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随机对照试验:在资源匮乏环境下,连续多普勒与间歇性胎儿镜胎儿心率监测的比较。

Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting.

机构信息

Haydom Lutheran Hospital, Mbulu, Tanzania.

Department of Health Science, University of Stavanger, Stavanger, Norway.

出版信息

Int J Gynaecol Obstet. 2018 Dec;143(3):344-350. doi: 10.1002/ijgo.12648. Epub 2018 Sep 4.

Abstract

OBJECTIVE

To compare the frequency of abnormal fetal heart rate (FHR) detection between continuous Doppler and intermittent fetoscope monitoring.

METHOD

A randomized controlled open-label trial was conducted between February 1, 2016, and January 31, 2017, at Haydom Lutheran hospital, Tanzania. Women in active labor with singleton pregnancies and normal FHR at admission were randomly allocated in a 1:1 ratio to receive either continuous or intermittent FHR monitoring. The primary outcome was abnormal FHR detection.

RESULTS

2652 women were enrolled; 1340 received continuous monitoring and 1312 received intermittent monitoring. Continuous FHR monitoring detected abnormal FHR in 108 (8.1%) participants versus 40 (3.0%) participants in the intermittent monitoring group (risk ratio [RR] 2.64, 95% confidence interval [CI] 1.8-3.7; P<0.001). The increased detection rate in the continuous versus intermittent monitoring group was associated with an increase in rate of subsequent intrauterine resuscitations (89 [6.6%] vs 42 [3.2%]; RR 2.07, 95% CI 1.4-2.9; P<0.001). In total, 92 (3.5%) infants had adverse perinatal outcomes, with no significant differences between groups.

CONCLUSION

Continuous FHR monitoring increased identification of abnormal FHR and subsequent intrauterine resuscitations. ClinicalTrials.gov: NCT02790814.

摘要

目的

比较连续多普勒和间断胎儿监护仪监测胎儿心率异常的频率。

方法

这是一项于 2016 年 2 月 1 日至 2017 年 1 月 31 日在坦桑尼亚海顿路德教会医院进行的随机对照、开放标签试验。纳入具有单胎妊娠且入院时胎心率正常的活跃产妇,按 1:1 比例随机分配至连续或间断胎心率监测。主要结局为异常胎心率检测。

结果

共纳入 2652 例产妇,1340 例接受连续监测,1312 例接受间断监测。连续胎心率监测组有 108 例(8.1%)参与者检测到异常胎心率,而间断监测组有 40 例(3.0%)(风险比 [RR] 2.64,95%置信区间 [CI] 1.8-3.7;P<0.001)。与间断监测组相比,连续监测组的异常胎心率检测率增加与随后宫内复苏率增加相关(89 例[6.6%] vs 42 例[3.2%];RR 2.07,95% CI 1.4-2.9;P<0.001)。共有 92 例(3.5%)婴儿出现不良围产结局,但组间无显著差异。

结论

连续胎心率监测增加了异常胎心率的检出率,并增加了随后的宫内复苏。

临床试验注册

NCT02790814。

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