Preeclampsia (PE) RiskHIPPANCT07106294
Hyperspectral Imaging for Prediction of Preeclampsia
An observational study of Preeclampsia (PE) Risk and Preeclampsia, run by Heidelberg University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia (PE) Risk, Preeclampsia
- How many people
- 1,430 participants
- Where
- 1 siteGermany
- Study dates
- 21 Aug 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women scheduled for a routine ultrasound scan in first or second trimester
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra von Au, MD contact
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University Hospital, Department of Gynecology and Obstetrics
Heidelberg, 69120
Dr. med. Anna Scholz, +49 6221 56 32080, anna.scholz@med.uni-heidelberg.de
Dr. med. Alexandra von Au, alexandra.vonau@med.uni-heidelberg.de
About this study
Official title: Systematic Evaluation of Hyperspectral Analysis as a Predictive Marker of Preeclampsia
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.
- Conditions
- Preeclampsia (PE) Risk, Preeclampsia
- Keywords
- preeclampsia, hyperspectral imaging, EASIX, endothelial dysfunction
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First trimester | patients scheduled for routine first trimester ultrasound assessment | |
| Second trimester | patients scheduled for routine anomaly scan in second trimester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Preeclampsia
Measured: up to one week after delivery
Risk ratio of the preeclampsia screening
Measured: baseline
Secondary outcomes (2)
Number of patients with an adverse maternal event
Measured: up to one week after delivery
Number of patients with an adverse perinatal event
Measured: up to one week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start21 Aug 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE) RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Scholz, Heidelberg University
- Investigators
- Dr. med. Alexandra von Au, Principal investigator, University Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106294
- Sponsor's protocol ID
- S-313/2025
- Acronym
- HIPPA
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Evaluation of Hyperspectral Analysis as a Predictive Marker of Preeclampsia
- ClinicalTrials.gov ID
- NCT07106294
- Acronym / sponsor ID
- HIPPA / S-313/2025
- Conditions
- Preeclampsia (PE) Risk, Preeclampsia
- Keywords
- preeclampsia, hyperspectral imaging, EASIX, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,430 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First trimester | – | –patients scheduled for routine first trimester ultrasound assessment |
| Second trimester | – | –patients scheduled for routine anomaly scan in second trimester |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women scheduled for a routine ultrasound scan in first or second trimester
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with Preeclampsia
Time frame: up to one week after delivery
Risk ratio of the preeclampsia screening
Time frame: baseline
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra von Au, MD contact
Dr. med. Alexandra von Au principal investigator
University Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE) Risk and Preeclampsia, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna S Dr. med. Anna Scholz, MD (+49 6221 56 32080, anna.scholz@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Preeclampsia (time frame: up to one week after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.