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丹麦子痫前期筛查(PRESIDE):全国验证研究。

Pre-eclampsia screening in Denmark (PRESIDE): national validation study.

机构信息

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Department of Obstetrics, Center of Fetal Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.

出版信息

Ultrasound Obstet Gynecol. 2023 Jun;61(6):682-690. doi: 10.1002/uog.26183. Epub 2023 May 5.

DOI:10.1002/uog.26183
PMID:36840981
Abstract

OBJECTIVES

To investigate the predictive performance of the Fetal Medicine Foundation (FMF) first-trimester screening algorithm for pre-eclampsia in a Danish population and compare screening performance with that of the current Danish strategy, which is based on maternal risk factors.

METHODS

This was a prospective study of women with a singleton pregnancy attending for their first-trimester ultrasound scan and screening for aneuploidies at six Danish university hospitals between May 2019 and December 2020. Prenatal data on maternal characteristics and medical history were recorded, and measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum pregnancy-associated plasma protein-A (PAPP-A) and serum placental growth factor (PlGF) were collected without performing a risk assessment for pre-eclampsia. Information on acetylsalicylic acid use was recorded. After delivery, pregnancy outcome, including gestational age at delivery and pre-eclampsia diagnosis, was recorded. Pre-eclampsia risk assessment for each woman was calculated blinded to outcome using the FMF screening algorithm following adjustment to the Danish population. Detection rates (DRs) of the FMF algorithm were calculated for a fixed screen-positive rate (SPR) of 10% and for the SPR achieved in the current Danish screening.

RESULTS

A total of 8783 pregnant women were included, with a median age of 30.8 (interquartile range (IQR), 28.1-33.9) years. The majority were white (95%), naturally conceiving (90%), non-smokers (97%) and had no family history of pre-eclampsia (96%). The median body mass index was 23.4 (IQR, 21.2-26.6) kg/m . A complete risk assessment including maternal characteristics, MAP, UtA-PI, PlGF and PAPP-A was available for 8156 women (92.9%). In these women, UtA-PI was measured bilaterally with a median value of 1.58 (IQR, 1.27-1.94) and the median resting MAP of 80.5 (IQR, 76.1-85.4) mmHg in two consecutive measurements. Among these, 303 (3.7%) developed pre-eclampsia, including 55 (0.7%) cases of pre-eclampsia with delivery < 37 weeks of gestation and 16 (0.2%) cases of pre-eclampsia with delivery < 34 weeks. At a SPR of 10%, combined screening using the FMF algorithm based on maternal characteristics, MAP, UtA-PI, PlGF and PAPP-A had a DR of 77.4% (95% CI, 57.6-97.2%) for pre-eclampsia with delivery < 34 weeks, 66.8% (95% CI, 54.4-79.1%) for pre-eclampsia with delivery < 37 weeks and 44.1% (95% CI, 38.5-49.7%) for pre-eclampsia with delivery at any gestational age. The current Danish screening strategy using maternal risk factors detected 25.0% of women with pre-eclampsia with delivery < 34 weeks and 19.6% of women with pre-eclampsia with delivery < 37 weeks at a SPR of 3.4%. When applying the FMF algorithm including maternal characteristics, MAP, UtA-PI and PlGF at the fixed SPR of 3.4%, the DRs were 60.5% (95% CI, 36.9-84.1%) for PE with delivery < 34 weeks and 45.2% (95% CI, 32.0-58.5%) for PE with delivery < 37 weeks.

CONCLUSION

In this large Danish multicenter study, the FMF algorithm based on maternal characteristics, MAP, UtA-PI, PlGF and PAPP-A predicted 77.4% of cases with pre-eclampsia with delivery < 34 weeks and 66.8% of cases with pre-eclampsia with delivery < 37 weeks of gestation at a SPR of 10%, suggesting that the performance of the algorithm in a Danish cohort matches that in other populations. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

摘要

目的

探讨丹麦人群中胎儿医学基金会(FMF)的第一孕期筛查算法预测子痫前期的表现,并将其与当前基于母体危险因素的丹麦策略的筛查表现进行比较。

方法

这是一项前瞻性研究,纳入了在 2019 年 5 月至 2020 年 12 月期间于丹麦六所大学医院就诊的单胎妊娠女性,进行第一孕期超声扫描和非整倍体筛查。记录了母体特征和病史的产前数据,并在不进行子痫前期风险评估的情况下测量了平均动脉压(MAP)、子宫动脉搏动指数(UtA-PI)、血清妊娠相关血浆蛋白-A(PAPP-A)和胎盘生长因子(PlGF)。记录了使用乙酰水杨酸的情况。分娩后,记录了妊娠结局,包括分娩时的胎龄和子痫前期的诊断。使用 FMF 筛查算法,在调整为丹麦人群后,对每个女性进行盲法的子痫前期风险评估。计算了固定的筛查阳性率(SPR)为 10%和当前丹麦筛查中获得的 SPR 的 FMF 算法的检出率(DR)。

结果

共纳入了 8783 名孕妇,中位年龄为 30.8(四分位距[IQR],28.1-33.9)岁。大多数是白人(95%),自然受孕(90%),不吸烟(97%),无子痫前期家族史(96%)。中位数体重指数为 23.4(IQR,21.2-26.6)kg/m2。8156 名女性(92.9%)进行了完整的风险评估,包括母体特征、MAP、UtA-PI、PlGF 和 PAPP-A。在这些女性中,双侧测量了 UtA-PI,中位值为 1.58(IQR,1.27-1.94),连续两次测量的中位静息 MAP 为 80.5(IQR,76.1-85.4)mmHg。其中,303 名(3.7%)发生子痫前期,包括 55 名(0.7%)子痫前期患者分娩<37 孕周,16 名(0.2%)子痫前期患者分娩<34 孕周。在 SPR 为 10%时,基于母体特征、MAP、UtA-PI、PlGF 和 PAPP-A 的 FMF 算法联合筛查,预测分娩<34 孕周的子痫前期的检出率为 77.4%(95%CI,57.6-97.2%),预测分娩<37 孕周的子痫前期的检出率为 66.8%(95%CI,54.4-79.1%),预测任何孕周分娩的子痫前期的检出率为 44.1%(95%CI,38.5-49.7%)。当前丹麦基于母体危险因素的筛查策略,在 SPR 为 3.4%时,检测到分娩<34 孕周的子痫前期患者的比例为 25.0%,检测到分娩<37 孕周的子痫前期患者的比例为 19.6%。当应用固定的 SPR 为 3.4%时,包括母体特征、MAP、UtA-PI 和 PlGF 的 FMF 算法,预测分娩<34 孕周的子痫前期的检出率为 60.5%(95%CI,36.9-84.1%),预测分娩<37 孕周的子痫前期的检出率为 45.2%(95%CI,32.0-58.5%)。

结论

在这项丹麦多中心的大型研究中,基于母体特征、MAP、UtA-PI、PlGF 和 PAPP-A 的 FMF 算法在 SPR 为 10%时预测了分娩<34 孕周的子痫前期的 77.4%和分娩<37 孕周的子痫前期的 66.8%,提示该算法在丹麦队列中的表现与其他人群相符。© 2023 作者。超声在妇产科由约翰威立父子出版公司代表国际超声在妇产科协会出版。

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