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

Title: The impact of electronic cigarettes (e-cigs) on perinatal immune responsiveness and birth outcomes in Appalachia Keywords: pregnancy; smoking; electronic cigarettes; biomarkers; preterm birth ABSTRACT The US has the largest and fastest growing market for e-cigs and adult women are the most common users. Today, Kentucky ranks among the highest states (2nd) in prenatal smoking and in smoking-attributable morbidity and mortality (1st). Nearly one in four pregnant women in Kentucky continues to use tobacco products, reflecting the addictive nature of nicotine. Women who smoke are more likely to experience heart disease, lung cancer, reduced bone density, miscarriage and preterm birth. Furthermore, more women try to stop smoking during pregnancy than any other time in their lives. Although pregnant smokers (conventional users) are aware of the need to quit, some use reduction (i.e. cutting down) as a method of quitting and believe in harm reduction. However, despite the best of intentions, it is possible that e-cig use during pregnancy could increase harm as a result of dual use, switching, and relapse. It is also plausible that prenatal e-cig use could lead to cessation. As such, Electronic Nicotine Delivery Systems (ENDS, including e-cigs) have been the center of recent controversy regarding novel ‘smoking cessation’ or ‘harm reduction’ products which putatively can reduce disease burden and possibly mortality. 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, despite nicotine being classified by the Food and Drug Administration (FDA) as a pregnancy class D drug demonstrating teratogenic effects on the developing fetus. To date, no data exist on the impact of e-cigs on the prenatal and postpartum immune response. Moreover, no data exist on the impact of e-cigs on birth outcomes. We plan to build on our previous work demonstrating conventional tobacco use decreases the antiinflammatory response via significant reductions in interleukin 10 (IL-10) and further increasing the risk for PTB. We plan to determine the impact (better, same, or worse) that e-cigs have on perinatal immune response compared to conventional smoking. Given the paucity of information about e-cig use in pregnancy and the postpartum period, and the potential adverse effects on reproductive health and birth outcomes, the specific aims of this study are to 1. determine the association of perinatal e-cigarette use with a) serum nicotine; b) expired carbon monoxide; and c) serum immune markers (IL-2, IL-6, IL-10, CRP, TNF, MMP-8) throughout pregnancy and postpartum; and 2. determine the association of prenatal e-cigarette use with birth outcomes (gestational age at birth, birth weight).