Evaluating how maternal environmental exposures affect newborn and child health
GenerationGemelli: Longitudinal Study for the Evaluation of the Maternal Exposome on the Health of the Newborn and Child
This study is trying to see how things in the environment that mothers are exposed to before and during pregnancy affect the health of their newborns and children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Italia) |
| Trial ID | NCT06617650 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a case-control framework within a birth cohort to assess the impact of maternal environmental exposures on newborn health. Each year, approximately 140 cases of newborns with intrauterine growth restriction and premature birth will be enrolled alongside 280 controls. Comprehensive questionnaires will collect data on maternal exposures before and during pregnancy, while biological samples will be taken from mothers and newborns for laboratory analysis. Follow-up assessments will occur at 12 and 24 months to evaluate long-term health outcomes.
Who should consider this trial
Good fit: Ideal candidates include pregnant women residing in Rome who are giving birth at the designated hospital and meet the criteria for either cases or controls.
Not a fit: Patients who do not reside in Rome or do not meet the specific case or control definitions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how maternal exposures influence the health of newborns and children, potentially guiding preventive measures.
How similar studies have performed: While similar studies have explored maternal exposures, this specific approach focusing on a comprehensive set of biological samples and longitudinal follow-up is relatively novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Roma, Italia
- Dipartimento Universitario di Scienze della Vita e Sanità Pubblica — Roma, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Stefania Boccia
- Email: stefania.Boccia@unicatt.it
- Phone: 0630154396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.