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RECRUITINGOBSERVATIONAL

Endothelial Dysfunction for Prognosis In Patients With preeClampSia

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - singleton pregnancies - Age ≥ 18 years - Patient's ability to provide consent - written willing to sign a consent form Who Should NOT Join This Trial: - Lack of consent - Language barrier - Dark to very dark skin type - Severe fetal chromosomal/genetic/structural anomalies - Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * singleton pregnancies * Age ≥ 18 years * Patient's ability to provide consent * written informed consent Exclusion Criteria: * Lack of consent * Language barrier * Dark to very dark skin type * Severe fetal chromosomal/genetic/structural anomalies * Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma)

Treatments Being Tested

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