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

Hypertensive Disorder of Pregnancy Preeclampsia (PE)

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

Inclusion Criteria4

singleton pregnancies
Age ≥ 18 years
Patient's ability to provide consent
written informed consent

Exclusion Criteria5

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)

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.