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RECRUITING
NCT06912477

Endothelial Dysfunction for Prognosis In Patients With preeClampSia

Sponsor: Heidelberg University

View on ClinicalTrials.gov

Summary

Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before. This EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.

Official title: Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

385

Start Date

2025-05-08

Completion Date

2027-07

Last Updated

2025-05-11

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Hyperspectral imaging

Hyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated. Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the Department of Gynecology and Obstetrics of the Heidelberg University Hospital.

DIAGNOSTIC_TEST

Further markers of endothelial dysfunction

At study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries. Blood samples will also be collected at the first and second day after delivery.

Locations (1)

Heidelberg University Hospital, Department of Gynecology and Obstetrics

Heidelberg, Germany