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早产子痫前期的筛查与预防:在现实环境中实施的综合方法。

Preterm preeclampsia screening and prevention: a comprehensive approach to implementation in a real-world setting.

作者信息

Ronzoni Stefania, Rashid Shamim, Santoro Aimee, Mei-Dan Elad, Barrett Jon, Okun Nanette, Huang Tianhua

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Dan Women & Babies Program, Toronto, ON, Canada.

Genetic Program, North York General Hospital, Toronto, ON, Canada.

出版信息

BMC Pregnancy Childbirth. 2025 Jan 15;25(1):32. doi: 10.1186/s12884-025-07154-6.

DOI:10.1186/s12884-025-07154-6
PMID:39815166
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11734365/
Abstract

BACKGROUND

Preeclampsia significantly impacts maternal and perinatal health. Early screening using advanced models and primary prevention with low-dose acetylsalicylic acid for high-risk populations is crucial to reduce the disease's incidence. This study assesses the feasibility of implementing preterm preeclampsia screening and prevention by leveraging information from our current aneuploidy screening program in a real-world setting with geographic separation clinical site and laboratory analysis site.

METHODS

A prospective cohort study involved pregnant individuals undergoing nuchal translucency scans between 11 and 14 weeks. Risk for preterm preeclampsia was assessed using the Fetal Medicine Foundation algorithm, which includes maternal risk factors, uterine artery Doppler, mean arterial pressure and serum markers (Placental growth factor, PlGF and Pregnancy-associated plasma protein-A, PAPP-A). High-risk patients were offered low-dose acetylsalicylic acid prophylaxis. Feasibility outcomes, such as recruitment rates, protocol adherence, operational impact, integration with existing workflows, screening performance and pregnancy outcomes, were evaluated.

RESULTS

Out of 974 participants, 15.6% were deemed high-risk for preterm preeclampsia. The study achieved high recruitment (82.1%) and adherence rates, with 95.4% of high-risk patients prescribed low-dose acetylsalicylic acid. Screening performance, adjusted for low-dose acetylsalicylic acid use, showed a detection rate of 88.9-90% (FPR 13.0% and 12.7%) for preterm preeclampsia. High-risk group for preeclampsia had higher incidences of adverse outcomes, including preterm preeclampsia (7.5 vs 0.4%; p < 0.001), preterm delivery (21.2 vs 6.2%; p < 0.001), low birth weight (23.3 vs 5.6%; p < 0.001) and birthweight < 10th percentile (11% vs 5.6%; p = 0.015) compared to low-risk group. The integration of preeclampsia screening had a minimal effect on the time required for aneuploidy screening, with results obtained within a rapid turnaround time.

CONCLUSIONS

The study confirms the feasibility of integrating comprehensive preeclampsia screening into clinical practice, notwithstanding geographic separation between laboratory and clinical settings. It underscores the need for broader adoption and enhanced infrastructure to optimize patient care and outcomes across diverse healthcare settings.

TRIAL REGISTRATION

Clinical trial: NCT04412681 (2020-06-02).

摘要

背景

子痫前期对孕产妇和围产期健康有重大影响。使用先进模型进行早期筛查以及对高危人群采用小剂量乙酰水杨酸进行一级预防对于降低该疾病的发病率至关重要。本研究评估了在临床地点和实验室分析地点存在地理分隔的现实环境中,利用当前非整倍体筛查项目的信息实施早产子痫前期筛查和预防的可行性。

方法

一项前瞻性队列研究纳入了在孕11至14周期间接受颈部透明带扫描的孕妇。使用胎儿医学基金会算法评估早产子痫前期风险,该算法包括孕产妇风险因素、子宫动脉多普勒、平均动脉压和血清标志物(胎盘生长因子,PlGF和妊娠相关血浆蛋白A,PAPP - A)。为高危患者提供小剂量乙酰水杨酸预防。评估了招募率、方案依从性、操作影响、与现有工作流程的整合、筛查性能和妊娠结局等可行性结果。

结果

在974名参与者中,15.6%被认为有早产子痫前期的高危风险。该研究实现了高招募率(82.1%)和依从率,95.4%的高危患者被开具了小剂量乙酰水杨酸。在调整小剂量乙酰水杨酸使用情况后,早产子痫前期的筛查性能显示检测率为88.9 - 90%(假阳性率分别为13.0%和12.7%)。子痫前期高危组不良结局的发生率更高,包括早产子痫前期(7.5%对0.4%;p < 0.001)、早产(21.2%对6.2%;p < 0.001)、低出生体重(23.3%对5.6%;p < 0.001)以及出生体重低于第10百分位数(11%对5.6%;p = 0.015),与低危组相比。子痫前期筛查的整合对非整倍体筛查所需时间影响极小,结果能在快速周转时间内获得。

结论

该研究证实了将全面的子痫前期筛查纳入临床实践的可行性,尽管实验室和临床环境之间存在地理分隔。它强调了需要更广泛地采用并加强基础设施建设,以优化不同医疗环境下的患者护理和结局。

试验注册

临床试验:NCT04412681(2020 - 06 - 02)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1240/11734365/37ede4de4e80/12884_2025_7154_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1240/11734365/37ede4de4e80/12884_2025_7154_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1240/11734365/37ede4de4e80/12884_2025_7154_Fig1_HTML.jpg

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本文引用的文献

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First-Trimester Screening Program for the Risk of Pre-eclampsia Using a Multiple-Marker Algorithm: A Health Technology Assessment.早孕期子痫前期风险的多标记物算法筛查方案:一项卫生技术评估。
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Aspirin Use for Preeclampsia Prevention Among Women With Prepregnancy Diabetes, Obesity, and Hypertension.阿司匹林用于预防孕前糖尿病、肥胖和高血压的子痫前期。
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