Clinical trial NCT02553577: Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes
Official title: The Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes in Appalachia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Response
Birth Weight
Gestational Age
Keywords: prenatal
cytokines
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
First posted: 2015-09-17
Enrollment: 278
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
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)

Brief 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Gestational age at birth
timeFrame: Up to nine months
Secondary outcomes:
measure: Infant birth weight
timeFrame: Up to two hours
measure: Change in Prenatal Cytokine level in each trimester and postpartum
timeFrame: 14 weeks; 24 weeks; 34 weeks; 48 weeks and up to 64 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kristin B Ashford, PhD
role: PRINCIPAL_INVESTIGATOR
References: