Hyperspectral Imaging for Prediction of Preeclampsia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHeidelberg University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

singleton pregnancies

age ≥ 18 years

patient's ability to provide consent

written informed consent

Disqualifiers

lack of consent

language barrier

severe fetal chromosomal/genetic/structural anomalies known at study enrollment

smoking in the last two hours before measurement

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,430 Participants
are grouped into 2 trial groups
Group A: First trimester
Group B: Second trimester

Trial outcomes

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

Other outcomes

Sponsors and contacts

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