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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02735733
• Other study ID #: 016-092
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2016
• Last updated: April 20, 2016
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Baylor Research Institute
• Contact: Swati B Joshipura, DO
• Phone: 510-754-7093
• Email: swati.joshipura[@]bswhealth.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• Cold 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total measured blood loss		time frame is approximately 24 hours, until the balloon catheter is removed from the uterus	No