Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID06430398

A Novel Multiomic AI Approach for Early Prediction of Preeclampsia in Pregnancy Using Maternal Gut Microbiota and Immune Response

Led by Istituto Clinico Humanitas · Updated on 2024-05-28

600

Participants Needed

1

Research Sites

30 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 serious condition affecting 3-8% of pregnancies and is a leading cause of illness and death for mothers and babies. It involves high blood pressure and organ damage or growth problems in the fetus. There are two main types: placental PE, linked to problems with the placenta and early pregnancy complications, and metabolic PE, related to maternal metabolic issues like obesity and inflammation. Recent research suggests that changes in the mother's gut bacteria may influence the immune system and play a role in PE development. This study aims to better understand the gut microbiota differences in these two PE types to improve prediction and prevention. The study observes pregnant women from 11 to 13 weeks gestation who are either at high risk or low risk for developing PE based on early screening. Participants include women over 18 with a single pregnancy and a live fetus. Researchers will monitor maternal gut microbiota, metabolic markers, and immune system characteristics during the first trimester without providing any treatments. The study includes a control group of low-risk pregnancies followed throughout pregnancy to compare with the high-risk group. Participants will undergo assessments including gut microbiota analysis, metabolic profiling, and immune function tests during early pregnancy. Researchers will track outcomes related to PE development and fetal growth restriction, aiming to identify biomarkers that could help predict PE types. The study lasts about one year per participant, with data collected during pregnancy and after delivery. This observational study does not involve treatment but focuses on collecting detailed biological and clinical information to improve understanding of PE.

CONDITIONS

Brief 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 or low-risk during first-trimester screening for preeclampsia and fetal growth restriction
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Multiple pregnancy
  • Pregnancy with major fetal anomalies detected at 11-13 weeks gestation
  • Unconscious or severely ill women, women with learning difficulties, or severe psychiatric disorders
  • Age under 18 years
  • Women who have not signed informed consent
  • Women with HIV, HBV, or HCV infection
  • History of leukemia or lymphoma
  • Immunodeficiency
  • Use of corticosteroids or immunosuppressants in past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to delivery (approximately 7 to 8 months)

Participants who are identified as high-risk or low-risk during first-trimester screening are observed throughout their pregnancy to assess maternal gut microbiota, immune response, and metabolomic characteristics related to preeclampsia phenotypes.

Follow-up visits during pregnancy as scheduled by routine clinical care

Trial Site Locations

Total: 1 location

1

Hunanitas University

Pieve Emanuele, Milan, Italy, 20072

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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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