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分娩时使用卷绕式胎儿多普勒仪与皮纳德听诊器进行胎儿心率间歇监测的随机临床试验。

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial.

作者信息

Byaruhanga R, Bassani D G, Jagau A, Muwanguzi P, Montgomery A L, Lawn J E

机构信息

Department of Obstetrics and Gynaecology, St. Raphael of St. Francis Hospital Nsambya, Kampala, Uganda.

Centre for Global Child Health, Hospital for Sick Children, Toronto, Canada.

出版信息

BMJ Open. 2015 Jan 30;5(1):e006867. doi: 10.1136/bmjopen-2014-006867.

Abstract

OBJECTIVES

In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes.

DESIGN

Prospective equally randomised clinical trial.

SETTING

The labour and delivery unit of a teaching hospital in Kampala, Uganda.

PARTICIPANTS

Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not.

INTERVENTION

Intermittent FHR monitoring using Doppler.

PRIMARY OUTCOME MEASURES

Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge.

RESULTS

Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34).

CONCLUSIONS

Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death.

TRIAL REGISTRATION NUMBER

Clinical Trails.gov (1000031587).

摘要

目的

在资源匮乏地区,用于指导产程管理的标准护理方法是使用产程图加皮纳德听诊器进行间歇性胎儿心率(FHR)监测。我们将一种新型、耐用的可卷绕手持式多普勒超声与皮纳德听诊器用于产程中的FHR监测进行比较,以作为围产期结局中FHR异常的主要筛查工具。

设计

前瞻性随机对照临床试验。

地点

乌干达坎帕拉一家教学医院的 labor and delivery unit(此处原文可能有误,推测为产房和分娩单元)。

参与者

在2042名符合条件的产前妇女中,1971名足月活跃期分娩的妇女,在经历无并发症的妊娠后,被随机分配接受或不接受标准护理。

干预措施

使用多普勒超声进行间歇性FHR监测。

主要结局指标

FHR异常检测的发生率以及分娩前的死产和新生儿死亡率。

结果

研究组之间的年龄、产次、孕周、分娩方式和新生儿体重相似。在多普勒超声组中,检测到的FHR异常率显著更高(发病率比(IRR)=1.61,95%可信区间1.13至2.30)。然而,在该组中,分娩时死产率(IRR=3.94,0.44至35.24)和新生儿死亡率(IRR=1.38,0.44至4.34)也较高,但无统计学意义。

结论

使用手持式多普勒超声进行常规监测可增加产程中FHR异常的识别;然而,我们的试验未发现证据表明这会导致分娩时死产或新生儿死亡发生率的降低。

试验注册号

Clinical Trails.gov(1000031587)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8e7/4316429/7497fc96e2f9/bmjopen2014006867f01.jpg

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