Immune Response Clinical Trial
Official title:
The Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes in Appalachia
Verified date | July 2021 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Kristin Ashford | Virginia Commonwealth University |
United States,
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 |
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