Environmental Pollutants in Pregnancy - IoMumNEXT

NCT06226311 | Unknown

• 1 other identifier: IoMumNEXT
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pregnancy; Childhood; Exposure; Environmental Pollutants; Anthropometry

Outcome Measures

Primary Outcomes (5)

• Anthropometric measurements of children - Weight

  Information n the weight (in kilograms) of children aged between 3-4 and 5-6 years will be recorded

  The information will be collected at baseline by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)

• Anthropometric measurements of children - Height

  Information on the height (in centimeters) of children aged between 3-4 and 5-6 years will be recorded

  The information will be at baseline collected by telephone contact (3-4 years of age) with parents or legal representatives or by direct, in person, measurement (5-6 years of age)

• Neurodevelopment scores of children

  Communication, daily life activities, socialization and motor skills will be assessed using the Vineland Adaptive Behavior Scale

  At 3-4 and 5-6 years old of the children, parents will answer a questionnaire regarding daily living, social, communication and motor skills adjusetd to the specific age group, at baseline

• 1st trimester maternal urinary concentrations of environmental pollutants

  Median urinary concentations of 3-PBA, TCPY in micrograms per liter

  Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)

• 1st trimester maternal urinary concentrations of oligoelements

  Median urinary concentations of Pb, As, Cd, Li, Hg in micrograms per liter

  Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)

Secondary Outcomes (7)

• 1st trimester maternal urinary concentration of iodine

  Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)

• 3rd trimester maternal urinary concentration of environmental pollutants

  Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)

• 3rd trimester maternal urinary concentration of oligoelements

  Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)

• Anthropometric measures of the children at birth, 1, 2 and 4 years - Weight

  Birth, 1, 2 and 4 years of age (retrospectively collected at the same moment, during the first phone call)

• Anthropometric measures of the children at birth, 1, 2 and 4 years - Height

  Birth, 1, 2 and 4 years of age (retrospectively collected at the same moment, during the first phone call)

Study Arms (1)

Children of IoMum pregnants cohort

IoMum participants without congenital malformations or gestational diabetes, with a singleton pregnancy with live birth, who provided contact and a T1 urine sample, will be invited to participate under signed informed consent.

Other: Data collection; Other: Diagnostic Test: Urinary

Interventions

Data collection OTHER

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

Children of IoMum pregnants cohort

Diagnostic Test: Urinary OTHER

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

Children of IoMum pregnants cohort

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be based on the 1155 pregnant women from the IoMum cohort, who have already been recruited at the Centro Hospitalar Universitário de São João (CHUSJ) and at CUF Descobertas Hospital (CUFD), Lisbon, in the 1st trimester ultrasound scan, as well as by the children born in this cohort.

You may qualify if:

• Have had single live birth
• Have provided contact and a urine sample T1
• Have provided consent to participate at T1
• Have provided consent to participate at T3

You may not qualify if:

• Pregnancy complications
• Congenital malformations
• Gestational diabetes

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (1)

Faculty of Medicine (FMUP)

Porto, 4200-319, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elisa Keating, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Keating, PhD

CONTACT

(+351) 225513624; keating@med.up.pt

Janete Santos, PhD

CONTACT

(+351) 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 26, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 26, 2024

Record last verified: 2023-10

Locations

PT (1)