Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

NCT03084445 | Active Not Recruiting

• 1 other identifier: 12/12
• Study Type: observational
• Target: 2,394
• Locations: 1 country
• Sites: 3

Brief Summary

Objectives and hypothesis The scale and diversity of chemicals in worldwide use today is vast. Many of these chemicals are released into the environment where they are found in air, water, soil, house dust, and in the food supply, resulting in exposure to humans. Characterizing the extent of exposure and the effects of exposure in vulnerable populations, such as pregnant women and children, is of the utmost importance as the chemical structure of many of these compounds resembles hormones such as estrogen, testosterone and thyroid hormone, affect neurodevelopment and other health effects. Here, we focus on few classes of compounds: heavy metals, volatile organic compounds (VOCs), brominated flame retardants (PBDEs) and phthalates. We will characterize the extent of exposure to pregnant women and their infants in Israel, where biomonitoring studies in the general population are scarce. We will also examine selected outcomes in pregnant women and their offspring in relation to these compounds, and to establish a biorepository for further studies. Specific Aims:

1. 1.To assess Heavy metals, VOCs, PBDEs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations.
2. 2.To examine associations between exposure to heavy metals, VOCs, PBDEs and phthalates and (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted for gestational age, ponderal index, head circumference adjusted for gestational age), and (c) cryptorchidism incidence, (d) maternal and infant thyroid function.
3. 3.To establish a bio repository of these media for future studies and to establish follow up methods for this cohort to later assess development and growth in the infants, toddlers and children.

Conditions

Exposure to Environmental Pollution

Keywords

Brominated Flame Retardants (BFRs); Phthalates; pregnant women; newborn; Heavy Metals; Volatile Organic Compounds

Outcome Measures

Primary Outcomes (1)

• Measuring envinromental polutants, including heavy metals, VOCs, PBDEs and phthalates levels in collected samples

  assessment of BFRs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations

  48 months after end of specimens collection

Secondary Outcomes (1)

• associations between exposure to nvinromental polutants, including heavy metals, VOCs, PBDEs and phthalates and few maternal and infant pregnancy and birth parameters and endocrine functions

  48 months after end of specimens collection

Other Outcomes (1)

• To establish a bio repository of these media for future studies

  15 years after end of specimens collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women and their partners attenting delivery room

You may qualify if:

• Israeli Arabs, Jews from Russia, Jews from Ethiopia, Jews with an Ashkenazic background and Jews with a Sephardic background

You may not qualify if:

• refuse to take part in the study

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (3)

Rambam Medical Center

Haifa, Israel

Location

Lis Medical Center

Tel Aviv, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, red blood cells, urine, breast milk, meconium

Study Officials

• Mati Berkovitch, Prof.

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: March 21, 2017
• Study Start: September 1, 2013
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

IL (3)