About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Chronic hypertension diagnosed before pregnancy.
Multiple pregnancy.
Pre-existing diabetes mellitus.
Chronic kidney disease.
Trial population
The study population will include pregnant women aged 18 years and older recruited from the outpatient clinics of the Department of Obstetrics and Gynecology, University Hospital Centre Osijek, Croatia. Participants will comprise normotensive pregnant women and women with newly diagnosed hypertensive disorders of pregnancy, including gestational hypertension and preeclampsia, diagnosed according to current international clinical guidelines.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Plasma endothelial extracellular vesicle concentration
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
Secondary outcomes
Post-occlusive reactive hyperemia (PORH)
Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
Acetylcholine-induced vasodilation (AChID)
Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
Sodium nitroprusside-induced vasodilation (SNPID)
Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
VCAM-1 concentration
Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
Sponsors and contacts
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Josip Juraj Strossmayer University of Osijek
Lead sponsor
Osijek University Hospital
Collaborator