Hyperspectral imaging to predict preeclampsia risk
Systematic Evaluation of Hyperspectral Analysis as a Predictive Marker of Preeclampsia
Heidelberg University · NCT07106294
This study will test whether a non-contact camera method called hyperspectral imaging can spot early microcirculation changes and help predict which pregnant people will develop preeclampsia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1430 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Heidelberg University (other) |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT07106294 on ClinicalTrials.gov |
What this trial studies
The HIPPA project is a prospective observational study at Heidelberg University Hospital that uses contact-free hyperspectral imaging to visualize peripheral microcirculation and tissue perfusion in pregnant people. Participants with singleton pregnancies who are ≥18 and attending routine first- or second-trimester ultrasound will undergo hyperspectral imaging to capture parameters like capillary hemoglobin oxygen saturation, tissue hemoglobin distribution, and relative tissue water content. Clinical data and pregnancy outcomes will be followed to determine whether imaging patterns precede or predict the later development of preeclampsia. Imaging is non-invasive and measurements will be correlated with standard clinical assessments and outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) with singleton pregnancies who can give written consent and are scheduled for a routine first- or second-trimester ultrasound are ideal candidates.
Not a fit: People already diagnosed with preeclampsia at enrollment, those with severe known fetal chromosomal or structural anomalies, or individuals unable to give informed consent or with language barriers are unlikely to benefit from this predictive imaging.
Why it matters
Potential benefit: If successful, this approach could allow earlier identification of people at high risk for preeclampsia so they can receive closer monitoring and preventive care.
How similar studies have performed: Hyperspectral imaging has shown promise in other medical fields for assessing microcirculation, but its use for predicting preeclampsia is novel and has not been systematically proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg
- Heidelberg University Hospital, Department of Gynecology and Obstetrics — Heidelberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Dr. med. Alexandra von Au — University Heidelberg
- Study coordinator: Anna S Dr. med. Anna Scholz, MD
- Email: anna.scholz@med.uni-heidelberg.de
- Phone: +49 6221 56 32080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preeclampsia Risk, Preeclampsia, preeclampsia, hyperspectral imaging, EASIX, endothelial dysfunction