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)02357-7

摘要内容如下：

背景

基于胎盘生长因子（PlGF）的检测在预测需要分娩的先兆子痫方面具有很高的诊断准确性，显著缩短了诊断时间和严重的母体不良结局。基于PLGF的重复检测的临床益处尚不清楚。我们的目的是确定重复的基于PLGF的检测（使用临床管理算法和国家推荐的阈值）是否能减少疑似早产先兆子痫孕妇的不良围产期结局。

方法

在这项多中心、平行组、优势、随机对照试验中，我们在英格兰、苏格兰和威尔士的22个产科病房招募了年龄在18岁或以上、妊娠22周至0天和妊娠35周至6天的疑似先兆子痫妇女。妇女被随机分配（1:1）进行基于PLGF的显性重复检测或常规护理的隐性重复检测。由于试验的性质，该干预措施不会对女性或伴侣、临床医生或数据收集者隐瞒。试验统计员对干预分配不知情。主要转归是死产、早期新生儿死亡或入住新生儿病房的围产期复合因素。主要分析是根据意向治疗原则进行的，符合方案分析仅限于根据其分配组管理的妇女。该试验在ISRCTN注册中心（ISRCTN 85912420）进行了前瞻性注册。

调查结果

在2019年12月17日至2022年9月30日期间，招募了1253名孕妇并随机分配治疗；一名患者因随机误差而被排除。625名妇女被分配接受基于PLGF的显性重复检测，627名妇女被分配接受基于PLGF的隐性重复检测的常规护理（平均年龄32.3[SD 5.7]岁；879[70%]白色）。基于PLGF的隐匿性重复测试组中的一名女性失访。以PLGF为基础的显性重复试验组（625名妇女中有195名[31.2%]）与以PLGF为基础的隐性重复试验组（626名妇女中有174名[27.8%]）相比，主要围产期复合结局无显著差异。相对危险度1.21[95%CI 0.95~1.33]；P=0.18）。符合方案分析的结果相似。基于显性重复PLGF的测试组中有4例严重不良事件，基于隐性重复PLGF的测试组中有6例严重不良事件；所有严重不良事件均被认为与研究机构主要研究者和首席研究者的干预无关。

解释

在疑似先兆子痫的孕妇中，基于PLGF的重复检测与改善围产期结局无关。在不良结局发生率较低的高收入环境中，不建议对所有疑似先兆子痫患者进行普遍的、基于PLGF的常规重复检测。

英文原文如下：

Abstracts

BACKGROUND  Placental growth factor (PlGF)-based testing has high diagnostic accuracy for predicting pre-eclampsia needing delivery, significantly reducing time to diagnosis and severe maternal adverse outcomes. The clinical benefit of repeat PlGF-based testing is unclear. We aimed to determine whether repeat PlGF-based testing (using a clinical management algorithm and nationally recommended thresholds) reduces adverse perinatal outcomes in pregnant individuals with suspected preterm pre-eclampsia.

METHODS  In this multicentre, parallel-group, superiority, randomised controlled trial, done in 22 maternity units across England, Scotland, and Wales, we recruited women aged 18 years or older with suspected pre-eclampsia between 22 weeks and 0 days of gestation and 35 weeks and 6 days of gestation. Women were randomly assigned (1:1) to revealed repeat PlGF-based testing or concealed repeat testing with usual care. The intervention was not masked to women or partners, or clinicians or data collectors, due to the nature of the trial. The trial statistician was masked to intervention allocation. The primary outcome was a perinatal composite of stillbirth, early neonatal death, or neonatal unit admission. The primary analysis was by the intention-to-treat principle, with a per-protocol analysis restricted to women managed according to their allocation group. The trial was prospectively registered with the ISRCTN registry, ISRCTN 85912420.

FINDINGS  Between Dec 17, 2019, and Sept 30, 2022, 1253 pregnant women were recruited and randomly assigned treatment; one patient was excluded due to randomisation error. 625 women were allocated to revealed repeat PlGF-based testing and 627 women were allocated to usual care with concealed repeat PlGF-based testing (mean age 32·3 [SD 5·7] years; 879 [70%] white). One woman in the concealed repeat PlGF-based testing group was lost to follow-up. There was no significant difference in the primary perinatal composite outcome between the revealed repeat PlGF-based testing group (195 [31·2%]) of 625 women) compared with the concealed repeat PlGF-based testing group (174 [27·8%] of 626 women; relative risk 1·21 [95% CI 0·95-1·33]; p=0·18). The results from the per-protocol analysis were similar. There were four serious adverse events in the revealed repeat PlGF-based testing group and six in the concealed repeat PlGF-based testing group; all serious adverse events were deemed unrelated to the intervention by the site principal investigators and chief investigator.

INTERPRETATION  Repeat PlGF-based testing in pregnant women with suspected pre-eclampsia was not associated with improved perinatal outcomes. In a high-income setting with a low prevalence of adverse outcomes, universal, routine repeat PlGF-based testing of all individuals with suspected pre-eclampsia is not recommended.

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