NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York; The Ohio State University, Columbus, Ohio; University of Utah Health, Salt Lake City, Utah; the University of Pittsburgh Medical Center-Magee Women's Hospital, Pittsburgh, Pennsylvania; NewYork-Presbyterian/Queens, Flushing, New York; the University of Alabama, UAB Center for Women's Reproductive Health, Birmingham, Alabama; MetroHealth Medical Center, Cleveland, Ohio; Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey; the University of Texas Medical Branch at Galveston, Galveston, Texas; the University of Virginia, Charlottesville, Virginia; MedStar Washington Hospital Center, Washington, DC; Geisinger Medical Center, Danville, Pennsylvania; Massachusetts General Hospital, Boston, Massachusetts; the Cleveland Clinic, Cleveland, Ohio; Oregon Health & Science University, Portland, Oregon; Alydia Health, Menlo Park, California; McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas; Northwestern University/Northwestern Memorial Hospital, Chicago, Illinois; and the Indiana University School of Medicine, Indianapolis, Indiana.
Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.
To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.
A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device.
Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%).
Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality.
Alydia Health, Inc.
ClinicalTrials.gov, NCT02883673.
评估一种宫腔内真空诱导出血控制装置治疗产后出血的效果和安全性。
在美国 12 家中心开展了一项多中心、前瞻性、单臂治疗研究，该研究评估了一种新型宫腔内装置，该装置使用低水平真空诱导子宫平滑肌收缩，以控制异常产后子宫出血和产后出血。主要有效性终点是使用宫腔内真空诱导出血控制装置控制异常出血而无需升级干预的参与者比例。主要安全性终点是与器械相关的不良事件的发生率、严重程度和严重程度。次要结局包括出血控制时间、输血率和每位研究者使用器械的可用性评分。
在 107 名患有原发性产后出血或异常产后子宫出血的参与者中，有 106 名接受了任何与该设备相关的研究治疗，其中 94%（100/106，95%CI 88-98%）的参与者观察到成功治疗。在这 100 名参与者中，连接真空后，异常出血的明确控制中位数为 3 分钟（四分位间距 2.0-5.0）。报告了 8 例不良事件，认为可能与设备或手术过程相关，所有这些都在研究中列为风险，所有这些都通过治疗解决，没有严重的临床后遗症。35 名参与者需要输注 1-3 单位的红细胞，5 名参与者需要输注 4 个或更多单位的红细胞。大多数研究者报告宫腔内真空诱导出血控制装置易于使用（98%），并会推荐使用（97%）。
宫腔内真空诱导出血控制可能为异常产后子宫出血或产后出血提供一种新的快速有效治疗选择，有可能预防严重的产妇发病率和死亡率。
Alydia Health，Inc.
ClinicalTrials.gov，NCT02883673。
