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.

中文翻译：

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宫内球囊填塞与宫内真空诱导出血控制装置相比对产后出血的有效性。


目的 使用标准化的三阶段产后出血反应算法，比较多中心医院系统中的宫内球囊填塞和真空诱导出血控制装置。方法 作为质量改进项目的一部分，通过 2022 年 8 月至 2024 年 2 月期间从 65 个设施进行的详细出血病例审计前瞻性收集数据。建议将产后出血控制装置用于产后出血流程的第 2 期或第 3 期。主要结局是 1） 设备放置后的定量失血量，2） 浓缩红细胞 （RBC） 输注率，3） 使用 3 个单位或更多浓缩红细胞，以及 4） 设备失败。结果 在 17 个月的观察期内，有 123,292 例分娩，产后出血发生 5,931 例 （4.8%）。11.2% 的病例使用了产后出血控制装置 （总共 666 例，宫内球囊填塞 n=300，真空诱导出血控制 n=366）。对于宫内球囊填塞和真空诱导出血控制装置，装置放置后的定量失血量（中位数和四分位数范围）相似，分别为 194 （67-440） mL 和 240 （113-528） mL （P=.40），任何浓缩红细胞输注率 （59.7% vs 50.0%，P=.08），输注 3 个浓缩红细胞单位或更多 （27.0% vs 24.9%， P=.53） 和设备故障 （7.7% 对 8.5%，P=.70）。与 1,500 mL 或更多相比，将任一装置定量失血量置于 1,000 至 1,499 mL 之间，导致浓缩红细胞输注率显著降低 （39.1% vs 70.3%，P<.001），输注 3 个或更多浓缩红细胞单位 （13.7 vs 38.1%，P<.001） 和设备故障 （3.4% vs 12.9%，P<.001）。 结论 两种出血控制装置放置后的输血和失血量相似。早期放置出血控制装置减少了装置故障和输血需求。