Department of Obstetrics and Gynecology, Columbia University, New York, NY.
Department of Obstetrics and Gynecology, Columbia University, New York, NY.
Am J Obstet Gynecol. 2024 Mar;230(3S):S1076-S1088. doi: 10.1016/j.ajog.2023.08.015. Epub 2023 Aug 30.
Obstetrical hemorrhage is a relatively frequent obstetrical complication and a common cause of maternal morbidity and mortality worldwide. The majority of maternal deaths attributable to hemorrhage are preventable, thus, developing rapid and effective means of treating postpartum hemorrhage is of critical public health importance. Intrauterine devices are one option for managing refractory hemorrhage, with rapid expansion of available devices in recent years. Intrauterine packing was historically used for this purpose, with historical cohorts documenting high rates of success. Modern packing materials, including chitosan-covered gauze, have recently been explored with success rates comparable to uterine balloon tamponade in small trials. There are a variety of balloon tamponade devices, both commercial and improvised, available for use. Efficacy of 85.9% was cited in a recent meta-analysis in resolution of hemorrhage with the use of uterine balloon devices, with greatest success in the setting of atony. However, recent randomized trials have demonstrated potential harm associated with improvised balloon tamponade use In low resource settings and the World Health Organization recommends use be restricted to settings where monitoring is available and care escalation is possible. Recently, intrauterine vacuum devices have been introduced, which offer a new mechanism for achieving hemorrhage control by mechanically restoring uterine tone via vacuum suction. The Jada device, which is is FDA-cleared and commercially available in the US, found successful bleeding control in 94% of cases in an initial single-arm trial, with recent post marketing registry study described treatment success following hemorrhage in 95.8% of vaginal and 88.2% of cesarean births. Successful use of improvised vacuum devices has been described in several studies, including suction tube uterine tamponade via Levin tubing, and use of a modified Bakri balloon. Further research is needed with head-to-head comparisons of efficacy of devices and assessment of cost within the context of both device pricing and overall healthcare resource utilization.
产科出血是一种较为常见的产科并发症，也是全球范围内导致产妇发病率和死亡率的常见原因。大多数可归因于出血的产妇死亡是可以预防的，因此，开发快速有效的产后出血治疗方法具有重要的公共卫生意义。宫内节育器是治疗难治性出血的一种选择，近年来可用的器械迅速增加。宫内填塞曾用于此目的，历史队列记录了其成功率较高。最近，包括壳聚糖覆盖纱布在内的现代填塞材料已被成功探索，其成功率在小范围试验中与子宫球囊压迫相当。有各种球囊压迫装置，包括商业和临时的，可用于使用。最近的一项荟萃分析表明，使用子宫球囊装置可使 85.9%的出血得到缓解，在宫缩乏力的情况下效果最佳。然而，最近的随机试验表明，在资源有限的环境中，临时球囊压迫使用可能存在潜在危害，世界卫生组织建议将其限制在可以进行监测和可以升级护理的环境中。最近，宫内真空装置已经推出，它通过真空吸力机械恢复子宫张力，为实现出血控制提供了一种新的机制。Jada 装置已获得美国食品和药物管理局的批准，并可在美国商业使用，在最初的一项单臂试验中，94%的病例成功控制了出血，最近的一项上市后注册研究报告了 95.8%阴道分娩和 88.2%剖宫产出血后的治疗成功。在几项研究中，包括通过 Levin 管进行吸管子宫填塞和使用改良 Bakri 球囊，都成功使用了临时真空装置。需要进一步研究，对头对头比较器械的疗效，并在器械定价和整体医疗资源利用的背景下评估成本。
