Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes

NCT02553577 | Completed DMC

• 1 other identifier: 1R01DA040694-01
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response; Birth Weight; Gestational Age

Keywords

prenatal; cytokines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Infant birth weight

  Up to two hours

• Change in Prenatal Cytokine level in each trimester and postpartum

  14 weeks; 24 weeks; 34 weeks; 48 weeks and up to 64 weeks

Study Arms (3)

Conventional cigarettes -only

Women who are pregnant and use conventional tobacco products -only

Electronic Cigarette (ecig) (ENDS) -ONLY

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

Conventional + ecig use (DUAL)

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

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant and postpartum women, age 18-44 who use tobacco products (traditional cigarettes, ENDS, electronic cigarettes)

You may qualify if:

• 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.

Sponsors & Collaborators

• Kristin Ashford: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton

Lexington, Kentucky, 40356, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum cytokines: interleukin (IL) IL-1α, IL1β, IL-6, IL-8, IL-10, CRP, TNFα and MMP-8 Urinary Cotinine Urinary ( NNAL) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and its metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol Expired Carbon Monoxide

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin B Ashford, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 17, 2015
• Study Start: January 13, 2016
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)