目的:评估会阴侧切的效果,与没有会阴切开术相比,关于需要真空拔除的未产妇女的产科肛门括约肌损伤。
方法:多中心,开放标签,随机对照试验。
方法:瑞典八家医院,2017-23。
方法:717名单胎活胎34孕周或以上的未产妇女,使用密封的不透明包膜,将需要真空摘除术的患者随机分配(1:1)至会阴侧切术或不进行会阴侧切术.随机化按研究地点分层。
方法:在真空拔除过程中进行标准化的会阴侧切,在胎儿头部加冕时,从后部Fourchette开始1-3厘米,与中线成60°(45-80°)角,和4厘米(3-5厘米)长。除非认为必不可少,否则比较没有会阴切开术。
方法:在真空辅助分娩(EVA)试验中进行会阴切开术的主要结果是产科肛门括约肌损伤,通过联合目视检查和直肠和阴道指检进行临床诊断。主要分析使用了改良的意向治疗人群,其中包括所有同意尝试或成功抽真空的妇女。作为显著性水平P<0.01的中期分析的结果,在4%显著性水平下测试主要终点,伴随96%置信区间(CI)。
结果:从2017年7月1日至2023年2月15日,717名妇女被随机分配:354名(49%)进行会阴侧切,363名(51%)没有进行会阴侧切。在尝试抽真空之前,一名妇女撤回同意,14名妇女自然分娩,留下702进行初步分析。在干预组中,21(6%)的344名妇女持续产科肛门括约肌损伤,与对照组358名女性中的47名(13%)相比(P=0.002)。风险差异为-7.0%(96%CI-11.7%至-2.5%)。调整后的风险比为0.47(96%CI0.23至0.97),未调整的风险比为0.46(0.28至0.78)。两组产后疼痛无显著差异,失血,新生儿结局,或总不良事件,但干预组有更多的伤口感染和裂开。
结论:对于需要真空摘除术的未产妇,可以推荐会阴侧切,以显著降低产科肛门括约肌损伤的风险。
背景:ClinicalTrials.govNCT02643108。
To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction.
A multicentre, open label, randomised controlled
trial.
Eight hospitals in Sweden, 2017-23.
717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by
study site.
A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable.
The primary outcome of the episiotomy in vacuum assisted delivery (EVA)
trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI).
From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was -7.0% (96% CI -11.7% to -2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence.
Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury.
ClinicalTrials.gov NCT02643108.