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

Not Applicable

• Conditions: Postpartum Hemorrhage
• Interventions: Device: Cold Bakri Balloon

• Registration Number: NCT02735733
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21
• Study Start: 2016-05
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold arm	Cold Bakri Balloon	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.
Room temperature arm	Cold Bakri Balloon	Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at room temperature.

Primary Outcome Measures

Name	Time	Method
Total measured blood loss	time frame is approximately 24 hours, until the balloon catheter is removed from the uterus