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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
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 or low-risk during first-trimester screening for preeclampsia and fetal growth restriction
- Signed written informed consent
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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