Using AI to predict early preeclampsia in pregnancy
Ruolo Del Microbiota Materno Sulla Risposta Immunitaria e Sul Metabolismo Nei Disordini Ipertensivi
This study is trying to see if the gut bacteria in pregnant women can help predict early signs of preeclampsia, especially in those at high risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Pieve Emanuele, Milan) |
| Trial ID | NCT06430398 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the maternal gut microbiota in women with two distinct phenotypes of preeclampsia: placental and metabolic. By characterizing the gut microbiota, the study seeks to understand how these microbial communities may influence the development of preeclampsia and its associated complications. The research will involve high-risk pregnant women who are screened during their first trimester and will focus on identifying unique microbial patterns that could aid in early prediction and prevention strategies for preeclampsia.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with a singleton pregnancy who are identified as high-risk for preeclampsia during their first-trimester screening.
Not a fit: Patients with multiple pregnancies, major fetal anomalies, or severe health conditions such as HIV or immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and prevention of preeclampsia, potentially reducing maternal and fetal morbidity and mortality.
How similar studies have performed: While the role of gut microbiota in preeclampsia is an emerging area of research, this specific multiomic AI approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Pieve Emanuele, Milan
- Hunanitas University — Pieve Emanuele, Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.