RecruitingNCT06430398

A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy

Ruolo Del Microbiota Materno Sulla Risposta Immunitaria e Sul Metabolismo Nei Disordini Ipertensivi

Sponsor

Istituto Clinico Humanitas

Enrollment

600 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

Preeclampsia

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and validating an AI-based tool that uses multiple biological measurements (from blood tests and other biomarkers) to predict which pregnant women are at risk for preeclampsia — a dangerous pregnancy complication involving high blood pressure — as early as the first trimester. **You may be eligible if...** - You are over 18 years old - You are carrying a single baby - Your baby has a heartbeat at 11–13 weeks of pregnancy - You have been identified as either high-risk or low-risk for preeclampsia during first-trimester screening - You can provide written informed consent **You may NOT be eligible if...** - You are carrying multiple babies - Your baby has a major structural abnormality identified at 11–13 weeks - You are severely ill, have severe learning difficulties, or have severe psychiatric disorders - You are under 18 - You have HIV, hepatitis B, or hepatitis C - You have a history of leukemia or lymphoma - You have an immune deficiency condition - You have used steroids or immunosuppressants in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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