Environmental Pollutants in Pregnancy - Exposure Assessment and Association With Early Childhood Development - IoMumNEXT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Anthropometric measurements of children - Height
研究概览
简要总结
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.
详细描述
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:
- 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).
- Maternal urinary Pb levels (first trimester) revealed a positive association with birth weight and length.
- Maternal urinary levels of As (first trimester) revealed a positive association with head circumference at birth.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnancy complications
- •Congenital malformations
- •Gestational diabetes
结局指标
主要结局
Anthropometric measurements of children - Height
时间窗: 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)
Information on the height (in centimeters) of children aged between 3-4 and 5-6 years will be recorded
1st trimester maternal urinary concentrations of oligoelements
时间窗: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
Median urinary concentations of Pb, As, Cd, Li, Hg in micrograms per liter
Anthropometric measurements of children - Weight
时间窗: 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)
Information n the weight (in kilograms) of children aged between 3-4 and 5-6 years will be recorded
Neurodevelopment scores of children
时间窗: 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
Communication, daily life activities, socialization and motor skills will be assessed using the Vineland Adaptive Behavior Scale
1st trimester maternal urinary concentrations of environmental pollutants
时间窗: Between gestational weeks 10 and 13 plus 6 days (Timepoint 1)
Median urinary concentations of 3-PBA, TCPY in micrograms per liter
次要结局
- Apgar index(Birth (retrospectively collected))
- 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 - Height(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 - 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 and 2 years - Head circumference(Birth, 1 and 2 years of age (retrospectively collected at the same moment, during the first phone call))
- 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))