RecruitingNCT06912477

Endothelial Dysfunction for Prognosis In Patients With preeClampSia

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


Sponsor

Heidelberg University

Enrollment

385 participants

Start Date

May 8, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a test of blood vessel function in the skin (endothelial dysfunction testing) can predict the severity of preeclampsia — a serious high blood pressure condition that can develop during pregnancy. **You may be eligible if...** - You are 18 or older - You are pregnant with one baby (singleton pregnancy) - You are willing to provide written consent **You may NOT be eligible if...** - You have not provided consent - There is a language barrier preventing participation - You have very dark skin (which can affect the measurement technique used) - Your baby has serious chromosomal, genetic, or structural abnormalities - Low platelets or abnormal lab results are due to a cause other than preeclampsia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTHyperspectral 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_TESTFurther 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

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NCT06912477


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