Supplement-The impact of electronic cigarettes (e-cigs) on perinatal immune responsiveness and birth outcomes in Appalachia

补充-电子烟（e-cigs）对阿巴拉契亚地区围产期免疫反应和出生结果的影响

• 批准号: 9403722
• 负责人: Kristin H. Ashford
• 金额: $ 2.87万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9403722
• 关键词: 1-Butanol; Adult; Adverse effects; Air; Analysis of Covariance; Appalachian Region; Awareness; Behavior; Biological; Biological Markers; Birth; Birth Weight; Bone Density; Butanones; Carbon Monoxide; Cigarette; Cotinine; Data; Data Analyses; Electronic cigarette; Exhibits; Female of child bearing age; Fetal Development; Fetus; Gestational Age; Goals; Harm Reduction; Health; Heart Diseases; Immune; Immune response; Immunologic Markers; Immunologics; Infant; Interleukin-1 beta; Interleukin-10; Interleukin-6; Interleukin-8; Interleukins; Kentucky; Liquid substance; Literature; Malignant neoplasm of lung; Marketing; Measures; Methods; National Institute of Drug Abuse; Nature; Neutrophil Collagenase; Nicotine; Nitrosamines; Outcome; Participant; Perception; Perinatal; Pharmaceutical Preparations; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Premature Birth; Recruitment Activity; Relapse; Research; Risk; Safety; Series; Serum; Serum Immunologic; Smoke; Smoking; Smoking Behavior; Smoking Status; Spontaneous abortion; Surveys; TNF gene; Teratogenic effects; Time; Tobacco; Tobacco use; United States; United States Food and Drug Administration; Urine; Vulnerable Populations; Woman; Work; adverse pregnancy outcome; authority; burden of illness; carcinogenicity; cigarette smoking; cytokine; design; experience; maternal tobacco use; modifiable risk; mortality; nicotine use in pregnancy; novel; premature; prenatal; prenatal smoking; prospective; public health relevance; smoking cessation; urinary; virtual

 DESCRIPTION (provided by applicant): The United States has the largest and fastest growing market for electronic cigarettes (e-cigs), and adult women of childbearing age are the most common users. However, no data exist regarding the health effects of e-cigs on pregnant women or their babies. It is well known that tobacco use during pregnancy is the most modifiable risk associated with adverse birth outcome, yet nearly one in four women in Kentucky continue to use tobacco products during pregnancy. E-cigs also contain varied (unregulated) concentrations of nicotine, despite nicotine being classified as a pregnancy class-D drug (exhibiting teratogenic effects on the fetus). The addictive nature of nicotine may explain continued use during this vulnerable time. E-cigs have been the center of recent controversy regarding novel smoking cessation or harm reduction products. There is also concern that marketing strategies promoting harm reduction may increase the appeal and obfuscate the known adverse effects of nicotine on fetal development. In addition to the adverse effects of prenatal nicotine, maternal tobacco use alters immune response during pregnancy, placing women at increased risk for preterm birth. We plan to build on previous work to determine the impact (better, same, or worse) that e-cigs and dual use (conventional + e-cig) have on prenatal immune response and birth outcomes compared to conventional use and dual use. Our overall goal is to determine the effects of e-cigs (and dual use) on perinatal biomarkers and birth outcomes. Three hundred and sixty pregnant women will be recruited. Participants will complete a survey to measure tobacco related behaviors, and provide perinatal biomarkers at four time points (each trimester and postpartum). Data analysis will include a series of repeated ANCOVAs to determine the association of perinatal cigarette smoking (conventional, e-cigarettes-only, and dual use) with perinatal biomarkers. A one- way ANCOVA will be used to determine the association with birth outcomes. Primary biomarker measures include: expired air carbon monoxide, urine and serum cotinine, serum immune markers and urinary NNAL. Gestational age at birth and birth weight are the primary birth outcomes. Until more data about the effects of e-cigs and dual use on perinatal immune response and birth outcomes are available, promotion of e-cigs during pregnancy would be premature. There is an urgent need to investigate the impact of e-cigs and dual use on perinatal biomarkers and birth outcomes. The lack of research may unnecessarily place women-and their babies -at risk for lifelong adverse health outcomes.

 描述（申请人提供）：美国拥有最大、增长最快的电子烟市场，育龄成年女性是最常见的使用者。然而，没有关于电子烟对孕妇或婴儿健康影响的数据。众所周知，怀孕期间吸烟是与不良出生结果相关的最可改变的风险，但肯塔基州近四分之一的妇女在怀孕期间继续使用烟草产品。电子烟也含有不同浓度的尼古丁，尽管尼古丁被归类为妊娠D类药物（对胎儿有致畸作用）。尼古丁的成瘾性可能解释了在这段脆弱的时间里持续使用的原因。电子烟一直是最近关于新型戒烟或减少危害产品的争议的中心。还有人担心，促进减少危害的营销策略可能会增加吸引力，并混淆尼古丁对胎儿发育的已知不良影响。除了产前尼古丁的不良影响外，母亲吸烟会改变怀孕期间的免疫反应，使妇女面临更大的早产风险。我们计划在以前的工作的基础上，确定与常规使用和双重使用相比，电子烟和双重使用（常规+电子烟）对产前免疫反应和出生结果的影响（更好，相同或更差）。我们的总体目标是确定电子烟（和双重使用）对围产期生物标志物和出生结果的影响。将招募360名孕妇。参与者将完成一项调查，以测量烟草相关行为，并在四个时间点（每个三个月和产后）提供围产期生物标志物。数据分析将包括一系列重复的ANCOVA，以确定围产期吸烟（传统，仅电子烟和双重使用）与围产期生物标志物的关联。将使用单因素ANCOVA确定与出生结局的相关性。主要的生物标志物测量包括：呼气一氧化碳、尿液和血清可替宁、血清免疫标志物和尿NNAL。出生时的胎龄和出生体重是主要的出生结局。在获得更多关于电子烟和双重使用对围产期免疫反应和出生结果的影响的数据之前，在怀孕期间推广电子烟还为时过早。迫切需要调查电子烟和双重使用对围产期生物标志物和出生结果的影响。缺乏研究可能会不必要地将妇女及其婴儿置于终身不良健康后果的风险之中。