Postpartum Hemorrhage
Conditions
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.
Interventions
DEVICECold Bakri Balloon
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.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total measured blood loss | time frame is approximately 24 hours, until the balloon catheter is removed from the uterus |
Outcome results
None listed