Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes
Condition: Immune Response; Birth Weight; Gestational Age
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      There has been a dramatic escalation of electronic cigarette (e-cig) use among women of
      childbearing age, including pregnant women. The overall goal of this study is to determine
      the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more
      data about these effects be available to better inform women of childbearing age.
    

Detailed description: 
      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.

      The overall goal of this study 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.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant and postpartum women, age 18-44 who use tobacco products (traditional cigarettes,
        ENDS, electronic cigarettes)
      
Biospecimen description: 
      Serum cytokines: interleukin (IL) IL-1α, IL1β, IL-6, IL-8, IL-10, CRP, TNFα and MMP-8 Urinary
      Cotinine Urinary ( NNAL) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and its
      metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol Expired Carbon Monoxide
    
Keywords: prenatal; cytokines