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
About this trial
This is an interventional supportive care trial for Postpartum Hemorrhage
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
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
NCT ID
NCT02735733
First Posted
April 7, 2016
Last Updated
April 20, 2016
Sponsor
Baylor Research Institute
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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