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

NCT04467996 | Active Not Recruiting FDA Device

• 1 other identifier: 19-3070
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Quantitative blood loss

  total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads

  18 hours

Secondary Outcomes (8)

• Postpartum hemorrhage related outcomes

  during admission

• Hematocrit

  during admission

• Postpartum length of stay

  during admission

• Endometritis

  during admission

• Chorioamnionitis

  during admission

Study Arms (2)

6 hour IUBT placement

ACTIVE COMPARATOR

Device: Intrauterine balloon tamponade

18 hour IUBT placement

ACTIVE COMPARATOR

Device: Intrauterine balloon tamponade

Interventions

Intrauterine balloon tamponade DEVICE

Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.

18 hour IUBT placement; 6 hour IUBT placement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women at Denver Health and Hospital Authority (DHHA) who have an IUBT placed for postpartum hemorrhage due to uterine atony will be approached for enrollment in the study.

You may not qualify if:

• Women will be excluded from the study if they: are less than 18 years of age; had a cesarean delivery; are unable to consent for themselves; have a preexisting or acquired clotting factor disorder such as von Willebrand or hemophilia, disseminated intravascular coagulation, or therapeutic anticoagulation at time of delivery; would refuse blood product transfusion; have a fetal demise or birth of a previable fetus; or are incarcerated at the time of delivery. Women who do not speak English or Spanish will be offered enrollment if a phone interpreter is available to review the consent, but will be excluded from the survey portion of the study.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Hospital

Denver, Colorado, 80204, United States

Location

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
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician Gynegologist, Assistant Professor

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: October 19, 2020
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)