Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel.
The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Int Urogynecol J. 2020 Nov;31(11):2377-2385. doi: 10.1007/s00192-020-04332-2. Epub 2020 May 24.
The objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears.
In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into "avoidance of episiotomy" (the study group in which episiotomy was allowed only in cases of fetal distress) or "standard care." The primary outcome was the incidence of advanced (3rd- and 4th-degree) perineal tears.
The participants were randomized into "standard care" (n = 337) vs. "no episiotomy" (n = 339) groups, not differing in any demographic or obstetric characteristics. Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004). Five (1.5%) advanced tears were diagnosed in the study group vs. ten = 3.0% in the controls, yielding an odds ratio of 0.50 (95% CI 0.17-1.50) in favor of the "no episiotomy" group (p = 0.296). No differences were noted in any secondary outcomes. By per protocol analysis (omitting cases in which episiotomy was performed for indications other than fetal distress in the study group), a trend to decreased risk of advanced tears in the study group was noted (p = 0.0956). By per protocol analyses, no severe tears were noted in the 53 vacuum deliveries in the study group vs. 4/65 (6.2%) tears in the controls (p = 0.126).
Since decreased use of episiotomy was not associated with higher rates of severe tears or any other adverse outcomes, we believe this procedure can be avoided in spontaneous as well as vacuum-assisted deliveries. Trial registration no. NCT02356237.
本试验的目的是评估避免会阴切开术是否可以降低严重会阴撕裂的风险。
在这项随机（1:1）平行组优效性试验中，初产妇被随机分为“避免会阴切开术”（研究组，仅在胎儿窘迫的情况下允许会阴切开术）或“标准护理”。主要结局是先进（3 度和 4 度）会阴撕裂的发生率。
参与者被随机分为“标准护理”（n=337）与“无会阴切开术”（n=339）组，两组在任何人口统计学或产科特征上均无差异。研究组的会阴切开率明显低于标准护理组（19.6% vs. 29.8%，p=0.004）。研究组有 5 例（1.5%）发生先进撕裂，对照组有 10 例（3.0%），研究组的比值比为 0.50（95%CI 0.17-1.50）（p=0.296）。在任何次要结局方面均无差异。通过方案分析（排除研究组中因胎儿窘迫以外的指征进行会阴切开术的病例），研究组发生先进撕裂的风险呈下降趋势（p=0.0956）。通过方案分析，研究组 53 例真空分娩中未发生严重撕裂，对照组 65 例中有 4 例（6.2%）撕裂（p=0.126）。
由于会阴切开术的使用减少与严重撕裂或任何其他不良结局无关，我们认为，在自然分娩和真空辅助分娩中均可避免该手术。试验注册号：NCT02356237。
