2025-524646-94-00招募中4 期
Optimizing Aspirin Use for Preeclampsia Prevention
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca23 个研究点 分布在 1 个国家目标入组 11,836 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11,836
- 试验地点
- 23
研究概览
简要总结
To evaluate whether stopping ASA between weeks 24 and 26 is non-inferior in preventing preterm preeclampsia compared to the control group, which will continue ASA until week 36
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Ability to read and understand the informed consent
- •Singleton pregnancy
- •Having undergone first-trimester preeclampsia screening (11+0 to 13+6 weeks) using a multiparametric algorithm and being classified as high risk.
- •Voluntary informed consent signature and willing to comply with study protocol (including acceptance of aspirin [ASA] treatment, additional blood tests and ultrasounds, and the assigned treatment duration at randomization).
排除标准
- •Early pregnancy loss, stillbirth or fetus with major malformations
- •Fetus affected by a known genetic or chromosomal disease
- •Contraindication, allergy, or intolerance to aspirin (AAS)
- •Inability to discontinue aspirin (e.g., antiphospholipid syndrome, etc.)
研究组 & 干预措施
ACETYLSALICYLIC ACID
Test
干预措施: ACETYLSALICYLIC ACID (Drug)
结局指标
主要结局
未指定
次要结局
- Carry out a comprehensive clinical and economic analysis to assess the cost-effectiveness of the screening program and the incremental value of incorporating specific markers (PlGF, UtA-PI, and ophthalmic artery Doppler) in different socioeconomic contexts.
- Determine optimized risk thresholds specific to each population and performance metrics that facilitate the translation into evidence based policies and resource allocation in both European and African healthcare systems.
- Compare different methods for determining the placental growth factor (PlGF): point-of-care devices versus ELISA/ECLIA.
- To evaluate the role of the ophthalmic artery in the prediction of preeclampsia (PE).
- Develop models using clinical data, ultrasound markers, and biomarkers to predict cases that will develop preeclampsia despite adequate treatment with ASA.
研究者
Manel Mendoza Cobaleda
Scientific
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
研究点 (23)
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