Hyperspectral Imaging for Prediction of Preeclampsia

NCT07106294 | Recruiting

• 1 other identifier: S-313/2025
• Study Type: observational
• Target: 1,430
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia (PE) Risk; Preeclampsia

Keywords

preeclampsia; hyperspectral imaging; EASIX; endothelial dysfunction

Outcome Measures

Primary Outcomes (2)

• Number of patients with Preeclampsia

  up to one week after delivery

• Risk ratio of the preeclampsia screening

  baseline

Secondary Outcomes (2)

• Number of patients with an adverse maternal event

  up to one week after delivery

• Number of patients with an adverse perinatal event

  up to one week after delivery

Study Arms (2)

First trimester

patients scheduled for routine first trimester ultrasound assessment

Second trimester

patients scheduled for routine anomaly scan in second trimester

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Heidelberg University Hospital, Department of Gynecology and Obstetrics

Heidelberg, 69120, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (serum) samples

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dr. med. Alexandra von Au

  University Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Dr. med. Anna Scholz, MD

CONTACT

+49 6221 56 32080; anna.scholz@med.uni-heidelberg.de

Alexandra von Au, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

DE (1)