Sagi-Dain Lena, Bahous Rabia, Caspin Orna, Kreinin-Bleicher Inna, Gonen Ron, Sagi Shlomi
Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel.
Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel.
Int Urogynecol J. 2018 Mar;29(3):415-423. doi: 10.1007/s00192-017-3480-7. Epub 2017 Sep 20.
The objective of this trial was to evaluate whether avoiding episiotomy can decrease the risk of advanced perineal tears.
In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into standard care (155 cases) vs. no episiotomy (154 cases) groups. The primary endpoint was the incidence of advanced (3rd- and 4th-degree) perineal tears. Secondary outcomes included perineal integrity, suturing characteristics, second-stage duration, incidence of postpartum hemorrhage, neonatal variables, and various postpartum symptoms 2 days and 2 months after delivery.
At prespecified 1-year interim analysis, the groups did not differ in terms of baseline demographic and obstetric characteristics. Six advanced perineal tears (3.9%) were diagnosed in the standard care group vs. two in no episiotomy group (1.3%), yielding a calculated odds ratio (OR) of 0.33 [95% confidence interval (CI) 0.06-1.65). Unexpectedly, rates of episiotomy performance also did not significantly vary between groups: 26.5% (41 cases) vs. 21.4% (33 cases), respectively, p = 0.35. No significant differences were noted in any secondary outcomes.
No difference in the rates of advanced perineal tears was found between groups; however, the main limitation of our study was unexpectedly high rates of episiotomy in the nonepisiotomy group. Thus, the main conclusion is that investigator monitoring and education should be continuously practiced throughout the trial duration, stressing the importance of adherence to the protocol.
本试验的目的是评估避免会阴切开术是否可降低严重会阴裂伤的风险。
在这项随机（1:1）平行组优效性试验中，初产妇被随机分为标准护理组（155例）和无会阴切开术组（154例）。主要终点是严重（三度和四度）会阴裂伤的发生率。次要结局包括会阴完整性、缝合特点、第二产程时长、产后出血发生率、新生儿变量以及产后2天和2个月时的各种产后症状。
在预先设定的1年中期分析中，两组在基线人口统计学和产科特征方面无差异。标准护理组诊断出6例严重会阴裂伤（3.9%），无会阴切开术组为2例（1.3%），计算得出的优势比（OR）为0.33[95%置信区间（CI）0.06 - 1.65]。出乎意料的是，两组间会阴切开术的实施率也无显著差异：分别为26.5%（41例）和21.4%（33例），p = 0.35。在任何次要结局方面均未发现显著差异。
两组间严重会阴裂伤发生率无差异；然而，本研究的主要局限性是无会阴切开术组的会阴切开术发生率意外地高。因此，主要结论是在整个试验期间应持续进行研究者监督和教育，强调遵守方案的重要性。
