Search / Trial NCT06617650

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 26, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

The GenerationGemelli study is looking at how different environmental factors that mothers are exposed to before and during pregnancy can affect the health of their newborns and children. The researchers will enroll around 140 mothers who have had babies with certain health challenges, such as being born too small or too early, and 280 mothers with healthy full-term pregnancies each year starting in September 2022. They will collect detailed information through questionnaires and gather biological samples from both mothers and newborns, including blood and other fluids. This will help scientists understand how things like heavy metals or other stressors might impact both mother and baby health.

To participate in this study, mothers must have lived in Rome for at least two years and plan to give birth at a specific hospital. Eligible mothers include those who have had a late intrauterine growth restriction (meaning their baby is smaller than expected) or a preterm birth, as well as those who have had healthy full-term pregnancies. Participants can expect to be followed up at 12 and 24 months after their baby is born, during which the researchers will check on their child’s growth, health, and development. This study hopes to shed light on important factors affecting maternal and child health, ultimately contributing to better care and outcomes.

Gender

FEMALE

Eligibility 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, Italia, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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