Effectiveness of the Intrauterine Balloon Tamponade Compared With an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device for Postpartum Hemorrhage.

Abstract

OBJECTIVE To compare intrauterine balloon tamponade and vacuum-induced hemorrhage-control devices in a multicenter hospital system using a standardized three-stage postpartum hemorrhage response algorithm. METHODS As part of a quality improvement project, data were prospectively collected through ongoing detailed hemorrhage case audits from 65 facilities from August 2022 to February 2024. Postpartum hemorrhage-control devices are recommended for stage 2 or 3 of the postpartum hemorrhage algorithm. The primary outcomes were 1) quantitative blood loss after device placement, 2) rate of packed red blood cell (RBC) transfusion, 3) use of 3 units of packed RBCs or more, and 4) device failure. RESULTS During the 17-month observation period, there were 123,292 deliveries, and postpartum hemorrhage occurred in 5,931 (4.8%). Postpartum hemorrhage-control devices were used in 11.2% of cases (666 total, intrauterine balloon tamponade n=300, and vacuum-induced hemorrhage control n=366). For intrauterine balloon tamponade and vacuum-induced hemorrhage-control devices, quantitative blood loss (median and interquartile range) after device placement was similar at 194 (67-440) mL and 240 (113-528) mL (P=.40), respectively, as was the rate of any packed RBC transfusion (59.7% vs 50.0%, P=.08), transfusion of 3 packed RBC units or more (27.0% vs 24.9%, P=.53), and device failure (7.7% vs 8.5%, P=.70). Placement of either device at a quantitative blood loss between 1,000 and 1,499 mL compared with 1,500 mL or more resulted in significantly lower rates of packed RBC transfusion (39.1% vs 70.3%, P<.001), transfusion of 3 or more packed RBC units (13.7 vs 38.1%, P<.001), and device failure (3.4% vs 12.9%, P<.001). CONCLUSION Transfusion and blood loss after device placement were similar with both hemorrhage-control devices. Earlier hemorrhage-control device placement reduced device failure and the need for transfusion.