Actively Recruiting
A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy
Led by Istituto Clinico Humanitas · Updated on 2024-05-28
600
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
I
Istituto Clinico Humanitas
Lead Sponsor
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsor
AI-Summary
What this Trial Is About
Preeclampsia (PE) is a leading cause of maternal-fetal morbidity and mortality, affecting 3-8% of pregnancies and causing over 76,000 maternal deaths annually. PE is characterized by high blood pressure and proteinuria or organ damage/intrauterine growth restriction (IUGR). There are two phenotypes: placental PE, caused by abnormal trophoblast invasion, often leading to early pregnancy complications and IUGR, and metabolic PE, associated with maternal metabolic issues like visceral obesity and metabolic syndrome, leading to low-grade inflammation and insulin resistance. Recent research highlights the role of maternal gut microbiota in these conditions, suggesting that gut dysbiosis-altered microbial balance-can influence systemic immune responses and contribute to PE. This study aims to characterize the maternal gut microbiota in the two PE phenotypes to better understand their distinct etiologies and improve prediction and prevention strategies.
CONDITIONS
Official Title
A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Singleton pregnancy
- Live fetus at 11-13 weeks of gestation
- Women identified as high-risk during first-trimester screening for preeclampsia and subsequent low risk
- Written Informed Consent
You will not qualify if you...
- Multiple pregnancy
- Pregnancy complicated by major fetal anomalies identified during the evaluation at 11-13 weeks gestation
- Unconscious or severely ill women, women with learning difficulties, and severe psychiatric disorders
- Age <18 years
- Women who will not have signed the informed consent for the study
- Women with HIV, HBV, HCV infection
- Women with a history of leukemia and lymphoma
- Women with immunodeficiency
- Women who have used corticosteroids or other immunosuppressants in the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunanitas University
Pieve Emanuele, Milan, Italy, 20072
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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