primary Purpose

Postpartum Haemorrage Sever Bleeding After Delivery

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Medical Research Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Haemorrage Sever Bleeding After Delivery focused on measuring obstetric bleeding placenta previa

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 -38 Body mass index <30 , Diagnosis of placenta previa

Exclusion Criteria:

  • patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .

other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.

type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    tranexamic acid group

    placebo group

    Arm Description

    tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section

    the control group will receive 500 cc of ringer lactate 20 minute before cesarean section

    Outcomes

    Primary Outcome Measures

    Amount of Actual blood loss in each group
    observational

    Secondary Outcome Measures

    Difference in haemoglobin before operation and 24 hours after operation
    observational

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    February 17, 2016
    Sponsor
    Medical Research Council
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02688127
    Brief Title
    Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
    Official Title
    Efficacy of Tranexamic Acid In Reducing Blood Loss Among Pregnant Women During Cesarean Section Because Of Placenta Previa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical Research Council

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluate role of tranexamic acid in reducing blood loss among pregnant women undergoing cesarean section because of placenta previa .Half of participants will receive tranexamia acid drug While the other half will receive placebo.
    Detailed Description
    Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after cesarean section . Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid lysine and its action is to reduce blood loss

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Haemorrage Sever Bleeding After Delivery
    Keywords
    obstetric bleeding placenta previa

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tranexamic acid group
    Arm Type
    Experimental
    Arm Description
    tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    the control group will receive 500 cc of ringer lactate 20 minute before cesarean section
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    cyclo kapron
    Intervention Description
    tranexamic acid or placebo are given before cesarean section in patient with placenta previa
    Primary Outcome Measure Information:
    Title
    Amount of Actual blood loss in each group
    Description
    observational
    Time Frame
    6hour after operation
    Secondary Outcome Measure Information:
    Title
    Difference in haemoglobin before operation and 24 hours after operation
    Description
    observational
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18 -38 Body mass index <30 , Diagnosis of placenta previa Exclusion Criteria: patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy . other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus. type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa

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