Prospective Validation of First-Trimester Screening for Preterm Preeclampsia in Nulliparous Women (PREDICTION Study).

IF 6.9 1区医学 Q1 PERIPHERAL VASCULAR DISEASE Hypertension Pub Date : 2024-07-01 Epub Date: 2024-05-06 DOI:10.1161/HYPERTENSIONAHA.123.22584

Paul Guerby, Francois Audibert, Jo-Ann Johnson, Nanette Okun, Yves Giguère, Jean-Claude Forest, Nils Chaillet, Benoit Mâsse, David Wright, Louise Ghesquiere, Emmanuel Bujold

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Abstract

Background: Fetal Medicine Foundation (FMF) studies suggest that preterm preeclampsia can be predicted in the first trimester by combining biophysical, biochemical, and ultrasound markers and prevented using aspirin. We aimed to evaluate the FMF preterm preeclampsia screening test in nulliparous women.

Methods: We conducted a prospective multicenter cohort study of nulliparous women recruited at 11 to 14 weeks. Maternal characteristics, mean arterial blood pressure, PAPP-A (pregnancy-associated plasma protein A), PlGF (placental growth factor) in maternal blood, and uterine artery pulsatility index were collected at recruitment. The risk of preterm preeclampsia was calculated by a third party blinded to pregnancy outcomes. Receiver operating characteristic curves were used to estimate the detection rate (sensitivity) and the false-positive rate (1-specificity) for preterm (<37 weeks) and for early-onset (<34 weeks) preeclampsia according to the FMF screening test and according to the American College of Obstetricians and Gynecologists criteria.

Results: We recruited 7554 participants including 7325 (97%) who remained eligible after 20 weeks of which 65 (0.9%) developed preterm preeclampsia, and 22 (0.3%) developed early-onset preeclampsia. Using the FMF algorithm (cutoff of ≥1 in 110 for preterm preeclampsia), the detection rate was 63.1% for preterm preeclampsia and 77.3% for early-onset preeclampsia at a false-positive rate of 15.8%. Using the American College of Obstetricians and Gynecologists criteria, the equivalent detection rates would have been 61.5% and 59.1%, respectively, for a false-positive rate of 34.3%.

Conclusions: The first-trimester FMF preeclampsia screening test predicts two-thirds of preterm preeclampsia and three-quarters of early-onset preeclampsia in nulliparous women, with a false-positive rate of ≈16%.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02189148.

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无先兆子痫妇女一胎先兆子痫筛查的前瞻性验证（PREDICTION 研究）。

背景：胎儿医学基金会（FMF）的研究表明，通过结合生物物理、生物化学和超声标记物，可以在妊娠头三个月预测先兆子痫，并使用阿司匹林预防先兆子痫。我们的目的是评估 FMF 非妊娠妇女子痫前期筛查试验：我们进行了一项前瞻性多中心队列研究，研究对象为 11 至 14 周的无子宫妇女。在招募时收集了母体特征、平均动脉血压、PAPP-A（妊娠相关血浆蛋白 A）、母体血液中的 PlGF（胎盘生长因子）和子宫动脉搏动指数。先兆子痫的风险由对妊娠结果保密的第三方计算。使用受体操作特征曲线估算先兆子痫的检出率（灵敏度）和假阳性率（1-特异性）：我们共招募了 7554 名参与者，其中 7325 人（97%）在妊娠 20 周后仍符合条件，其中 65 人（0.9%）罹患早发型子痫前期，22 人（0.3%）罹患早发型子痫前期。使用 FMF 算法（早产子痫前期的临界值为 110 分之≥1），早产子痫前期的检出率为 63.1%，早发子痫前期的检出率为 77.3%，假阳性率为 15.8%。根据美国妇产科医师学会的标准，相应的检出率分别为61.5%和59.1%，假阳性率为34.3%：第一孕期FMF子痫前期筛查试验可预测三分之二的早产子痫前期和四分之三的无子宫妇女早发子痫前期，假阳性率≈16%：URL：https://www.clinicaltrials.gov；唯一标识符：NCT02189148。

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来源期刊

Hypertension 医学-外周血管病

CiteScore

15.90

自引率

4.80%

发文量

1006

审稿时长

1 months

期刊介绍： Hypertension presents top-tier articles on high blood pressure in each monthly release. These articles delve into basic science, clinical treatment, and prevention of hypertension and associated cardiovascular, metabolic, and renal conditions. Renowned for their lasting significance, these papers contribute to advancing our understanding and management of hypertension-related issues.