Hyperspectral Imaging for Prediction of Preeclampsia

NCT ID: NCT07106294

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1430 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2027-07-01

Brief 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.

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.

Conditions

Preeclampsia (PE) Risk; Preeclampsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First trimester

patients scheduled for routine first trimester ultrasound assessment

No interventions assigned to this group

Second trimester

patients scheduled for routine anomaly scan in second trimester

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Anna Scholz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. med. Alexandra von Au

Role: PRINCIPAL_INVESTIGATOR

University Heidelberg

Locations

Heidelberg University Hospital, Department of Gynecology and Obstetrics

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Anna S Dr. med. Anna Scholz, MD

Role: CONTACT

anna.scholz@med.uni-heidelberg.de

+49 6221 56 32080

Alexandra von Au, MD

Role: CONTACT

Facility Contacts

Dr. med. Anna Scholz

Role: primary

anna.scholz@med.uni-heidelberg.de

+49 6221 56 32080

Dr. med. Alexandra von Au

Role: backup

alexandra.vonau@med.uni-heidelberg.de

Other Identifiers

S-313/2025

Identifier Type: -

Identifier Source: org_study_id