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手法旋转后持续性枕后位结局的随机对照研究。

Persistent occiput posterior position outcomes following manual rotation: a randomized controlled trial.

机构信息

Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Discipline of Obstetrics, Gynaecology and Neonatology, The University of Sydney, Sydney, New South Wales, Australia.

Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

出版信息

Am J Obstet Gynecol MFM. 2021 Mar;3(2):100306. doi: 10.1016/j.ajogmf.2021.100306. Epub 2021 Jan 6.

Abstract

BACKGROUND

Persistent occiput posterior position in labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation from the occiput posterior position to the occiput anterior position in the second stage of labor is considered a safe and easy to perform procedure that in observational studies has shown promise as a method for preventing operative deliveries.

OBJECTIVE

This study aimed to determine the efficacy of prophylactic manual rotation in the management of occiput posterior position for preventing operative delivery. The hypothesis was that among women who are at least 37 weeks pregnant and whose baby is in the occiput posterior position early in the second stage of labor, manual rotation will reduce the rate of operative delivery compared with the "sham" rotation.

STUDY DESIGN

A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 4 tertiary hospitals was conducted in Australia. A total of 254 nulliparous and parous women with a term pregnancy and a baby in the occiput posterior position in the second stage of labor were randomly assigned to receive either a prophylactic manual rotation (n=127) or a sham rotation (n=127). The primary outcome was operative delivery (cesarean, forceps, or vacuum delivery). Secondary outcomes were cesarean delivery, combined maternal mortality and serious morbidity, and combined perinatal mortality and serious morbidity. Analysis was by intention to treat. Proportions were compared using chi-square tests adjusted for stratification variables using the Mantel-Haenszel method or the Fisher exact test. Planned subgroup analyses by operator experience and by manual rotation technique (digital or whole-hand rotation) were performed.

RESULTS

Operative delivery occurred in 79 of 127 women (62%) assigned to prophylactic manual rotation and 90 of 127 women (71%) assigned to sham rotation (common risk difference, 12; 95% confidence interval, -1.7 to 26; P=.09). Among more experienced operators or investigators, operative delivery occurred in 46 of 74 women (62%) assigned to manual rotation and 52 of 71 women (73%) assigned to a sham rotation (common risk difference, 18; 95% confidence interval, -0.5 to 36; P=.07). Cesarean delivery occurred in 22 of 127 women (17%) in both groups. Instrumental delivery (forceps or vacuum) occurred in 57 of 127 women (45%) assigned to prophylactic manual rotation and 68 of 127 women (54%) assigned to sham rotation (common risk difference, 10; 95% confidence interval, -3.1 to 22; P=.14). There was no significant difference in the combined maternal and perinatal outcomes.

CONCLUSION

Prophylactic manual rotation did not result in a reduction in the rate of operative delivery. Given manual rotation was associated with a nonsignificant reduction in operative delivery, more randomized trials are needed, as our trial might have been underpowered. In addition, further research is required to further explore the potential impact of operator or investigator experience.

摘要

背景

分娩时持续性枕后位与不良的母婴围产结局相关。在第二产程中预防性地将胎方位从枕后位转为枕前位被认为是一种安全且易于操作的方法,观察性研究表明其具有预防剖宫产的潜力。

目的

本研究旨在确定预防性手法旋转在管理枕后位以预防剖宫产中的效果。假设在至少 37 孕周且胎儿处于第二产程中枕后位的孕妇中,与“假旋转”相比,手法旋转将降低剖宫产率。

研究设计

这是在澳大利亚 4 家三级医院进行的一项双盲、平行、优效性、多中心、随机对照临床试验。共有 254 名初产妇和经产妇在第二产程中胎儿为枕后位,被随机分为接受预防性手法旋转(n=127)或假旋转(n=127)。主要结局是剖宫产(产钳、真空吸引或剖宫产)。次要结局是剖宫产、产妇合并严重发病率和死亡率、围产儿合并严重发病率和死亡率。采用意向治疗进行分析。采用卡方检验比较比例,采用 Mantel-Haenszel 法或 Fisher 确切概率法对分层变量进行校正。进行了按操作者经验和手法旋转技术(手指或全手旋转)的计划亚组分析。

结果

在接受预防性手法旋转的 127 名女性中,79 名(62%)发生了剖宫产,在接受假旋转的 127 名女性中,90 名(71%)发生了剖宫产(共同风险差异,12;95%置信区间,-1.7 至 26;P=.09)。在经验更丰富的操作者或研究者中,在接受手法旋转的 74 名女性中,46 名(62%)发生了剖宫产,在接受假旋转的 71 名女性中,52 名(73%)发生了剖宫产(共同风险差异,18;95%置信区间,-0.5 至 36;P=.07)。两组均有 22 名女性行剖宫产。在接受预防性手法旋转的 127 名女性中,57 名(45%)行器械助产(产钳或真空吸引),在接受假旋转的 127 名女性中,68 名(54%)行器械助产(共同风险差异,10;95%置信区间,-3.1 至 22;P=.14)。产妇和围产儿的综合结局无显著差异。

结论

预防性手法旋转并未降低剖宫产率。由于手法旋转与剖宫产率的降低无关,需要进行更多的随机试验,因为我们的试验可能没有足够的效力。此外,需要进一步研究以进一步探索操作者或研究者经验的潜在影响。

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