Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes

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.

Inclusion Criteria:

1. current tobacco use (traditional cigarettes and/or electronic cigarettes ecig, ENDS)

2. pregnant in the first or second trimester

3. age 18-44

4. can read and write in English.

Exclusion Criteria: