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

NCT02735733 | Withdrawn

• 1 other identifier: 016-092
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Total measured blood loss

  time frame is approximately 24 hours, until the balloon catheter is removed from the uterus

Study Arms (2)

Room temperature arm

ACTIVE COMPARATOR

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

Device: Cold Bakri Balloon

Cold arm

EXPERIMENTAL

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.

Device: Cold Bakri Balloon

Interventions

Cold Bakri Balloon DEVICE

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.

Cold arm; Room temperature arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri

You may not qualify if:

• anyone outside of the specified age group
• anyone who declines to participate in the study

Sponsors & Collaborators

• Baylor Research Institute: lead

Related Publications (1)

• Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

  PMID: 32609374 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: April 8, 2016
• Study Completion: April 8, 2016
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share