Environmental Pollutants in Pregnancy - IoMumNEXT (IoMumNEXT)

Environmental Pollutants in Pregnancy - Exposure Assessment and Association With Early Childhood Development - IoMumNEXT

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Childhood, Neurodevelopment; Early Childhood, Anthropometry
• Intervention / Treatment: Other: Data collection; Other: Diagnostic Test: Urinary

Detailed Description

IoMumNEXT is a prospective observational study which will take advantage of our previous IoMum project - monitoring of iodine status in Portuguese pregnant women: impact of supplementation (Clinical Trials record: NCT04010708), a prospective observational study that has set up a cohort of 1155 pregnant women, living in the Porto and Lisbon Metropolitan Areas.

In a subsample of 199 pregnant women of this IoMum@Porto cohort it was already possible to conclude that:

1. 19 and 32% of women had urinary levels (first trimester) of lead (208Pb) and arsenic (75As), respectively above the corresponding reference values (> 4 microg / L for Pb and> 35 microg / L for As).
2. Maternal urinary Pb levels (first trimester) revealed a positive association with birth weight and length.
3. Maternal urinary levels of As (first trimester) revealed a positive association with head circumference at birth.
4. In a subsample of 69 pregnant women, 52% showed urinary 3-Phenoxybenzoic acid (3-PBA) levels above the detection level.

In addition to Pb, As and 3-PBA, the maternal urinary concentrations of other pollutants such as the elements lithium (7Li), cadmium (111Cd) and mercury (80Hg), and the pesticide metabolite trichloro-pyridinol (TCPY) will be analyzed. The continuity of this work will allow an important scientific advance, regarding the association between exposure to environmental pollutants and the physical and neurobehavioral development of children.

This proposal is in line with goal 3 (Health and well-being) of the United Nations Agenda 2030.

The study population will be composed of the pregnant women from the IoMum cohort as well as by their children born from this cohort. Maternal urine samples collected in the first trimester (T1) and third trimesters (T2) of pregnancy will be used, as well as urine samples from children collected between 3 and 6 years of age. Sociodemographic, lifestyle, anthropometric and health data will continue to be collected between 3 and 4 years of age (T3) and between 5 and 6 years of age (T4). Additionally, neurodevelopment will be assessed by Vineland adaptative behaviour scale at T3 and T4.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Elisa Keating, PhD; Phone Number: (+351) 225513624; Email: keating@med.up.pt
• Study Contact Backup: Name: Janete Santos, PhD; Phone Number: (+351) 225 513 600; Email: investigaclinica@med.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Faculty of Medicine (FMUP)
    • Contact: Elisa Keating, PhD; Phone Number: (+351) 225513624; Email: keating@med.up.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

Pregnancy complications

• Congenital malformations
• Gestational diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1st trimester maternal urinary concentration of iodine	Median urinary iodine concentrations at 1st trimester of gestation, in micrograms per liter	Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
3rd trimester maternal urinary concentration of environmental pollutants	Median urinary concentations of 3-PBA, TCPY, in micrograms per liter	Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)
3rd trimester maternal urinary concentration of oligoelements	Median urinary concentations of oligoelements including Pb, As, Cd, Li, Hg, in micrograms per liter	Between gestational weeks 37 and 40 plus 6 days (Timepoint 2)
Anthropometric measures of the children at birth, 1, 2 and 4 years - Weight	Weight information in grams or kilograms will be collected retrospectively from the clinical records or reported by the parents	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	Stature information in centimeters will be collected retrospectively from the clinical records or reported by the parents	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 and 2 years - Head circumference	Head circumference in centimeters will be collected retrospectively from the clinical records or reported by the parents	Birth, 1 and 2 years of age (retrospectively collected at the same moment, during the first phone call)
Apgar index	Apgar index at 1, 5 and 10 minutes	Birth (retrospectively collected)

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar Universitário São João, E.P.E. (CHUSJ); Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS); Rede de Investigação em Saúde (RISE), Laboratório Associado; Faculty of Medicine (FMUP)
• Investigators: Principal Investigator: Elisa Keating, PhD, Faculty of Medicine (FMUP)

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Childhood; Exposure; Anthropometry; Environmental Pollutants
• Other Study ID Numbers: IoMumNEXT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No