Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults

Launched by ISTITUTO CLINICO HUMANITAS · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial, called the MATERNALLY study, is investigating how inflammation during pregnancy can affect the brain development of babies. Researchers believe that studying specific markers in the blood and behavior of newborns can help predict if they might develop neurodevelopmental disorders later on. By combining tests from mothers and a controlled animal model, the study aims to find early signs that could lead to better monitoring and treatment for affected children.

To participate in this study, women aged 18 to 40 who are pregnant and have a healthy body weight (BMI between 18 and 25) may be eligible. They should have no serious health issues or complications in their pregnancy, like diabetes or pre-eclampsia. Participants can expect to undergo tests that will help researchers learn more about the connection between maternal inflammation and child development. This study is currently recruiting, and it aims to provide valuable insights for healthcare providers working with newborns.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 40 years. BMI between 18 kg/m2 and 25 kg/m2. Negative remote medical history for chronic conditions (rheumatological, immunological, endocrinological).
• • Negative obstetric history for significant pathologies (pre-eclampsia, gestational diabetes, preterm birth).
• • Reassuring combined test
• Exclusion Criteria:
• • Pre-gestational diabetes
• • Multiple pregnancy
• • Threatened preterm labor and/or premature rupture of membranes
• • Pre-eclampsia
• • Intrauterine growth restriction (IUGR)
• • Fetal macrosomia (biometrics \>90th percentile)
• • Chromosomal syndromes, genetic conditions, or multiple fetal malformations or major fetal malformations
• • Withdrawal of informed consent
• • Smoking patients are not excluded from the study, nor are patients who develop gestational diabetes during pregnancy.