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Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

Primary Purpose

Postpartum Hemorrhage， Cesarean Section

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage， Cesarean Section focused on measuring postpartum hemorrhage， cesarean section， tranexamic acid

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • gestational week more than 37;
  • to delivery by cesarean section;
  • informed consent form signed

Exclusion Criteria:

  • Any known renal or liver disorders
  • History of venous or arterial thrombosis
  • Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
  • Do cesarean section because of active bleeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tranexamic acid

    placebo

    Arm Description

    Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section

    NS 10ml IV in 2 minutes after the baby delivered during ceasarean section

    Outcomes

    Primary Outcome Measures

    postpartum hemorrhage

    Secondary Outcome Measures

    the amount of postpartum bleeding

    Full Information

    First Posted
    October 15, 2016
    Last Updated
    October 17, 2016
    Sponsor
    Shanghai First Maternity and Infant Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02936661
    Brief Title
    Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai First Maternity and Infant Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage， Cesarean Section
    Keywords
    postpartum hemorrhage， cesarean section， tranexamic acid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    6700 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic acid
    Arm Type
    Experimental
    Arm Description
    Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    NS 10ml IV in 2 minutes after the baby delivered during ceasarean section
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    postpartum hemorrhage
    Time Frame
    24h after the cesarean section
    Secondary Outcome Measure Information:
    Title
    the amount of postpartum bleeding
    Time Frame
    24h after the cesarean section

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: gestational week more than 37; to delivery by cesarean section; informed consent form signed Exclusion Criteria: Any known renal or liver disorders History of venous or arterial thrombosis Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker. Do cesarean section because of active bleeding

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

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