Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorJosip Juraj Strossmayer University of Osijek

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Normotensive Pregnancy
Group B: Hypertensive Disorders of Pregnancy

Trial outcomes

Primary outcomes

1

Plasma endothelial extracellular vesicle concentration

Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

Time frame
Baseline

Secondary outcomes

1

Post-occlusive reactive hyperemia (PORH)

Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.

Time frame
Baseline
2

Acetylcholine-induced vasodilation (AChID)

Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.

Time frame
Baseline
3

Sodium nitroprusside-induced vasodilation (SNPID)

Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.

Time frame
Baseline
4

VCAM-1 concentration

Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Josip Juraj Strossmayer University of Osijek

Lead sponsor

Osijek University Hospital

Collaborator