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经腹经会阴超声与常规护理在器械性阴道分娩前的比较:一项随机对照试验。

Transabdominal and transperineal ultrasound vs routine care before instrumental vaginal delivery - A randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, Santa Maria University Hospital, Lisbon, Portugal.

Department of Obstetrics, Dr Alfredo da Costa Maternity Hospital, Lisbon, Portugal.

出版信息

Acta Obstet Gynecol Scand. 2021 Jun;100(6):1075-1081. doi: 10.1111/aogs.14065. Epub 2021 Jan 12.

DOI:10.1111/aogs.14065
PMID:33319355
Abstract

INTRODUCTION

The role of intrapartum ultrasound as an ancillary method to instrumental vaginal delivery is yet to be determined. This study aimed to compare the use of transabdominal and transperineal ultrasound with routine clinical care before performing an instrumental vaginal delivery, regarding the incidence of adverse maternal and neonatal outcomes.

MATERIAL AND METHODS

A randomized controlled trial was conducted between October 2016 and March 2019 in two tertiary care maternity hospitals in Lisbon, Portugal. Women at term, with full cervical dilatation, singleton fetuses in cephalic presentation, and with an established indication for instrumental vaginal delivery, were approached for enrollment. After informed consent was obtained, randomization into one of two groups was carried out. In the experimental arm, women underwent transabdominal ultrasound for determination of the fetal head position and transperineal ultrasound for evaluation of the angle of progression, before instrumental vaginal delivery. In the control arm, no ultrasound was carried out before instrumental vaginal delivery. Primary outcomes were composite measures of maternal and neonatal morbidity. Composite maternal morbidity consisted of severe postpartum hemorrhage, perineal trauma, and prolonged hospital stay. Composite neonatal morbidity consisted of low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma, and neonatal intensive care unit admission.

RESULTS

A total of 222 women were enrolled (113 in the experimental arm and 109 in the control arm). No significant differences between the two arms were found in composite measures of maternal (23.9% in the experimental group vs 22.9% in the control group, odds ratio 1.055, 95% CI 0.567-1.964) or neonatal morbidity (9.7% in the experimental group vs 6.4% in the control group, odds ratio 1.571, 95% CI 0.586-4.215), nor in any of the individual outcomes.

CONCLUSIONS

In this small randomized controlled trial that was stopped for futility before reaching the required sample size, transabdominal and transperineal ultrasound performed just before instrumental vaginal delivery did not reduce the incidence of adverse maternal and neonatal outcomes, when compared with routine clinical care.

摘要

简介

产时超声作为器械性阴道分娩的辅助方法的作用尚待确定。本研究旨在比较经腹超声和经会阴超声与常规临床护理在进行器械性阴道分娩前的应用,以评估不良母婴结局的发生率。

材料与方法

这是一项于 2016 年 10 月至 2019 年 3 月在葡萄牙里斯本的两家三级保健产科医院进行的随机对照试验。纳入足月、宫颈完全扩张、头位单胎且有器械性阴道分娩指征的妇女。在获得知情同意后,将其随机分为两组。实验组的妇女在行器械性阴道分娩前接受经腹超声以确定胎头位置,经会阴超声以评估进展角度。对照组则在行器械性阴道分娩前不进行超声检查。主要结局是母婴复合发病率的指标。复合产妇发病率包括严重产后出血、会阴创伤和住院时间延长。复合新生儿发病率包括低 5 分钟 Apgar 评分、脐动脉代谢性酸中毒、分娩创伤和新生儿重症监护病房入院。

结果

共纳入 222 名妇女(实验组 113 名,对照组 109 名)。两组间的母婴复合发病率指标(实验组 23.9%,对照组 22.9%,比值比 1.055,95%可信区间 0.567-1.964)或新生儿发病率指标(实验组 9.7%,对照组 6.4%,比值比 1.571,95%可信区间 0.586-4.215)均无显著差异,也无任何单一结局的差异。

结论

在这项小型随机对照试验中,由于在达到所需样本量之前就已达到无效性终点而提前停止,与常规临床护理相比,在器械性阴道分娩前进行经腹和经会阴超声检查并未降低不良母婴结局的发生率。

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