Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies (PULSE)
Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies; a Multinational Study (PULSE)
研究概览
详细说明
Existing predictive tools for preeclampsia (PE), including clinical characteristics, blood pressure, blood biomarkers, and uterine artery Doppler indices, have, at best, moderate predictive properties. While maternal symptoms often resolve with the delivery of the placenta, the burden of PE extends beyond pregnancy; afflicted women are at 3.1-fold increased odds of developing hypertension and 2.3-fold increased odds for cardiovascular disease later in life compared to women with uncomplicated pregnancies. Placental pathogenic changes associated with PE occur weeks to months before clinical manifestations develop, presenting a window of opportunity to identify early those women who will develop PE. The goal of the study investigators is to capitalize on this window and develop strategies for early prediction of PE.
As a composite measure of vascular health, measurement of arterial stiffness and wave reflection could represent a promising non-invasive tool for PE prediction. This multi-national 5-year observational prospective study aims to recruit 2400 participants across 8 sites in Canada, the US, and the UK. Participants will undergo 2 assessments, one in the first trimester (10 - 13 weeks gestation) and one in the second trimester (18 - 21 weeks gestation), which involve vascular measurements (arterial stiffness, blood pressure), blood sample collection, psychosocial and demographic questionnaires, and Uterine Artery Doppler imaging (only at second visit). Post-natal outcome measurements will be collected via medical charts for each participant 6-8 weeks post-partum. The primary objective of the study is to determine if, and to what extent, arterial stiffness and wave reflection parameters improve early prediction of PE beyond that achieved by currently available predictors in high-risk pregnancies.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Helena Papacostas, PhD
- 电话号码:42478 514 934-1934
- 邮箱:helena.papacostasquintanilla@mail.mcgill.ca
学习地点
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Quebec
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Montreal、Quebec、加拿大、H3A 1A1
- 招聘中
- Royal Victoria Hospital
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首席研究员:
- Stella S Daskalopoulou, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Singleton pregnancy
- Presence of at least 1 high-risk factor or 2 moderate-risk factors for pre-eclampsia
Exclusion Criteria:
- >14 weeks gestation
- Multiple pregnancy
- History of heart disease, stroke, or peripheral arterial disease
- Infectious diseases/conditions, such as Hepatitis B/C, HIV, and COVID19
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Diagnosis of pre-eclampsia
大体时间:up to 6 weeks post-partum (after delivery)
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According to the Society of Obstetricians and Gynaecologists (SOGC) guidelines, upon the presence of 2 criteria: 1) hypertension; chronic (pre-dating pregnancy or diagnosed <20 weeks' gestation) or de novo/gestational (diagnosed ≥20 weeks') hypertension along with 2) de novo end-organ dysfunction
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up to 6 weeks post-partum (after delivery)
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合作者和调查者
合作者
调查人员
- 首席研究员:Stella S Daskalopoulou, MD, PhD、Research Institute of the McGill University Health Centre
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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