Department of Obstetrics and Gynecology and the Center for Regenerative Medicine, Oregon Health & Sciences University, Portland, and OBSTETRX, Inc., Wilsonville, Oregon; the Department of Obstetrics and Gynecology, University of Zambia School of Medicine, Lusaka, Zambia; and Intellectual Ventures Laboratory, Seattle, Washington.
Obstet Gynecol. 2020 Nov;136(5):876-881. doi: 10.1097/AOG.0000000000004135.
Postpartum hemorrhage is a leading cause of maternal mortality globally. A tamponade agent that can be quickly and easily placed in a range of settings could advance the treatment of atonic hemorrhage.
We adapted a highly effective trauma dressing for use in postpartum hemorrhage. This mini-sponge tamponade device is comprised of two components: compressed mini-sponges contained within a strong mesh pouch and a tubular applicator. Compressed mini-sponges rapidly absorb blood, expand within seconds, and exert sustained pressure uniformly to bleeding sites. The sponges are deployed within a mesh pouch to facilitate simple vaginal removal.
We successfully placed the mini-sponge device in nine patients experiencing postpartum hemorrhage after vaginal birth, with resolution of bleeding within 1 minute. The mean time to place the device was 62 seconds. Uterine fill was documented in all cases by ultrasound scan, and device placement was rated as "easy" to "very easy." Mini-sponges were left in place on average for 1 hour (0.5 hours-14 hours). Bleeding did not recur. There were no adverse events; all patients remained afebrile and did not require subsequent surgical intervention.
This study supports further evaluation of the mini-sponge device for the management of postpartum hemorrhage.
This study was funded by OBSTETRX, Inc.
产后出血是全球范围内导致产妇死亡的主要原因。一种能够在多种环境中快速简便放置的止血剂可以推进对宫缩乏力性出血的治疗。
我们对一种高效的创伤敷料进行了改良，用于产后出血的治疗。这种迷你海绵填塞装置由两部分组成：压缩迷你海绵，装在一个坚固的网袋内，以及一个管状给药器。压缩迷你海绵迅速吸收血液，在数秒内膨胀，并均匀地对出血部位施加持续的压力。海绵装在网袋内，便于阴道内简单取出。
我们成功地将迷你海绵装置用于 9 名经历阴道分娩后产后出血的患者，出血在 1 分钟内得到控制。放置装置的平均时间为 62 秒。所有病例均通过超声扫描记录子宫充盈情况，装置放置的评级为“容易”到“非常容易”。迷你海绵的平均留置时间为 1 小时（0.5 小时至 14 小时）。未再发生出血。无不良事件发生；所有患者均未发热，也无需后续手术干预。
这项研究支持进一步评估迷你海绵装置在产后出血管理中的应用。
本研究由 OBSTETRX， Inc. 提供资金支持。
