Endothelial Dysfunction for Prognosis In Patients With preeClampSia

NCT06912477 | Recruiting

• 1 other identifier: S-457/2024
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before. This EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.

Conditions

Preeclampsia (PE); Hypertensive Disorder of Pregnancy

Keywords

preeclampsia; hyperspectral imaging; endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• Time Until Delivery

  Time period between date of study inclusion (diagnostic tests) to delivery

  observation period until 6 months after delivery

Secondary Outcomes (6)

• maternal adverse event

  observation period until 6 months after delivery

• perinatal adverse event

  observation period until 6 months after delivery

• maternal cardiovascular outcome: persistence of hypertension

  observation period until 6 months after delivery

• maternal cardiovascular outcome: blood pressure

  observation period until 6 months after delivery

• maternal cardiovascular outcome: antihypertensive medication

  observation period until 6 months after delivery

Study Arms (4)

Preeclampsia

patients with diagnosis of preeclampsia according to definitions by the International Society for the Study of Hypertension in Pregnancy (n=110)

Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction

Pregnancy induced Hypertension and chronic Hypertension

patients with hypertension in pregnancy without fulfilling criteria of preeclampsia (n=110)

Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction

Normotensive pregnant control group

normotensive pregnancies (n=110)

Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction

Non-pregnant control group

normotensive, non-pregnant women (n=55)

Diagnostic Test: Hyperspectral imaging; Diagnostic Test: Further markers of endothelial dysfunction

Interventions

Hyperspectral imaging DIAGNOSTIC_TEST

Hyperspectral imaging will be performed at study inclusion and will be repeated longitudinally every 1-2 days until delivery and on the first and second day after delivery. After a baseline measurement, a blood pressure cuff is inflated on the upper arm to 50 mmHg above the systolic blood pressure for 5 minutes, and then the hyperspectral imaging measurement is repeated. Blood samples are collected at study inclusion and on the first and second day after delivery and are processed within the Department of Gynecology and Obstetrics of the Heidelberg University Hospital.

Non-pregnant control group; Normotensive pregnant control group; Preeclampsia; Pregnancy induced Hypertension and chronic Hypertension

Further markers of endothelial dysfunction DIAGNOSTIC_TEST

At study inclusion: 1. blood samples will be collected for the measurement of EASIX and cardiac/endothelial markers; 2. sublingual in vivo microscopy will be performed (requires about 20 minutes and can be compared to a sublingual temperature measurement); 3. Doppler ultrasound will be performed to evaluate uterine and ophthalmic arteries. Blood samples will also be collected at the first and second day after delivery.

Non-pregnant control group; Normotensive pregnant control group; Preeclampsia; Pregnancy induced Hypertension and chronic Hypertension

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

Patients who are admitted to the Department of obstetrics at Heidelberg University Hospital

You may qualify if:

• singleton pregnancies
• Age ≥ 18 years
• Patient's ability to provide consent
• written informed consent

You may not qualify if:

• Lack of consent
• Language barrier
• Dark to very dark skin type
• Severe fetal chromosomal/genetic/structural anomalies
• Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma)

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 samples

MeSH Terms

Conditions

Pre-Eclampsia; Toxemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. med. Alexandra von Au

  University Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. med. Anna Scholz

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Anna Scholz

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 4, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

DE (1)