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

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

Inclusion Criteria5

  • 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

Exclusion Criteria8

  • 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

Locations(1)

Hunanitas University

Pieve Emanuele, Milan, Italy

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NCT06430398


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