Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes

NCT ID: NCT02553577

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2021-02-28

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.

Conditions

Immune Response; Birth Weight; Gestational Age

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional cigarettes -only

Women who are pregnant and use conventional tobacco products -only

No interventions assigned to this group

Electronic Cigarette (ecig) (ENDS) -ONLY

Women who are pregnant and use electronic cigarettes (ecigs) -only

No interventions assigned to this group

Conventional + ecig use (DUAL)

Women who are pregnant and use conventional + ecigs (dual)

No interventions assigned to this group

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Kristin Ashford

OTHER

Sponsor Role: lead

Responsible Party

Kristin Ashford

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kristin B Ashford, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

1R01DA040694-01

Identifier Type: NIH

Identifier Source: org_study_id

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