Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT06430398

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Hunanitas University

Pieve Emanuele, Milan, Italy, 20072

Actively Recruiting

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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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