Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertensive Disorder of Pregnancy, Gestational Hypertension, Preeclampsia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy
Overview
Hypertensive disorders of pregnancy are associated with endothelial dysfunction and increased maternal and fetal morbidity. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their relationship with blood pressure and endothelial function during pregnancy remains incompletely understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive pregnant women and pregnant women with hypertensive disorders of pregnancy. The study will also investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and circulating biomarkers of endothelial activation. The findings may improve understanding of endothelial injury during pregnancy and support the development of non-invasive biomarkers for early detection and monitoring of hypertensive disorders of pregnancy.
Primary outcome measures
- Plasma endothelial extracellular vesicle concentration [Time frame: Baseline]
Secondary outcome measures (8)
- Post-occlusive reactive hyperemia (PORH) [Time frame: Baseline]
- Acetylcholine-induced vasodilation (AChID) [Time frame: Baseline]
- Sodium nitroprusside-induced vasodilation (SNPID) [Time frame: Baseline]
- VCAM-1 concentration [Time frame: Baseline]
- ICAM-1 concentration [Time frame: Baseline]
- Endocan concentration [Time frame: Baseline]
- von Willebrand factor (vWF) [Time frame: Baseline]
- Matrix metalloproteinase-9 (MMP-9) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Pregnant women aged ≥18 years.
- Singleton pregnancy.
- Ability to provide written informed consent.
- Normotensive pregnancy or diagnosis of gestational hypertension or preeclampsia according to current clinical guidelines.
- Ability to comply with study procedures.
Exclusion criteria
- Chronic hypertension diagnosed before pregnancy.
- Multiple pregnancy.
- Pre-existing diabetes mellitus.
- Chronic kidney disease.
- Autoimmune disease.
- Known cardiovascular disease.
- Active infection or inflammatory disease.
- Malignancy.
- Inability or unwillingness to provide informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Croatia · 1 center
- Faculty of Medicine Osijek — Osijek
Identifiers
NCT: NCT07728656 · HYPER-endoEV-pregnancy