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Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold Bakri Balloon
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • women 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri

Exclusion Criteria:

  • anyone outside of the specified age group
  • anyone who declines to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Room temperature arm

    Cold arm

    Arm Description

    Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at room temperature.

    Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at approximately 32 degrees F for the study group.

    Outcomes

    Primary Outcome Measures

    Total measured blood loss

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2016
    Last Updated
    April 20, 2016
    Sponsor
    Baylor Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02735733
    Brief Title
    Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?
    Official Title
    Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    June 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baylor Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine if a balloon tamponade catheter filled with cold saline is more effective than a catheter filled with room temperature saline in controlling post partum hemorrhage.
    Detailed Description
    When post partum hemorrhage occurs one mode of therapy is to place a balloon tamponade catheter into the uterus to compress the bleeding vessels. When this mode of therapy has been chosen by the attending physician the patient will be randomized to either the room temperature arm (control) or the cold arm (study). The balloon catheter is placed through the vagina into the uterus and inflated using normal saline; room temperature for the control group and approximately 32 degrees F for the study group. Traction is placed on the catheter to tamponade the vessels in the lower uterine segment. Blood from the uterus passes through a central lumen of the balloon and will be collected and measured. Total measured blood loss for each group will be compared.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Room temperature arm
    Arm Type
    Active Comparator
    Arm Description
    Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at room temperature.
    Arm Title
    Cold arm
    Arm Type
    Experimental
    Arm Description
    Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at approximately 32 degrees F for the study group.
    Intervention Type
    Device
    Intervention Name(s)
    Cold Bakri Balloon
    Intervention Description
    In the room temperature arm, the bakri balloon will be inserted through the vagina and placed inside the uterus and filled with room temperature saline. In the cold arm, the same intervention will performed, however, the bakri balloon will be filled with cold saline at 32 degrees Fahrenheit.
    Primary Outcome Measure Information:
    Title
    Total measured blood loss
    Time Frame
    time frame is approximately 24 hours, until the balloon catheter is removed from the uterus

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: women 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri Exclusion Criteria: anyone outside of the specified age group anyone who declines to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Swati B Joshipura, DO
    Phone
    510-754-7093
    Email
    swati.joshipura@bswhealth.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Jack Stecher, MD
    Phone
    214-820-2126
    Ext
    3075
    Email
    jack.stecher@bswhealth.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32609374
    Citation
    Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
    Results Reference
    derived

    Learn more about this trial

    Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?

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