Clinical trial NCT04467996: Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage
Official title: Evaluation of the Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Hemorrhage, Immediate
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Quantitative blood loss
timeFrame: 18 hours
Secondary outcomes:
measure: Postpartum hemorrhage related outcomes
timeFrame: during admission
measure: Hematocrit
timeFrame: during admission
measure: Postpartum length of stay
timeFrame: during admission
measure: Endometritis
timeFrame: during admission
measure: Chorioamnionitis
timeFrame: during admission
measure: Transfusion of packed red blood cells
timeFrame: during admission
measure: Maternal-infant bonding
timeFrame: during admission
measure: Maternal pain
timeFrame: during admission
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Hospital
state: Colorado
Study officials:
References: