Endothelial Dysfunction for Prognosis In Patients With preeClampSia

ConditionsPreeclampsia (PE)Hypertensive Disorder of Pregnancy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorHeidelberg University

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

singleton pregnancies

Age ≥ 18 years

Patient's ability to provide consent

written informed consent

Disqualifiers

Lack of consent

Language barrier

Dark to very dark skin type

Severe fetal chromosomal/genetic/structural anomalies

Trial population

Patients who are admitted to the Department of obstetrics at Heidelberg University Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Hyperspectral imaging
Diagnostic test
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.
Further markers of endothelial dysfunction
Diagnostic test
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.

Treatment groups

385 Participants

are divided into 4 treatment groups

Group A: Preeclampsia2 interventions

Group B: Pregnancy induced Hypertension and chronic Hypertension2 interventions

Group C: Normotensive pregnant control group2 interventions

Group D: Non-pregnant control group2 interventions

Trial outcomes