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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Hemorrhage, Immediate

Intervention / Treatment
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* Device: Intrauterine balloon tamponade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 hour IUBT placement<br> | Device: Intrauterine balloon tamponade<br>* Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.<br>|
| Active Comparator: 18 hour IUBT placement<br> | Device: Intrauterine balloon tamponade<br>* Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative blood loss | total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads | 18 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum hemorrhage related outcomes | return to the OR, replacement of the IUBT, hysterectomy, pelvic artery embolization | during admission | 
| Hematocrit | change in hematocrit from admission to discharge | during admission | 
| Postpartum length of stay | Length of stay in hours | during admission | 
| Endometritis | diagnosed postpartum | during admission | 
| Chorioamnionitis | requiring more than one dose of antibiotics postpartum | during admission | 
| Transfusion of packed red blood cells | after IUBT placement | during admission | 
| Maternal-infant bonding | measured by the mother-to-infant bonding scale (MIBS), scale 0-27, higher score indicates worse maternal-infant bonding | during admission | 
| Maternal pain | measured by the visual analogue scale (VAS), scale 0-10, higher score indicates worse pain | during admission |