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

 描述(申请人提供)：美国拥有最大和增长最快的电子烟(e-cigs)市场，育龄成年女性是最常见的使用者。然而，目前还没有关于电子烟对孕妇或其婴儿健康影响的数据。众所周知，怀孕期间使用烟草是与不良生育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(不受管制)，尽管尼古丁被归类为怀孕D类药物(对胎儿表现出致畸作用)。尼古丁的成瘾性质可能解释了在这个脆弱的时期继续使用尼古丁的原因。电子烟一直是最近关于新型戒烟或减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，混淆尼古丁对胎儿发育的已知不利影响。除了产前尼古丁的不利影响外，母亲吸烟还会改变怀孕期间的免疫反应，使妇女面临更高的早产风险。我们计划在以前工作的基础上，确定电子烟和双重用途(传统+电子烟)与常规使用和双重使用相比，对产前免疫反应和出生结局的影响(更好、相同或更差)。我们的总体目标是确定电子烟(和双重用途)对围产期生物标记物和出生结局的影响。将招募360名孕妇。参与者将完成一项调查，以衡量与烟草相关的行为，并在四个时间点(每三个月和产后)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(传统吸烟、仅使用电子烟和双重吸烟)与围产期生物标志物的关联。将使用单因素方差分析来确定与出生结果的关联。主要的生物标志物指标包括：呼出的空气一氧化碳、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果。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局影响的数据之前，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用途对围产期生物标记物和出生结局的影响。缺乏研究可能会不必要地将妇女及其婴儿置于终身不利健康后果的风险之中。

 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.