Face to Face With Preeclampsia: Understanding Its Origin, Characteristics and Effects on Mother and Baby
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1
研究概览
简要总结
Preeclampsia (PE) is a serious pregnancy complication characterized by new-onset hypertension and signs of maternal organ dysfunction, often accompanied by placental abnormalities and systemic endothelial dysfunction. PE is associated with adverse maternal and perinatal outcomes and confers an increased long-term risk of cardiovascular and metabolic disease for both mother and offspring.
This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with preeclampsia. Pregnant women with a clinical diagnosis of PE according to current obstetric guidelines will be recruited at their initial presentation either in the in- or outpatient clinic or in the delivery ward, respectively and followed through late pregnancy, delivery, and early postpartum.
Participants will undergo study visits during pregnancy, sample collection at delivery, and a postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of pregnancies complicated by preeclampsia.
Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of preeclampsia-associated biological and clinical changes.
详细描述
Preeclampsia (PE) is a pregnancy-specific hypertensive disorder characterized by new-onset hypertension and signs of maternal organ dysfunction, often accompanied by placental abnormalities and systemic endothelial dysfunction. PE is associated with increased perinatal morbidity and an elevated long-term risk for cardiovascular and metabolic disease in both mothers and offspring. Despite its clinical relevance, the biological mechanisms underlying PE and its long-term consequences are not fully understood.
This prospective, monocentric observational cohort study is designed to establish a well-characterized longitudinal pregnancy and birth cohort of women diagnosed with PE. The primary objective is to collect clinical data and biological samples across pregnancy, delivery, and early postpartum to support detailed phenotyping of PE pregnancies and early-life outcomes.
Approximately 50 pregnant women with a confirmed diagnosis of PE will be recruited per year at the Department of Obstetrics and Gynecology. Eligible participants are women aged 18 years or older with an ongoing pregnancy and a clinical diagnosis of PE according to current obstetric guidelines. Women with major fetal anomalies are excluded.
Study participation includes four time points:
- optional: a visit following PE diagnosis,
- optional: a late pregnancy visit,
- sample and clinical data collection at delivery, and
- a postpartum follow-up visit 8-12 weeks after birth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ongoing pregnancy with preeclampsia regardless the gestational age diagnosed for PE
排除标准
- •Maternal or fetal genetic abnormalities
结局指标
主要结局
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1
时间窗: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Vicorder
Maternal metabolic and cardiometabolic phenotype: Adiposity
时间窗: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 2
时间窗: from study enrollment after PE diagnosis through 8-12 weeks postpartum
USCOM 1A
Maternal metabolic and cardiometabolic phenotype: Cytokine Profile
时间窗: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Assessment of inflammatory parameters in serum and plasma
Maternal metabolic and cardiometabolic phenotype: Lipid profile
时间窗: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Lipid profile: triglycerides, free fatty acids, phospholipids, HDL/LDL/total cholesterol
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 3
时间窗: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Retina scan
Maternal metabolic and cardiometabolic phenotype: Echocardiography
时间窗: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Echocardiography
Infant outcomes: hemodynamic assessment
时间窗: At birth and at 8-12 weeks postpartum
Blood pressure measurement (systolic and diastolic)
Infant outcomes: body composition
时间窗: At birth and at 8-12 weeks postpartum
fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
次要结局
未报告次要终点