Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Kuala Lumpur, Malaysia.
BJOG. 2016 May;123(6):995-1003. doi: 10.1111/1471-0528.13924. Epub 2016 Feb 29.
Vaginal childbirth may result in levator ani injury secondary to overdistension during the second stage of labour. Other injuries include perineal and anal sphincter tears. Antepartum use of a birth trainer may prevent such injuries by altering the biomechanical properties of the pelvic floor. This study evaluates the effects of Epi-No(®) use on intrapartum pelvic floor trauma.
Multicentre prospective randomised controlled trial.
Two tertiary obstetric units in Australia.
Nulliparous women carrying an uncomplicated singleton term pregnancy.
Participants were assessed clinically and with 4D translabial ultrasound in the late third trimester, and again at 3-6 months postpartum. Women randomised to the intervention group were asked to use the Epi-No(®) device from 37 weeks of gestation until delivery.
Levator ani, anal sphincter, and perineal trauma diagnosed clinically and/or with translabial ultrasound imaging.
Of 660 women randomised, 504 (76.4%) returned for assessment at a mean of 5 months postpartum. There was no significant difference in the incidence of levator avulsion [12 versus 15%; relative risk (RR) 0.82, 95% confidence interval (95% CI) 0.51-1.32; absolute risk reduction (ARR) 0.03, 95% CI -0.04 to 0.09; P = 0.39], irreversible hiatal overdistension (13 versus 15%; RR 0.86, 95% CI 0.52-1.42; ARR 0.02, 95% CI -0.05 to 0.09; P = 0.51), clinical anal sphincter trauma (7 versus 6%; RR 1.12, 95% CI 0.49-2.60; ARR -0.01, 95% CI -0.05 to 0.06; P = 0.77), and perineal tears (51 versus 53%; RR 0.96, 95% CI 0.78-1.17; ARR 0.02, 95% CI -0.08 to 0.13; P = 0.65). A marginally higher rate of significant defects of the external anal sphincter on ultrasound was observed in the intervention group (21 versus 14%; RR 1.44, 95% CI 0.97-2.20; ARR -0.06, 95% CI -0.13 to 0.05; P = 0.07).
Antenatal use of the Epi-No(®) device is unlikely to be clinically beneficial in the prevention of intrapartum levator ani damage, or anal sphincter and perineal trauma.
No evidence of a protective effect of the Epi-No(®) device on intrapartum pelvic floor rauma.
阴道分娩可能导致第二产程中会阴过度扩张导致的会阴肌肉损伤。其他损伤包括会阴和肛门括约肌撕裂。产前使用分娩训练器可以通过改变盆底的生物力学特性来预防这些损伤。本研究评估了 Epi-No®使用对分娩时盆底创伤的影响。
多中心前瞻性随机对照试验。
澳大利亚的两个三级产科单位。
初产妇，单胎足月妊娠，无并发症。
参与者在妊娠晚期（第 3 期）和产后 3-6 个月进行临床和 4D 经会阴超声评估。随机分配到干预组的妇女被要求从 37 周妊娠开始使用 Epi-No®设备直到分娩。
临床和经会阴超声诊断的会阴肌肉、肛门括约肌和会阴损伤。
在 660 名随机分配的妇女中，504 名（76.4%）在产后平均 5 个月时进行了评估。会阴撕裂的发生率无显著差异[12%与 15%；相对风险（RR）0.82，95%置信区间（95%CI）0.51-1.32；绝对风险降低（ARR）0.03，95%CI -0.04 至 0.09；P = 0.39]，不可逆转的会阴裂孔过度扩张（13%与 15%；RR 0.86，95%CI 0.52-1.42；ARR 0.02，95%CI -0.05 至 0.09；P = 0.51）、临床肛门括约肌损伤（7%与 6%；RR 1.12，95%CI 0.49-2.60；ARR -0.01，95%CI -0.05 至 0.06；P = 0.77）和会阴撕裂（51%与 53%；RR 0.96，95%CI 0.78-1.17；ARR 0.02，95%CI -0.08 至 0.13；P = 0.65）。干预组超声检查发现外肛门括约肌显著缺陷的发生率略高（21%与 14%；RR 1.44，95%CI 0.97-2.20；ARR -0.06，95%CI -0.13 至 0.05；P = 0.07）。
产前使用 Epi-No®设备不太可能对预防分娩时会阴肌肉损伤或肛门括约肌和会阴损伤具有临床益处。
没有证据表明 Epi-No®设备对分娩时盆底损伤有保护作用。
