An observational study in Preeclampsia (PE) and Hypertensive Disorder of Pregnancy, sponsored by Heidelberg University. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Heidelberg University · Observational
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.
Preeclampsia is defined as hypertension combined with features of multi-organ dysfunction and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial dysfunction is a key driver in the pathophysiology of preeclampsia mediating the systemic complications of this multi-organ disease. Changes in endothelial and vascular function in preeclampsia have been observed through reduced flow-mediated vasodilation, which occurs due to diminished nitric oxide availability and may persist for years after childbirth. Although symptoms of preeclampsia often resolve spontaneously after delivery, affected women will face a significantly increased risk of long-term cardiovascular complications. Thus, preeclampsia is viewed as an individual female-specific cardiovascular risk factor.
Beyond this background, hyperspectral imaging as an assessment of peripheral microcirculation and tissue perfusion appears to be a suitable method. Hyperspectral imaging is an innovative technique that visualizes hemodynamic changes by displaying the oxygen saturation of hemoglobin in the capillary system, the distribution of hemoglobin in the tissue, and the relative tissue water content. Hyperspectral imaging has not yet been studied in obstetrics or in the context of preeclampsia before. Given the well-documented microcirculatory disturbances associated with preeclampsia, the investigators hypothesize hyperspectral analysis as a valuable tool to bridge a diagnostic gap that might be useful to tailor individualized obstetric care of patients with preeclampsia.
Recently the "Endothelial Activation and Stress Index" (EASIX) was evaluated as prognostic marker in preeclampsia by the investigator group. EASIX is based on lactate dehydrogenase, platelets, and creatinine and was originally developed as simple score to predict endothelial-related complications after allogenic stem cell transplantation. However, the exact relationship of EASIX to endothelial cell biology and microcirculation requires further clarification. The investigators hypothesize that a reduced peripheral microcirculation will mediate direct interactions of platelets with endothelial cells, resulting in cellular damage (increased LDH), loss of platelets due to activation and microembolism, and lead to kidney damage.
The EPICS study (Endothelial dysfunction for Prognosis In patients with preeClampSia) is the first prospective study to investigate hyperspectral imaging in women with preeclampsia. The aim of this study is to evaluate whether and how changes in microcirculation in women with preeclampsia can be detected with hyperspectral imaging compared to women with pregnancy-induced hypertension, normotensive pregnant women and non-pregnant controls and whether microcirculatory perfusion quality is associated with other biochemical markers such as EASIX or markers of endothelial dysfunction. Furthermore, the EPICS study aims to evaluate the predictive performance of hyperspectral imaging with or without combination of other biochemical markers for adverse maternal and perinatal outcomes and the remaining time until delivery in patients with preeclampsia.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 385 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
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Patients who are admitted to the Department of obstetrics at Heidelberg University Hospital
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with diagnosis of preeclampsia according to definitions by the International Society for the Study of Hypertension in Pregnancy (n=110)
Diagnostic Test: Hyperspectral imaging · Diagnostic Test: Further markers of endothelial dysfunction
patients with hypertension in pregnancy without fulfilling criteria of preeclampsia (n=110)
Diagnostic Test: Hyperspectral imaging · Diagnostic Test: Further markers of endothelial dysfunction
normotensive pregnancies (n=110)
Diagnostic Test: Hyperspectral imaging · Diagnostic Test: Further markers of endothelial dysfunction
normotensive, non-pregnant women (n=55)
Diagnostic Test: Hyperspectral imaging · Diagnostic Test: Further markers of endothelial dysfunction
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.
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.
Time Until Delivery
Time period between date of study inclusion (diagnostic tests) to delivery
Time frame: observation period until 6 months after delivery
maternal adverse event
composite adverse maternal outcome (categorical, yes/no): death, acute kidney injury, cardiorespiratory complication (e.g. pulmonary edema), eclampsia, cerebrovascular event, hematological complication, hepatic complication, postpartum hemorrhage, the Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome, placental abruption
Time frame: observation period until 6 months after delivery
perinatal adverse event
composite perinatal endpoint (categorical, yes/no): neonatal mortality, stillbirth, preeclampsia-related preterm delivery, respiratory distress syndrome, neonatal seizures, intraventricular hemorrhage, necrotizing enterocolitis, birthweight \<10th percentile, admission to neonatal unit, respiratory support
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: persistence of hypertension
number of participants with persisting hypertension
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: blood pressure
blood pressure (mmHg)
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: antihypertensive medication
number of participants who required antihypertensive medication initiation or dose adjustment
Time frame: observation period until 6 months after delivery
maternal cardiovascular outcome: readmission
number of participants who required readmission for hypertension
Time frame: observation period until 6 months after delivery
Plan to share: Undecided
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Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 19 months is below that.
Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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