Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes

Immune Response Clinical Trial

Official title:

The Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes in Appalachia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553577
• Other study ID #: 1R01DA040694-01
• Status: Completed
• Start date: January 13, 2016
• Est. completion date: February 28, 2021

Study information

• Verified date: July 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Birth Weight
• Gestational Age
• Immune Response

Locations

Country	Name	City	State
United States	University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Kristin Ashford	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at birth	Investigators will determine if there is a significant difference in gestational age at birth among three groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users	Up to nine months
Secondary	Infant birth weight	Investigators will determine if there is a significant difference in birth weight among three groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users	Up to two hours
Secondary	Change in Prenatal Cytokine level in each trimester and postpartum	Investigators will determine if there are significant changes in cytokine level between trimesters based on groups hree groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users	14 weeks; 24 weeks; 34 weeks; 48 weeks and up to 64 weeks