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中孕期子宫动脉多普勒超声检查用于预测子痫前期高危孕妇的阿司匹林停药时机:STOPPRE 试验的事后分析。

Mid-trimester uterine artery Doppler for aspirin discontinuation in pregnancies at high risk for preterm pre-eclampsia: Post-hoc analysis of StopPRE trial.

机构信息

Maternal Fetal Medicine Unit, Department of Obstetrics, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.

Department of Obstetrics, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.

出版信息

BJOG. 2024 Feb;131(3):334-342. doi: 10.1111/1471-0528.17631. Epub 2023 Aug 9.

Abstract

OBJECTIVE

To assess whether aspirin treatment can be discontinued in pregnancies with normal uterine artery pulsatility index (≤90th percentile) at 24-28 weeks.

DESIGN

Post-hoc analysis of a clinical trial.

SETTING

Nine maternity hospitals in Spain.

POPULATION OR SAMPLE

Pregnant individuals at high risk of pre-eclampsia at 11-13 weeks and normal uterine artery Doppler at 24-28 weeks.

METHODS

All participants received treatment with daily aspirin at a dose of 150 mg. Participants were randomly assigned, in a 1:1 ratio, either to continue aspirin treatment until 36 weeks (control group) or to discontinue aspirin treatment (intervention group), between September 2019 and September 2021. In this secondary analysis, women with a UtAPI >90th percentile at 24-28 weeks were excluded. The non-inferiority margin was set at a difference of 1.9% for the incidence of preterm pre-eclampsia.

MAIN OUTCOME MEASURES

Incidence of preterm pre-eclampsia.

RESULTS

Of the 1611 eligible women, 139 were excluded for UtAPI >90th percentile or if UtAPI was not available. Finally, 804 were included in this post-hoc analysis. Preterm pre-eclampsia occurred in three of 409 (0.7%) women in the aspirin discontinuation group and five of 395 (1.3%) women in the continuation group (-0.53; 95% CI -1.91 to 0.85), indicating non-inferiority of aspirin discontinuation.

CONCLUSIONS

Discontinuing aspirin treatment at 24-28 weeks in women with a UtAPI ≤90th percentile was non-inferior to continuing aspirin treatment until 36 weeks for preventing preterm pre-eclampsia.

摘要

目的

评估在 24-28 周时子宫动脉搏动指数(≤90 百分位)正常的孕妇是否可以停止使用阿司匹林治疗。

设计

临床试验的事后分析。

地点

西班牙的 9 家产科医院。

人群或样本

11-13 周时患有子痫前期高危因素且 24-28 周时子宫动脉多普勒正常的孕妇。

方法

所有参与者均接受每日 150mg 阿司匹林治疗。参与者以 1:1 的比例随机分配,继续阿司匹林治疗至 36 周(对照组)或停止阿司匹林治疗(干预组),时间为 2019 年 9 月至 2021 年 9 月。在这项二次分析中,排除了 24-28 周时 UtAPI >90 百分位的女性。非劣效性边界设定为早产子痫前期发生率的差异为 1.9%。

主要观察指标

早产子痫前期的发生率。

结果

在 1611 名符合条件的女性中,有 139 名因 UtAPI >90 百分位或 UtAPI 不可用而被排除。最终,804 名女性被纳入这项事后分析。阿司匹林停药组 409 名女性中有 3 名(0.7%)发生早产子痫前期,继续治疗组 395 名女性中有 5 名(1.3%)(-0.53;95%CI-1.91 至 0.85),表明阿司匹林停药具有非劣效性。

结论

在 UtAPI ≤90 百分位的女性中,在 24-28 周时停止使用阿司匹林治疗与继续使用阿司匹林治疗至 36 周相比,预防早产子痫前期的效果非劣效。

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