Actively Recruiting
Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia
Led by Heidelberg University · Updated on 2025-05-11
385
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Preeclampsia is a pregnancy-related condition marked by high blood pressure and multiple organ issues that can quickly lead to serious health risks for both mother and baby. This condition involves problems with the blood vessels and small blood flow, which may last for years after childbirth. Researchers are studying a new imaging method called hyperspectral imaging to see if it can help diagnose and predict outcomes in women with preeclampsia by assessing these small blood vessels and tissue blood flow. The study includes four groups: women with preeclampsia, women with high blood pressure during pregnancy but not preeclampsia, pregnant women with normal blood pressure, and healthy non-pregnant women. Hyperspectral imaging will be done at the start of the study and then every 1 to 2 days until delivery, plus two days post-delivery. During imaging, blood flow changes are tested by inflating a cuff on the arm. Blood samples will be taken at these times to measure markers related to blood vessel function and damage. Additional tests include microscopy under the tongue and ultrasound assessments of key arteries. Participants will be monitored until six months after delivery, with researchers observing the time until delivery and tracking any adverse events for mother and baby. They will also measure ongoing blood pressure issues, medication use, and hospital readmissions related to cardiovascular health. The study aims to link imaging and blood markers with pregnancy outcomes to improve care for women with preeclampsia.
CONDITIONS
Brief Title
Endothelial Dysfunction for Prognosis In Patients With preeClampSia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancies
- Age 18 years or older
- Ability to provide consent
- Written informed consent
You will not qualify if you...
- Lack of consent
- Language barrier
- Dark to very dark skin type
- Severe fetal chromosomal, genetic, or structural anomalies
- Laboratory changes in LDH, creatinine, or platelets due to other causes such as isolated thrombocytopenia or carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From study inclusion until delivery
Participants undergo hyperspectral imaging, blood sample collections, sublingual in vivo microscopy, and Doppler ultrasound to evaluate microcirculation and endothelial dysfunction markers.
Repeated visits every 1 to 2 days until delivery
Duration - Up to 6 months after delivery
Participants are monitored for maternal and perinatal outcomes, including cardiovascular health and adverse events, up to 6 months after delivery.
Follow-up visits on the first and second day after delivery and additional monitoring visits as needed
Trial Site Locations
Total: 1 location
1
Heidelberg University Hospital, Department of Gynecology and Obstetrics
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
D
Dr. med. Anna Scholz
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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