本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02228-6

摘要内容如下：

背景

脑胎盘比率与围产期死亡率和发病率相关，但常规测量是否能改善妊娠结局尚不清楚。我们的目的是评估与单独的生长评估相比，在近期标准超声生长评估中增加脑胎盘比率测量是否能降低围产期死亡率和严重新生儿发病率。

方法

Ratio37是一项随机、开放标签、多中心、实用的试验，在低风险孕妇中进行，从6个国家的9家医院招募。资格标准设计得很宽泛；参与者必须年满18岁，在妊娠前三个月经超声检查证实为单胎妊娠，在妊娠中期常规超声检查中胎儿存活且无先天性畸形，无不良病史或产科病史，并有能力给予知情同意。使用基于网络的系统，将妇女以1:1的比例（块大小100）随机分配到隐藏组或暴露组。在显示组中，临床医生已知脑胎盘比值，如果低于第5个百分位数，则建议在37周后计划分娩。在隐匿组中，女性和临床医生对脑胎盘比值不知情。所有参与者在妊娠36+0至37+6周时接受超声检查，并进行生长评估和多普勒评估。在两组中，当估计的胎儿体重低于第10百分位时，建议计划分娩。主要转归是从妊娠24周到婴儿出院的围产儿死亡率。该研究已在ClinicalTrials.gov（NCT02907242）上注册，现已结束。

调查结果

在2016年7月29日至2021年8月3日期间，我们招募了11214名女性，其中9492名（84.6%）完成了试验并符合分析条件（隐藏组4774名，揭露组4718名）。隐匿组4774例妊娠中有13例（0.3%）发生围产儿死亡，而隐匿组4718例妊娠中有13例（0.3%）发生围产儿死亡（OR 1.45[95%CI 0.76~2.76]；P=0.262）。总体而言，隐匿组中有35例（0.73%）新生儿发生严重并发症，显露组中有18例（0.38%）新生儿发生严重并发症（OR 0.58[95%CI 0.40~0.83]；P=0.003）。隐匿组中13例（0.27%）和显露组中9例（0.19%）新生儿发生严重神经系统疾病（OR 0.56[95%CI 0.25~1.24]；P=0.153）。隐匿组中23例（0.48%）新生儿发生严重的非神经系统疾病，显露组中9例（0.19%）新生儿发生严重的非神经系统疾病（0.58[95%CI 0.39~0.87]；P=0.009）。未收集母体不良事件。

解释

尽管与单独的胎儿生长评估相比，严重新生儿发病率显著降低，但基于超声胎儿生长评估和足月时脑胎盘比率的足月计划分娩并不能降低围产期死亡率。

英文原文如下：

Abstracts

BACKGROUND  The cerebroplacental ratio is associated with perinatal mortality and morbidity, but it is unknown whether routine measurement improves pregnancy outcomes. We aimed to evaluate whether the addition of cerebroplacental ratio measurement to the standard ultrasound growth assessment near term reduces perinatal mortality and severe neonatal morbidity, compared with growth assessment alone.

METHODS  RATIO37 was a randomised, open-label, multicentre, pragmatic trial, conducted in low-risk pregnant women, recruited from nine hospitals over six countries. The eligibility criteria were designed to be broad; participants were required to be 18 years or older, with an ultrasound-dated confirmed singleton pregnancy in the first trimester, an alive fetus with no congenital malformations at the routine second-trimester ultrasound, an absence of adverse medical or obstetric history, and the capacity to give informed consent. Women were randomly assigned in a 1:1 ratio (block size 100) using a web-based system to either the concealed group or revealed group. In the revealed group, the cerebroplacental ratio value was known by clinicians, and if below the fifth centile, a planned delivery after 37 weeks was recommended. In the concealed group, women and clinicians were blinded to the cerebroplacental ratio value. All participants underwent ultrasound at 36 + 0 to 37 + 6 weeks of gestation with growth assessment and Doppler evaluation. In both groups, planned delivery was recommended when the estimated fetal weight was below the tenth centile. The primary outcome was perinatal mortality from 24 weeks' gestation to infant discharge. The study is registered at ClinicalTrials.gov (NCT02907242) and is now closed.

FINDINGS  Between July 29, 2016, and Aug 3, 2021, we enrolled 11 214 women, of whom 9492 (84·6%) completed the trial and were eligible for analysis (4774 in the concealed group and 4718 in the revealed group). Perinatal mortality occurred in 13 (0·3%) of 4774 pregnancies in the concealed group and 13 (0·3%) of 4718 in the revealed group (OR 1·45 [95% CI 0·76-2·76]; p=0·262). Overall, severe neonatal morbidity occurred in 35 (0·73%) newborns in the concealed group and 18 (0·38%) in the revealed group (OR 0·58 [95% CI 0·40-0·83]; p=0·003). Severe neurological morbidity occurred in 13 (0·27%) newborns in the concealed group and nine (0·19%) in the revealed group (OR 0·56 [95% CI 0·25-1·24]; p=0·153). Severe non-neurological morbidity occurred in 23 (0·48%) newborns in the concealed group and nine (0·19%) in the revealed group (0·58 [95% CI 0·39-0·87]; p=0·009). Maternal adverse events were not collected.

INTERPRETATION  Planned delivery at term based on ultrasound fetal growth assessment and cerebroplacental ratio at term was not followed by a reduction of perinatal mortality although significantly reduced severe neonatal morbidity compared with fetal growth assessment alone.

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