- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02553577
Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes
The Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes in Appalachia
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40356
- University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- current tobacco use (traditional cigarettes and/or electronic cigarettes ecig, ENDS)
- pregnant in the first or second trimester
- age 18-44
- can read and write in English.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Conventional cigarettes -only
Women who are pregnant and use conventional tobacco products -only
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Electronic Cigarette (ecig) (ENDS) -ONLY
Women who are pregnant and use electronic cigarettes (ecigs) -only
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Conventional + ecig use (DUAL)
Women who are pregnant and use conventional + ecigs (dual)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational age at birth
Time Frame: Up to nine months
|
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
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Up to nine months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant birth weight
Time Frame: Up to two hours
|
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
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Up to two hours
|
Change in Prenatal Cytokine level in each trimester and postpartum
Time Frame: 14 weeks; 24 weeks; 34 weeks; 48 weeks and up to 64 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristin B Ashford, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA040694-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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