Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 6 hour IUBT placement
|
Device: Intrauterine balloon tamponade
Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.
|
| Active Comparator: 18 hour IUBT placement
|
Device: Intrauterine balloon tamponade
Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.
|
Outcome Measures
Primary Outcome Measures
- Quantitative blood loss [18 hours]
total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads
Secondary Outcome Measures
- Postpartum hemorrhage related outcomes [during admission]
return to the OR, replacement of the IUBT, hysterectomy, pelvic artery embolization
- Hematocrit [during admission]
change in hematocrit from admission to discharge
- Postpartum length of stay [during admission]
Length of stay in hours
- Endometritis [during admission]
diagnosed postpartum
- Chorioamnionitis [during admission]
requiring more than one dose of antibiotics postpartum
- Transfusion of packed red blood cells [during admission]
after IUBT placement
- Maternal-infant bonding [during admission]
measured by the mother-to-infant bonding scale (MIBS), scale 0-27, higher score indicates worse maternal-infant bonding
- Maternal pain [during admission]
measured by the visual analogue scale (VAS), scale 0-10, higher score indicates worse pain
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Denver Health Hospital | Denver | Colorado | United States | 80204 |
Sponsors and Collaborators
- Denver Health and Hospital Authority
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-3070