Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number of participants with hypertensive disorders of pregnancy
研究概览
简要总结
The present study is a single-centre prospective study that will enrol pregnant women during their first trimester of pregnancy (11+0 - 13+6 weeks of gestation).
During pregnancy, women will undergo standard clinical evaluation and management. During the two study visits (enrollment and 24+0 - 27+6 weeks of gestation) the investigators will perform arterial tonometry (Pulsepen) and in vivo darkfield microscopy (Glycocheck) to evaluate endothelial and vascular function. A urine sample and a blood sample for specific study analyses on metabolic profile, endothelial and angiogenic markers will be collected. Pregnancy outcomes will be collected at delivery and five years after delivery all the participants will be interview to collect long-term cardiovascular outcomes. Serum endothelial and angiogenic markers will be evaluated only in participants who will develop hypertensive disorders of pregnancy and in an equal number of controls matched for age and body mass index at the time of conception.
详细描述
Primary aim:
To determine the role of the combination of arterial tonometry and endothelial glycocalyx measurement in predicting the risk of developing hypertensive disorders in pregnancy.
Secondary aims:
- To determine the association between circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1) and the development of hypertensive disorders of pregnancy.
- To define the trends of serum uric acid, lipids and xanthine oxidase activity in normotensive and hypertensive pregnancies.
- To determine the ability of the combination of arterial tonometry and endothelial glycocalyx measurement, performed in the two study visits during pregnancy, in predicting the risk of long-term maternal cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 18 years
- •Single pregnancy
- •No previous pregnancies lasting more than 12 weeks
- •Participant willing and able to give informed consent for participation in the study
排除标准
- •Intermediate-high risk of genetic abnormalities and/or need to perform invasive tests (amniocentesis, villocentesis)
- •History of solid organ or hematopoietic stem cell transplantation
- •Chronic renal failure (eGFR≤45ml/min/1.73m2)
- •Chronic treatment with antihypertensive drugs and/or xanthine oxidase (XO) inhibitors
结局指标
主要结局
Number of participants with hypertensive disorders of pregnancy
时间窗: From date of enrolment until the date of first documented diagnosis of hypertensive disorder of pregnancy, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery
Number of participants diagnosed during pregnancy with any hypertensive disorder of pregnancy
Perfused Boundary Region (PBR)
时间窗: Follow-up visit (24/27+6 weeks of pregnancy)
Micron
Carotid-femoral pulse wave velocity (cf-PWV)
时间窗: Follow-up visit (24/27+6 weeks of pregnancy)
m/s
Number of participants with preeclampsia
时间窗: From date of enrolment until the date of first documented diagnosis of preeclampsia, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery
Number of participants diagnosed during pregnancy with preeclampsia according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.
次要结局
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)(Follow-up visit (24/27+6 weeks of pregnancy))
- Number of participants with long-term cardiovascular outcomes(Interview 5 years after delivery)
- Serum Angiopoietin 1 (ANG-1)(Follow-up visit (24/27+6 weeks of pregnancy))
- Serum Angiopoietin 2 (ANG-2)(Follow-up visit (24/27+6 weeks of pregnancy))
- Serum Endothelin-1 (ET-1)(Follow-up visit (24/27+6 weeks of pregnancy))
- Serum Intercellular adhesion molecule-1 (ICAM-1)(Follow-up visit (24/27+6 weeks of pregnancy))