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子痫前期筛查和预防(IMPRESS)研究。

The Implementation of Preeclampsia Screening and Prevention (IMPRESS) Study.

机构信息

Departments of Obstetrics and Gynecology (Drs J Johnson and Walsh, Ms Pastuck, Dr Metcalfe, Mr Maxey, and Drs Soliman, Kuret, Dwinnell, Chada, O'Quinn, Schacher, and Somerset).

Departments of Obstetrics and Gynecology (Drs J Johnson and Walsh, Ms Pastuck, Dr Metcalfe, Mr Maxey, and Drs Soliman, Kuret, Dwinnell, Chada, O'Quinn, Schacher, and Somerset).

出版信息

Am J Obstet Gynecol MFM. 2023 Feb;5(2):100815. doi: 10.1016/j.ajogmf.2022.100815. Epub 2022 Nov 15.

Abstract

BACKGROUND

Preeclampsia affects between 2% and 5% of pregnancies and is one of the leading causes of perinatal morbidity and mortality worldwide. Despite strong evidence that the combination of systematic preeclampsia screening based on the Fetal Medicine Foundation preeclampsia risk calculation algorithm with treatment of high-risk patients with low-dose aspirin reduces the incidence of preterm preeclampsia more than currently used risk-factor-based screening, real-world implementation studies have not yet been done in Canada.

OBJECTIVE

This study aimed to assess the operational feasibility of implementing first-trimester screening and prevention of preterm preeclampsia (<37 weeks) alongside a publicly funded first-trimester combined screening program for aneuploidies.

STUDY DESIGN

This was a prospective implementation study. Consecutive pregnant patients referred for first-trimester combined screening (11-13+6 weeks) were offered screening for preeclampsia based on the Fetal Medicine Foundation algorithm concomitantly with their aneuploidy screen. Consenting participants were screened using maternal risk factors, mean arterial pressure, uterine artery Doppler pulsatility index, pregnancy-associated plasma protein-A, and placental growth factor. Risk for preterm preeclampsia (<37 weeks) was calculated using the Fetal Medicine Foundation algorithm, and individuals with a risk score ≥1 per 100 were recommended to use aspirin (162 mg once daily at bedtime, <16-36 weeks). Implementation metrics assessed included: acceptability, operational impact, proportion of aspirin initiation, quality and safety measures, and screen performance.

RESULTS

Between December 1, 2020 and April 23, 2021, 1124 patients consented to preeclampsia screening (98.3% uptake), and 92 (8.2%) screened positive. Appointments for patients receiving first-trimester combined screening aneuploidy and preeclampsia screening averaged 6 minutes longer than first-trimester combined screening alone, and adding uterine artery Doppler pulsatility index averaged 2 minutes. Of the 92 patients who screened as high-risk for preeclampsia, 72 (78.3%) were successfully contacted before 16 weeks' gestation. Of these, 62 (86.1%) initiated aspirin, and 10 (13.9%) did not. Performance audit identified a consistent negative bias with mean arterial pressure measurements (median multiple of the median <1 in 10%); other variables were satisfactory. There were 7 cases of preterm preeclampsia (0.69%): 5 and 2 in the high- and low-risk groups, respectively. Screening detected 5 of 7 (71.4 %) preterm preeclampsia cases, with improved performance after adjustment for aspirin treatment effect.

CONCLUSION

This study confirms the operational feasibility of implementing an evidence-based preeclampsia screening and prevention program in a publicly funded Canadian setting. This will facilitate implementation into clinical service and the scaling up of this program at a regional and provincial level.

摘要

背景

子痫前期影响 2%-5%的妊娠,是全球围产期发病率和死亡率的主要原因之一。尽管有强有力的证据表明,基于胎儿医学基金会子痫前期风险计算算法的系统性子痫前期筛查与低剂量阿司匹林治疗高危患者相结合,可以降低早产子痫前期的发生率,超过目前使用的基于风险因素的筛查,但在加拿大尚未进行实际实施研究。

目的

本研究旨在评估在公共资助的早孕期联合筛查唐氏综合征的基础上,同时进行早孕期筛查和预防早产子痫前期(<37 周)的操作性。

研究设计

这是一项前瞻性实施研究。连续转诊进行早孕期联合筛查(11-13+6 周)的孕妇,同时根据胎儿医学基金会算法进行子痫前期筛查。同意参与的孕妇接受母体危险因素、平均动脉压、子宫动脉多普勒搏动指数、妊娠相关血浆蛋白-A 和胎盘生长因子的筛查。早产子痫前期(<37 周)的风险使用胎儿医学基金会算法进行计算,风险评分≥1/100 的个体建议使用阿司匹林(162mg 每日一次,睡前,<16-36 周)。评估的实施指标包括:可接受性、操作影响、阿司匹林起始比例、质量和安全性措施以及筛查性能。

结果

2020 年 12 月 1 日至 2021 年 4 月 23 日,1124 名孕妇同意进行子痫前期筛查(接受率为 98.3%),其中 92 名(8.2%)筛查呈阳性。接受早孕期联合筛查唐氏综合征和子痫前期筛查的患者预约时间平均比仅接受早孕期联合筛查长 6 分钟,而增加子宫动脉多普勒搏动指数则平均增加 2 分钟。在 92 名筛查为子痫前期高危的患者中,有 72 名(78.3%)在 16 周妊娠前成功联系。其中,62 名(86.1%)开始使用阿司匹林,10 名(13.9%)未使用。绩效审计发现平均动脉压测量存在一致的负偏倚(中位数<1 的中位数倍数<1 为 10%);其他变量均令人满意。有 7 例早产子痫前期(0.69%):高危组 5 例,低危组 2 例。筛查检测到 7 例早产子痫前期中的 5 例(71.4%),在调整阿司匹林治疗效果后,筛查性能有所提高。

结论

本研究证实了在公共资助的加拿大环境中实施基于证据的子痫前期筛查和预防计划的操作性。这将促进该计划在临床服务中的实施,并在区域和省级层面上扩大该计划的规模。

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