Environmental Pollutants in Pregnancy - IoMumNEXT

NCT06226311 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2024-01-26

No results posted yet for this study

Summary

Globally 12.6 million people, including 1.7 million children under the age of 5, die each year from environmental-related illnesses. Prenatal exposure to environmental chemical pollutants has been associated with perinatal mortality, prematurity, low birth weight, congenital malformations, neurobehavioral function disorder and metabolic disorders. This project aims: a) to evaluate exposure to environmental pollutants during pregnancy; and, b) to study the association of this exposure with anthropometry and neurodevelopment of the offspring, up to 6 years of age. This study will be based on a population of 1000 pregnant women whose recruitment has already started under the IoMum project (clinical trials #NCT04010708), previously approved by Ethics Commitee of Centro Hospitalar e Universitário São João/Faculdade de Medicina da Universidade do Porto (#292-17). Maternal urine samples collected in the 1st and 3rd trimesters of pregnancy will be used. Maternal urinary concentrations of toxic metals and pesticide metabolites will be determined and neurodevelopmental outcomes will be evaluated as well as anthropometric parameters of children from birth to 6 years of age. The results of this project will contribute to the characterization of the exposure of Portuguese pregnant women to environmental pollutants as well as to the knowledge on the association between isolated or cumulative exposure to these pollutants and the health of the offspring.

Conditions

  • Early Childhood, Neurodevelopment
  • Early Childhood, Anthropometry

Interventions

OTHER

Data collection

Collection of sociodemographic, lifestyle and health data; Child anthropometry (weight, height and head circumference) at the ages of 3-4 and 5-6 years Child neurodevelopment scores at the ages of 3-4 and 5-6 years

OTHER

Diagnostic Test: Urinary

Trichloro-pyridinol (TCPy) and 3-phenoxybenzoic acid (3-PBA) Environemental oligoelements including Lithium (7Li), Arsenic (75As), Cadmium (111Cd), Lead (208Pb) and Mercury (80Hg)

Sponsors & Collaborators

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER
  • Centro de Investigação em Tecnologias e Serviços de Saúde

    collaborator OTHER
  • Rede de Investigação em Saúde

    collaborator OTHER
  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Elisa Keating, PhD · Universidade do Porto

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-09-01
Completion
2025-12-01

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226311 on ClinicalTrials.gov