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在第二产程中,直接开放式推挤法是否比直接闭合法更有效?一项实用随机试验——EOLE 研究。

Is directed open-glottis pushing more effective than directed closed-glottis pushing during the second stage of labor? A pragmatic randomized trial - the EOLE study.

机构信息

Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France.

Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France.

出版信息

Midwifery. 2020 Dec;91:102843. doi: 10.1016/j.midw.2020.102843. Epub 2020 Sep 22.

Abstract

OBJECTIVE

To compare the effectiveness of directed open-glottis and directed closed-glottis pushing.

DESIGN

Pragmatic, randomised, controlled, non-blinded superiority study.

SETTINGS

Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals).

PARTICIPANTS

250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group. The exclusion criteria were previous caesarean birth or fetal heart rate anomaly. Participants were randomised during labour, after a cervical dilation ≥ 7 cm.

INTERVENTIONS

In the intervention group, open-glottis pushing was defined as a prolonged exhalation contracting the abdominal muscles (pulling the stomach in) to help move the fetus down the birth canal. Closed-glottis pushing was defined as Valsalva pushing.

MEASUREMENTS

The principal outcome was "effectiveness of pushing" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion. The results in our intention-to-treat analysis are reported as crude relative risks (RR) with their 95% confidence intervals. A multivariable analysis was used to take the relevant prognostic and confounding factors into account and obtain an adjusted relative risk (aRR).

FINDINGS

In our intention-to-treat analysis, most characteristics were similar across groups including epidural analgesia (>95% in each group). The mean duration of the expulsion phase was longer among the open-glottis group (24.4 min ± 17.4 vs. 18.0 min ± 15.0, p=0.002). The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).

KEY CONCLUSIONS

In maternity units with a high rate of epidural analgesia, the effectiveness of the type of directed pushing does not appear to differ between the open- and closed-glottis groups.

IMPLICATIONS FOR PRACTICE

If directed pushing is necessary, women should be able to choose the type of directed pushing they prefer to use during birth. Professionals must therefore be trained in both types so that they can adequately support women as they give birth.

摘要

目的

比较定向开声门推挤法和定向闭声门推挤法的效果。

设计

实用、随机、对照、非盲优势研究。

地点

2015 年 7 月至 2017 年 6 月间法国的 4 家医院(2 家学术医院和 2 家综合医院)。

参与者

250 名接受过两种推挤方式标准化培训的产妇,单胎足月(≥37 周)头位,由助产士纳入并随机分组;每组 125 名。排除标准为既往剖宫产或胎儿心率异常。参与者在产程中,宫颈扩张≥7cm 后随机分组。

干预措施

干预组中,开声门推挤法定义为延长呼气,收缩腹肌(向内拉腹部)以帮助胎儿沿产道下降。闭声门推挤法定义为瓦氏推挤法。

测量

主要结局为“推挤效果”,定义为无会阴切开术、第二、三、四级会阴损伤的自然分娩。意向治疗分析的结果报告为粗相对风险(RR)及其 95%置信区间。多变量分析用于考虑相关预后和混杂因素,并获得调整后的相对风险(aRR)。

结果

在意向治疗分析中,两组的大多数特征相似,包括硬膜外镇痛(每组均超过 95%)。开声门组的娩出期平均时间较长(24.4 分钟±17.4 分钟比 18.0 分钟±15.0 分钟,p=0.002)。两组的推挤效果(开声门组 48.0%,闭声门组 55.2%,调整后相对风险(aRR)为 0.92,95%置信区间(CI)为 0.74-1.14)或器械分娩的风险(aRR 0.97,95%CI 0.85-1.10)似乎无差异。

主要结论

在硬膜外镇痛率较高的产科单位,开声门和闭声门推挤法的效果似乎没有差异。

临床意义

如果需要定向推挤,女性应该能够选择她们在分娩时喜欢使用的定向推挤法类型。因此,专业人员必须接受两种方法的培训,以便在女性分娩时能够充分支持她们。

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