Arsenic Contaminated Water Consumption & Spontaneous Pregnancy Loss in Romania

砷污染水消耗量

• 批准号: 8176413
• 负责人: Michael S Bloom
• 金额: $ 7.8万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT ALBANY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-29 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8176413
• 关键词: Achievement; Address; Age; Age-Years; American; Animals; Area; Arsenic; Case-Control Studies; Clinical; Consultations; Consumption; County; Data; Data Collection; Dose; Embryo; Enrollment; Epidemiologic Studies; European Union; Evaluation; Event; Exposure to; Funding; Future; Gestational Age; Government; Guide prevention; Health; Home environment; Hospitals; Human; In Vitro; Incidence; Individual; Informed Consent; Investigation; Laboratories; Laboratory Animal Models; Location; Maternal Exposure; Measures; Medical; Medical center; Meiosis; Molecular Epidemiology; Monitor; Mothers; Mus; National Research Council; Nature; No-Observed-Adverse-Effect Level; Nurses; Oocytes; Participant; Patient Self-Report; Patient currently pregnant; Patients; Persons; Population; Population Study; Populations at Risk; Pregnancy; Pregnancy loss; Pregnant Women; Prenatal care; Public Health; Publishing; Questionnaires; Reporting; Reproduction; Research; Research Design; Resources; Risk; Risk Assessment; Risk Factors; Romania; Sampling; Site; Source; Surveys; Technology; Toxic effect; United States; Water Pollution; Water Supply; Water consumption; Weight; Woman; Workplace; data collection methodology; density; drinking; drinking water; embryo/fetus; epidemiology study; exposed human population; fetal; remediation; reproductive; residence; steroid hormone

DESCRIPTION (provided by applicant): Maternal exposure to concentrations of inorganic arsenic (iAs) in excess of 10 parts per billion (ppb) has been identified as a risk factor for clinically recognized spontaneous pregnancy loss in several epidemiologic studies. The majority of the studies reported to date assessed persons residing in regions well-known for substantial levels of groundwater iAs contamination. A far larger global population, likely to include tens of millions of U.S. residents, are exposed to mild-moderate iAs concentrations via drinking water contamination; those less than 10 ppb iAs. Although limited, human, animal and in vitro studies suggest an increased risk for spontaneous pregnancy loss in association with exposure to mild-moderate drinking water iAs concentrations. To date, only one study, conducted from 1976-1978, targeted a population with drinking water iAs exposures less than 10 ppb, and detected a 50% increased risk for spontaneous loss of a clinically recognized pregnancy. Given the high baseline risk for the spontaneous loss of clinically recognized pregnancies among humans (i.e., 12-24%), and the widespread distribution of exposure to drinking water with mild-moderate iAs contamination even a modest increase in risk would incur a substantial number of attributable events. We propose a preliminary evaluation of associations between drinking water iAs exposure and the spontaneous loss of clinically recognized pregnancies of less than 20 weeks completed gestation, and to assess the feasibility of participant recruitment and data collection strategies at a large urban medical center in western Romania. This area of Romania is well-known for mild-moderate iAs contamination of drinking water sources providing a wide range of exposures below 10 ppb. Moreover, prenatal care is compulsory and government funded in Romania facilitating nearly complete ascertainment of the proposed study population comprised of newly pregnant women 18-44 years of age. We will employ a case-control study design with incidence density sampling of 150 cases and 150 controls matched by gestational age (1:1). Individual historical drinking water exposure data collected by nurse-administered questionnaire, augmented by laboratory iAs measures in reported drinking water sources will be used to assign exposure across critical windows for reproduction. We hypothesize that exposures to greater amounts of iAs through the consumption of drinking water at home and at the workplace, prior to and during gestation, will increase the risk for spontaneous pregnancy loss. Our proposed study will provide preliminary data to permit and evaluation of the best approach for a larger multi- site confirmatory study to address this critical data gap concerning low-moderate drinking water iAs contamination and spontaneous pregnancy loss. These data are vital for the protection of expectant mothers and their embryos and fetuses from a possibly lethal and widespread risk factor for loss. PUBLIC HEALTH RELEVANCE: This study will comprise a preliminary assessment of associations between the consumption of drinking water with low-moderate concentrations of inorganic arsenic (i.e., <10 parts per billion, ppb), naturally present in ground drinking water sources, and the spontaneous loss of clinically recognized pregnancies of less than 20 weeks completed gestation. In the United States and worldwide millions of women of reproductive age are exposed to low-moderate concentrations of arsenic in drinking water and remediation technologies are costly. Although substantial evidence suggests that exposure to levels of inorganic arsenic in drinking water >10 ppb increases the risk for a spontaneous pregnancy loss, very little research has been conducted concerning the low-moderate levels of inorganic arsenic to which a far greater number of people are exposed.

描述（由申请人提供）：在几项流行病学研究中，孕产妇暴露于超过10十亿（PPB）的无机砷（IAS）浓度超过10份（PPB）。迄今为止，大多数研究评估了居住在众所周知的地下水IAS污染的地区。全球人口更大，可能包括数千万美国居民，通过饮用水污染暴露于温和的IAS浓度；那些小于10 ppb的IAS。尽管有限，但人类，动物和体外研究表明，与暴露于温和的饮用水IAS浓度相关的自发怀孕丧失风险增加。迄今为止，只有一项从1976 - 1978年进行的研究针对的是饮用水IAS暴露的人群小于10 ppb，并且发现自发丧失临床认可的怀孕的自发丧失风险增加了50％。鉴于人类自发丧失临床认可的妊娠的高基线风险（即12-24％），并且在饮用水暴露的广泛分布中，饮用水中有轻度的IAS污染，即使风险的适度增加也会引起大量可归因的事件。我们提出对饮用水IAS暴露与临床认可的临床认可的怀孕少于20周之间的自发丧失之间的关联的初步评估，并评估西部罗马尼亚大型城市医疗中心的参与者招募和数据收集策略的可行性。罗马尼亚的这一地区因饮用水源的温和中度IAS污染而闻名，可提供低于10 ppb的广泛暴露。此外，产前护理是强制性的，政府在罗马尼亚资助，几乎完全确定了由18-44岁新孕妇组成的拟议研究人群。我们将采用病例对照研究设计，其发病率密度采样150例和150例与胎龄相匹配的对照（1：1）。由护士管理调查表收集的个人历史饮用水暴露数据，通过报告的饮用水源的实验室IAS措施的增强将用于分配跨关键窗户的曝光以进行繁殖。我们假设通过在家中和工作场所消耗饮用水，在妊娠之前和期间，会增加自发怀孕损失的风险，从而增加了更多的IAS。我们提出的研究将提供初步数据，以允许和评估更大的多站点验证性研究的最佳方法，以解决有关低中度饮用水IAS污染和自发怀孕丧失的关键数据差距。这些数据对于保护预期母亲及其胚胎和胎儿免受可能损失的致命和广泛风险因素至关重要。 公共卫生相关性：这项研究将构成对饮用水的消费量低的无机砷浓度（即，<十亿分之10，PPB）之间的关联，自然存在于地面饮用水中，与自发认可的临床丧失少于20周的临床丧失。在美国和全球数百万的生殖年龄妇女中，饮用水中的砷和补救技术的浓度很高。尽管大量证据表明，饮用水中无机砷的暴露水平> 10 ppb增加了自发妊娠损失的风险，但关于低温中低温砷的研究很少进行，而无机砷的水平很大。