Department of Obstetrics & Gynecology, Columbia University Irving Medical Center, New York, NY, USA.
Department of Obstetrics & Gynecology, Baylor College of Medicine, Houston, TX, USA.
Int Urogynecol J. 2024 Sep;35(9):1839-1849. doi: 10.1007/s00192-024-05881-6. Epub 2024 Aug 3.
The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery.
A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months.
A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related.
The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.
本研究旨在评估一种经阴道使用的机电式盆底扩张器在降低阴道分娩时会阴体肌（LAM）撕裂风险方面的安全性和有效性。
一项多中心、随机对照试验纳入了计划行阴道分娩的初产妇。在第一产程中，参与者被随机分配至接受阴道内设备或标准分娩管理。主要有效性终点是在产后 3 个月时经会阴盆底超声检查是否存在完全 LAM 撕裂。三位尿妇科医生对超声图像进行了盲法解读。主要安全性终点是产后 3 个月内的不良事件（AE）。
共 214 名女性被随机分配至设备组（n=113）或对照组（n=101）。在 113 名设备组中，82 名接受了设备放置，其中 68 名经阴道分娩。在 101 名对照组中，85 名经阴道分娩。在产后 3 个月时，110 名参与者（46 名接受了完整设备治疗的设备组参与者和 64 名对照组参与者）接受了超声检查。在设备组中，未发生完全 LAM 撕裂（0.0%），而对照组中有 7 例（10.9%）发生（p=0.040；双侧 Fisher 检验）。仅有 1 例母亲的严重 AE（撕裂伤）与设备相关；无新生儿严重 AE 与设备相关。
在经阴道分娩的初产妇中，盆底扩张器显著降低了完全性 LAM 撕裂的发生率。该扩张器具有可接受的安全性，且深受使用者欢迎。在分娩的初产妇中使用经阴道的机电式盆底扩张器可能会降低 LAM 撕裂的发生率，这种损伤与严重的后遗症（包括盆腔器官脱垂）有关。
