Identifying biomarkers for neurodevelopmental disorders linked to inflammation during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify predictive biomarkers for neurodevelopmental disorders in children whose mothers experienced inflammation during pregnancy. It will involve 300 pregnant women and their children, with biological samples collected at various stages of pregnancy to assess immune responses. The study will also utilize a controlled mouse model to explore the molecular mechanisms connecting maternal inflammation to altered brain development. The integration of these approaches seeks to provide early indicators and potential intervention strategies for affected children.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aoup
  Pisa, Pi, Italy Recruiting

Study contacts

• Study coordinator: Antonella Pisano, Dr.
• Email: contratti.ricerca@humanitas.it
• Phone: +39 02 82244501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.