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

Baylor Scott and White Health (BSWH)

Status: Unknown

Conditions: Postpartum Hemorrhage

Treatments: Device: Cold Bakri Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02735733

016-092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Room temperature arm

Active Comparator group

Description:

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

Treatment:

Device: Cold Bakri Balloon

Cold arm

Experimental group

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.

Treatment:

Device: Cold Bakri Balloon