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RecruitingNCT07106294HIPPAUpdated Sep 4, 2026

Hyperspectral Imaging for Prediction of Preeclampsia

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

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,430
Ages
18 Years and older
Sex
Female
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Preeclampsia (PE) Risk
  • Preeclampsia

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Keywords

  • preeclampsia
  • hyperspectral imaging
  • EASIX
  • endothelial dysfunction
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In context

Pre-Eclampsia

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 →

Lead sponsor

Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

women scheduled for a routine ultrasound scan in first or second trimester

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • singleton pregnancies
  • age ≥ 18 years
  • patient's ability to provide consent
  • written
  • women scheduled for a routine ultrasound scan in first or second trimester

Exclusion criteria

Exclusion Criteria:

  • lack of consent
  • language barrier
  • severe fetal chromosomal/genetic/structural anomalies known at study enrollment
  • smoking in the last two hours before measurement
  • diagnosis of preeclampsia at study enrollment
Terms in these criteria, in plain language(1)

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.

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,430 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • First trimester

    patients scheduled for routine first trimester ultrasound assessment

  • Second trimester

    patients scheduled for routine anomaly scan in second trimester

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What researchers measure

Primary outcomes

  1. Number of patients with Preeclampsia

    Time frame: up to one week after delivery

  2. Risk ratio of the preeclampsia screening

    Time frame: baseline

Secondary outcomes

  1. Number of patients with an adverse maternal event

    Time frame: up to one week after delivery

  2. Number of patients with an adverse perinatal event

    Time frame: up to one week after delivery

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07106294
Responsible party
Anna Scholz (Principal Investigator, Heidelberg University) — Principal investigator
First posted
Aug 6, 2025
Start date
Aug 21, 2025
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Anna S Dr. med. Anna Scholz, MD
Contact
anna.scholz@med.uni-heidelberg.de
+49 6221 56 32080
Alexandra von Au, MD
Contact
Dr. med. Alexandra von Au
principal investigator · University Heidelberg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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