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临床试验/NCT03084445
NCT03084445进行中(未招募)不适用

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

Assaf-Harofeh Medical Center3 个研究点 分布在 1 个国家目标入组 2,394 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,394
试验地点
3
主要终点
Measuring envinromental polutants, including heavy metals, VOCs, PBDEs and phthalates levels in collected samples

研究概览

简要总结

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. 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. 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. 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.

Patients and Methods:

Patients will be recruited from three delivery rooms in Israel: "Assaf Harofeh Medical Center" , "Lis (Sorasky) Medical Center" and "Rambam Medical Center", all together with around 21,000 births annually, representing all sub-populations in Israel. 500 mother-father-infant trios (for a total of 4500) will be recruited.

When arriving to the delivery room, after signing the informed consent, blood and urine will be withdrawn from the mothers and fathers for Heavy metals, VOCs, PBDEs and phthalates levels. At the same time thyroid function tests will also be taken from the mothers. After delivery, cord blood will be taken, as well as meconium from the neonate. Hair, nails and Breastmilk will also be collected. From the mothers The samples will be analyzed for heavy metals, VOCs, PBDEs and phthalates. During their stay at the hospital, mothers and fathers will fill out a standardized questionnaire regarding life style factors, background information, and exposure opportunities. Detailed information on family history, previous and present pregnancy, method of delivery, perinatal complications, and pregnancy outcome will be recorded from the medical files.

Expected contribution to environmental health in Israel:

This will be the first data on sub-populations exposure to Heavy metals, VOCs, PBDEs and phthalates in Israel. Neonatal meconium levels will provide important information on magnitude of exposure during the last months of pregnancy, and, thus, will provide insights into the bioaccumulative nature of these Heavy metals, VOCs, PBDEs and phthalates during early stages of human development, important data for future risk assessments. Our comprehensive approach will provide detailed information on the status of each subject. Such novel knowledge would also lead to the development of preventive and counseling strategies for men and women with high BFR and phthalates exposure in order to minimize the risks of adverse outcomes. Knowledge transfer strategies are essential in order that the general public, health professionals, scientists and policy/law regulators have the appropriate knowledge on which to base their understandings and recommendations for the future. In this way, the knowledge that is generated will facilitate the development of prevention strategies to minimize health risks of Israel population.

详细描述

Objectives and hypothesis The scale and diversity of chemicals in worldwide use today is vast, ranging from pharmaceuticals and food products, to plastics, gasoline, and semiconductor chips. Many of these chemicals are released into the environment where they are found in air, water, soil, in 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 resemble 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., and will characterize the extent of exposure to pregnant women and their infants in Israel, where biomonitoring studies in the general population are scarce. We also propose to examine selected outcomes in pregnant women and their offspring in relation to these compounds, and to establish a biorepository for further studies.

BTEX (Benzene, Toluene, Ethylbenzene, Xylene):

Volatile organic compounds (VOCs) are compounds with low boiling points; VOC exposures originate from numerous natural and anthropogenic sources such as cleaning products, paints, solvents, personal care products, automotive exhaust, and tobacco smoke. Exposure to certain VOCs may increase the risk for birth defects, neurocognitive impairment, asthma, and cancer. The known VOC metabolites are acrolein, acrylamide, acrylonitrile, benzene, 1-bromopropane, 1,3-butadiene, carbon disulfide, crotonaldehyde, cyanide, N,N-dimethylformamide, ethylbenzene, ethylene oxide, propylene oxide, styrene, tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and xylene exposures. Benzene, toluene, ethylbenzene and xylene isomers (BTEX), aromatic hydrocarbons, are part of VOC metabolites that play a major role in industries and air pollution 1.

Prena¬tal exposure to air pollution (contains BTEX) might be associated with adverse pregnancy outcomes, including intrauterine growth restriction (IUGR), low birth weight (LBW), preterm birth (PTB), and intrauter¬ine mortality. Exposure to BTEX chemicals has been associated with negative impacts on sperm quantity and quality. Benzene and toluene exposure have been associated with abnormal menstrual cycle. Direct adverse effects of BTEX chemicals have been observed on ovarian cell apoptosis, proliferation, and hormone release in animal ovarian cells. Exposures to benzene and toluene, commonly used and produced by unconventional oil and gas (UOG) operations, have been associated with increased risks for miscarriage 2.

Xylene is an environmental pollutant. It is also used in dyes, paints, polishes, medical technology and different industries as a solvent. Human life is surrounded by a wide range of VOCs, including xylene causing harmful health effects xylene exposure occurs through breath, eye, oral, and dermal route. Xylene is mainly metabolized in the liver via oxidation of methyl groups, followed by conjugation with glycine to yield hippuric acid, which is excreted through urine. High amount and dose of xylene may harm the liver. Prolonged exposure to xylene may cause a multiorgan damages such as: toxicity to nervous, reproductive, immune, hepatic and respiratory systems. Furthermore, xylene reduces reproductive hormones in women and cause male infertility. Studies have reported the subsequent effects in experimental animals: deformities in fetus skeletal, increased interruption in bone formation, redness and blood in fetus organs, and reduced fetus weight3.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • refuse to take part in the study

结局指标

主要结局

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

时间窗: 48 months after end of specimens collection

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

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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