NCT04467996

Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage

Evaluation of the Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little is known about how long the IUBT should be used once placed. Though it is common to use IUBT for 12-24 hours, the balloon may be equally effective when used for shorter durations of time, which could have beneficial effects for patients and hospitals. The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in controlling postpartum hemorrhage. The specific aims of the proposed study are to determine: 1) whether quantitative blood loss significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3) whether shorter duration of IUBT placement has beneficial effects including shortened postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain prior to maternal discharge from hospital. We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is no clinically significant difference in postpartum blood loss when the balloon is removed 6 hours after placement compared to 18 hours after placement.

Conditions

• Postpartum Hemorrhage, Immediate

Interventions

Type	Name	Description
DEVICE	Intrauterine balloon tamponade	Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.

Timeline

• Start date: 2020-10-19
• Primary completion: 2023-06-01
• Completion: 2026-01-01
• First posted: 2020-07-13
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study