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Intrauterine Balloon Tamponade Duration for Postpartum Hemorrhage: A Randomized Controlled Trial
Nicole Larrea1, Katlynn Adkins, Joshua Durfee
1Denver Health and Hospital Authority, University of Colorado School of Medicine, and the Center for Health Systems Research, Denver Health and Hospital Authority, Denver, Colorado; and the University of Vermont Medical Center, Robert Larner, M.D. College of Medicine, Burlington, Vermont.
Objective:
To determine whether an intrauterine balloon tamponade duration of 6 hours is noninferior to a duration of 18 hours for controlling bleeding after vaginal delivery, as measured by quantitative blood loss.
Methods:
In this pragmatic randomized trial of noninferiority, a 6-hour duration of intrauterine balloon tamponade usage for postpartum hemorrhage (PPH) control was compared with an 18-hour duration. We randomized participants with PPH due to uterine atony after vaginal delivery to an intrauterine balloon tamponade duration of 6 hours or 18 hours in a 1:1 ratio using stratified block randomization based on quantitative blood loss at the time of intrauterine balloon tamponade placement. The primary outcome was the total quantitative blood loss from the placement of the intrauterine balloon tamponade to 18 hours postplacement. Sixty-four participants were estimated to be required to determine whether total quantitative blood loss between groups was above our chosen noninferiority margin of 250 mL. Noninferiority t tests were considered noninferior at P <.05. Secondary outcomes included measures of escalation in PPH management.
Results:
From October 2020 through May 2023, we randomized 64 participants with a mean quantitative blood loss at time of intrauterine balloon tamponade placement of 2,133 mL, with 31 individuals placed in the 18-hour duration group and 33 placed in the 6-hour duration group. All received their assigned intervention; however, two participants were excluded due to protocol violation. Characteristics were similar between groups. The median (IQR) quantitative blood loss 18 hours after intrauterine balloon tamponade placement was 135.0 mL in the 18-hour group (81-184 mL) and 110.0 mL in the 6-hour group (60-172 mL) ( P <.001). Intrauterine balloon tamponade was successful in treating all randomized participants, with no difference in secondary outcomes between groups.
Conclusion:
Intrauterine balloon tamponade usage for 6 hours was noninferior to 18 hours of usage for mitigating blood loss after vaginal delivery PPH. It may be reasonable to remove an intrauterine balloon tamponade after 6 hours.
Clinical Trial Registration:
ClinicalTrials.gov, NCT04467996.
