GenerationGemelli: Longitudinal Study for the Evaluation of the Maternal Exposome on the Health of the Newborn and Child (GenGem)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Maternal Exposure; Maternal Exposure During Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT06617650

4975

Details and patient eligibility

About

The study involves the establishment of a case-control study within a birth cohort. With approximately 4,000 annual deliveries, the aim is to enroll 140 cases (newborns with intrauterine growth restriction [IUGR] and premature birth) and 280 controls each year, starting from September 2022. A comprehensive questionnaire will be utilized to gather information about various types of maternal environmental exposures before and during pregnancy. Biological samples will be collected from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life. Laboratory examinations will include the measurement of heavy metals and essential elements, investigation of placental distress and fetal brain damage biomarkers, analysis of microbiota, and assessment of DNA methylation profiles. Clinical follow-up assessments will be conducted in both cases and controls at 12 and 24 months, during which anthropometric data, types of feeding with particular reference to breastfeeding and its duration, pediatric emergency room visits, hospitalizations, medication usage, known allergies, and neuropsychological development will be collected.

Enrollment: 140 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Being resident for at least two years in the city of Rome, Italy.
• Being assisted and giving birth at FPG (presumably referring to a specific hospital).
• Meeting the definition of case or control.

Definitions:

• Cases:

Women with single pregnancies diagnosed with late intrauterine growth restriction (≥32 weeks of gestational age), according to the definition of Gordjin et al., in the absence of structural and/or evident organ malformations.

Women with spontaneous preterm birth at less than 32+0 weeks of gestational age.

• Controls:

Full-term pregnant women (gestational age between 37+0 and 41+6 weeks) without intrauterine growth restriction or other structural and/or genetic disorders.