A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy

NCT06430398 | Recruiting DMC

• 1 other identifier: 0011882
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Identification of Biomarkers for Predicting Clinical Phenotypes of Preeclampsia: Implications for Innovative Preventive Strategies and Future Therapeutic Targets

  Identifying biomarkers useful for predicting different clinical phenotypes of preeclampsia that could assist in innovative preventive strategies and/or future therapeutic targets.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Assessment of first trimester microbiota characteristics

  through study completion, an average of 1 year

• Assessment of first trimester metaboloma characteristics

  through study completion, an average of 1 year

• Assessment of first trimester immune system characteristics

  through study completion, an average of 1 year

Study Arms (2)

Case

Age \> 18 years Singleton pregnancy Live fetus at 11-13 weeks of pregnancy Women identified as high-risk during first-trimester screening for preeclampsia and fetal growth restriction

Control

Low-risk pregnancies at first-trimester screening for preeclampsia and fetal growth restriction, which will undergo physiological monitoring in subsequent follow-up visits until delivery (homogeneous control sample).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women identified as high risk for developing preeclampsia from the first trimester of pregnancy will be offered the opportunity to participate in the study. To obtain a control sample, an equal number (1:1 ratio) of pregnant women identified as low risk during the first-trimester screening for preeclampsia and fetal growth restriction, and who will present physiological check-ups in subsequent follow-up visits until delivery, will also be invited to participate. Recruitment of controls will follow an alternating principle: high risk-low risk-high risk-low risk. Patients will be followed up according to a defined schedule, varying depending on the underlying condition, while high-risk patients and controls will be seen once per trimester if the pregnancy remains uncomplicated.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Hunanitas University

Pieve Emanuele, Milan, 20072, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The protocol involves the analysis of maternal microbiota and metabolome from saliva and fecal samples, as well as blood samples collected from consenting women during scheduled obstetric visits conducted by the study's responsible physicians until delivery. At each visit, as per protocol, saliva and fecal samples will be collected and frozen at -80°C, and a 7 ml whole peripheral blood sample in EDTA will be collected and kept at room temperature. The blood will be centrifuged to separate plasma from the cellular fraction. The isolated plasma will be frozen at -80°C for subsequent metabolomic and microbiota analyses, while the cells will be resuspended in phosphate-buffered saline (PBS) in equal volume to the isolated plasma.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

IT (1)