NCT06430398 A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy
| NCT ID | NCT06430398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-03-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT06430398 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06430398 currently recruiting?
Yes, NCT06430398 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Clinico Humanitas to inquire about joining.
Where is the NCT06430398 trial being conducted?
This trial is being conducted at Pieve Emanuele, Italy.
Who is sponsoring the NCT06430398 clinical trial?
NCT06430398 is sponsored by Istituto Clinico Humanitas. The trial plans to enroll 600 participants.