An observational study in Preeclampsia (PE) Risk and Preeclampsia, 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 hypertensive pregnancy disorder that can quickly lead to serious, potentially life-threatening outcomes for both the mother and the fetus. Typical features of preeclampsia are by endothelial and microvascular dysfunctionsNotably, such impairments in endothelial function may precede preeclampsia diagnosis and canpersist for years postpartum. In clinical practice, however, no predictive methods have yet been established that specifically reflect endothelial dysfunction in the context of preeclampsia.
Hyperspectral imaging represents a new and non-invasive imaging modality that allows contact-free visualization of peripheral microcirculatory dynamics and tissue perfusion. Despite its growing use in other medical fields, this technology has not yet been systematically studied to determine its predictive potential in preeclampsia.
The HIPPA project (Systematic Evaluation of Hyperspectral Analysis for Prediction of Preeclampsia) is a prospective observational study to evaluate the applicability of hyperspectral imaging as a new tool for prediction of preeclampsia.
Preeclampsia is defined by hypertension in pregnancy accompanied by any systemic end-organ dysfunction. The condition can develop rapidly and is associated with significant maternal and fetal morbidity and mortality. A key component of its underlying pathophysiology is the endothelial dysfunction, which contributes to the systemic nature of the disease and the impairment of various organ systems. Importantly, these vascular alterations may not be limited to the pregnancy period but can persist after delivery and mediate long-term cardiovascular complications. Additionally, these vascular changes seem to precede the development of preeclampsia and may contribute to its pathogenesis. Pregnancy itself is often viewed as a stress test aggravating preexisting maternal subclinical cardiovascular dysfunction. Cardiovascular disease and preeclampsia are closely linked as both entities share the same risk factors and represent risk factors for each another. Cardiac remodeling has been shown to be abnormally altered in patients with a high risk for preeclampsia in the first trimester.
Hyperspectral imaging has emerged as a potentially valuable technique for assessing peripheral microcirculation and tissue perfusion in a non-invasive and contactless manner. This imaging modality captures detailed hemodynamic data by visualizing parameters such as capillary hemoglobin oxygen saturation, tissue hemoglobin distribution, and relative tissue water content. Hyperspectral imaging has not yet been studied as predictive tool for preeclampsia before.
Given the well-documented preeclampsia-related vascular changes, the investigators suggest hyperspectral analysis as a valuable tool to predict preeclampsia. By identifying early subtle changes in microcirculatory perfusion, this method could enhance early detection and enable individualized care strategies for women at risk of developing preeclampsia.
Recently, theresearch team has explored the utility of the Endothelial Activation and Stress Index (EASIX) as a potential prognostic marker in preeclampsia. EASIX is calculated based on lactate dehydrogenase, platelet count, and creatinine and reflects systemic stress and endothelial injury, its specific relationship to microvascular health and endothelial function in pregnancy remains to be elucidated. EASIX levels were significantly increased in patients with adverse maternal and perinatal outcomes and were associated with the remaining time until delivery. The investigators hypothesize that impaired microcirculatory flow may promote pathological interactions between platelets and endothelial cells-leading to cellular damage (reflected in elevated LDH), platelet depletion via activation and microembolism, and renal impairment.
The HIPPA study (Systematic Evaluation of Hyperspectral Analysis for Prediction of Preeclampsia) is the first prospective investigation to evaluate the use of hyperspectral imaging for the prediction of preeclampsia in the first and second trimester. This study aims to assess whether the hyperspectral imaging correlates with biochemical indicators such as EASIX or markers of endothelial dysfunction. The secondary objective is to evaluate the association of hyperspectral imaging and-adverse maternal and perinatal outcomes.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 1,430 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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women scheduled for a routine ultrasound scan in first or second trimester
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Exclusion Criteria:
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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.
patients scheduled for routine first trimester ultrasound assessment
patients scheduled for routine anomaly scan in second trimester
Number of patients with Preeclampsia
Time frame: up to one week after delivery
Risk ratio of the preeclampsia screening
Time frame: baseline
Number of patients with an adverse maternal event
Time frame: up to one week after delivery
Number of patients with an adverse perinatal event
Time frame: up to one week after delivery
Plan to share: Undecided
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