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) logo

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)

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

Trial contacts and locations

0

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Central trial contact

Swati B Joshipura, DO; Dr. Jack Stecher, MD

Data sourced from clinicaltrials.gov

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