Orejuela Francisco J, Gandhi Rajshi, Mack Lauren, Lee Wesley, Sangi-Haghpeykar Haleh, Dietz Hans P, Ramin Susan M
Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA.
Department of Obstetrics and Gynecology, Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
Int Urogynecol J. 2018 Oct;29(10):1485-1492. doi: 10.1007/s00192-018-3555-0. Epub 2018 Feb 6.
The objective was to assess the safety and feasibility of using a pelvic floor dilator during active labor to prevent injuries to the levator ani muscle (LAM) and perineum.
In a prospective pilot study, a pelvic floor dilator using soft pads was introduced into the vaginal canal to gradually expand the vagina, in 30 nulliparous women and in 10 controls. The primary outcomes were adverse events related to the device. Secondary outcomes were perineal lacerations after delivery, sonographically defined levator ani injury, hiatal area dimensions, and anal sphincter disruption, all at 12-20 weeks postpartum, and maximum pelvic floor dilation, time to achieve maximum dilation, and device retention rate.
From October 2014 through November 2016, a total of 494 women were screened, and 61 consented to the study. Thirty women used the device and 27 returned for follow-up. No maternal or neonatal injuries were related to use of the dilator. The average maximum dilation of the vaginal canal was 7.4 cm (SD 0.7, range 5.5-8.0). Dilation time averaged 27 min (SD 13, range 5-60). Device insertion adjustment was needed in 13 out of 30 cases (43%). Similar rates of 3th-4th degree perineal lacerations were seen in both groups. Levator ani avulsion was diagnosed in 2 out of 27 (7%) in the device group and in 1 out of 9 (11%) in the control group (p = 0.2). The rate of partial injury in the device group was 2 out of 27 (7%) vs 2 out of 9 (22%) in the comparison group (p = 0.2).
The use of the pelvic floor dilator during active labor is feasible. No safety issues were identified.
目的是评估在活跃期分娩时使用盆底扩张器预防肛提肌（LAM）和会阴损伤的安全性和可行性。
在一项前瞻性试点研究中，将使用软垫的盆底扩张器插入30例未产妇和10例对照组女性的阴道管内，以逐渐扩张阴道。主要结局是与该装置相关的不良事件。次要结局包括产后12 - 20周时的会阴裂伤、超声定义的肛提肌损伤、裂孔面积尺寸和肛门括约肌断裂，以及最大盆底扩张度、达到最大扩张度的时间和装置保留率。
从2014年10月至2016年11月，共筛查了494名女性，61名同意参加研究。30名女性使用了该装置，27名返回进行随访。未发现与扩张器使用相关的母婴损伤。阴道管的平均最大扩张度为7.4厘米（标准差0.7，范围5.5 - 8.0）。扩张时间平均为27分钟（标准差13，范围5 - 60）。30例中有13例（43%）需要进行装置插入调整。两组的3 - 4度会阴裂伤发生率相似。装置组27例中有2例（7%）诊断为肛提肌撕裂，对照组9例中有1例（11%）（p = 0.2）。装置组部分损伤率为27例中有2例（7%），而对照组为9例中有2例（22%）（p = 0.2）。
在活跃期分娩时使用盆底扩张器是可行的。未发现安全问题。
