RecruitingNCT06852703

Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults

Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL


Sponsor

Istituto Clinico Humanitas

Enrollment

300 participants

Start Date

Sep 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Inflammation during pregnancy represents an important risk factor for the development of neuropsychiatric disorders in the offspring. Despite clear epidemiological data supporting this association, translational studies aimed at identifying early predictive biomarkers and possible interventional strategies for this pathological condition are still missing. The MATERNALLY proposal aims to assess in a large patient cohort a novel multiparametric approach for the identification of predictive postnatal behavioral and circulating biomarkers. In parallel, a controlled mouse model for maternal immune activation will be exploited to understand the basic molecular mechanism that links inflammation with aberrant neural circuit formation and to unveil possible therapeutic targets. The integration of the two approaches will allow identifying early predictive biomarkers and proof of principle interventional strategies for this condition of high practical relevance to the neonatologist community


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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Interventions

OTHERInfection during pregnancy

any bacterial or viral infection acquired during pregnancy


Locations(1)

AOUP

Pisa, PI, Italy

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NCT06852703


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