Electronic Cigarette Use During Pregnancy

Aim 1: To compare the overall toxicant exposure in pregnant women who use electronic cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who smoke conventional cigarettes.

Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes.

Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking-Related Carcinoma

Detailed Description

In addition to examining characteristics of pregnant e-cig users as well as patterns of their product use, this study is innovative in several ways. First, it is the first known study to examine toxicant exposure to cigarettes and e-cigs in a sample of pregnant smokers who are using these products. Although studies have reported on toxic exposures with e-cigs, this is the first study to apply toxic exposure tests to pregnant women.

Second this is the first study to examine the impact of electronic cigarette use on birth outcomes in pregnant smokers. Although e-cigarettes are similar to tobacco cigarettes in that they deliver nicotine, they are distinguished from tobacco cigarettes in that they do not contain many toxic substances such as carbon monoxide and volatile organic compounds. Consequently, similar to nicotine replacement therapies they have the potential to improve birth outcomes. However, it possible that there may be unanticipated negative effects on birth outcomes, and this study could provide a signal for potential other adverse effects (i.e., miscarriages etc.). Third, this study is the first to examine whether e-cigs alter carcinogen exposure to the fetus, which has been implicated in causing low birth weight and in long-term cancer risk for infants born to smokers. Finally, this is the first study to explore formaldehyde in urine as a measurement of conventional smoking and electronic cigarette use.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
    • Denver, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • UConn Health
    • Hartford, Connecticut, United States, 06106
      • Women's Ambulatory Health Services at Hartford Hospital
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Tennessee
    • Johnson City, Tennessee, United States, 37614
      • East Tennessee State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

• Age: at least 16 years of age
• Ethnicity: Hispanic and non-Hispanic. All race and ethnic groups will be eligible
• Gender: Female
• Other characteristics - (e.g. primary language etc.): English or Spanish speaking

Description

Inclusion Criteria:

1. cigarette smokers who exclusively smoke conventional cigarettes daily, or who use e-cigs daily, or who use either product daily and the other product at least weekly.
2. Participant is ≤ 24 weeks gestation for conventional smokers and ≤ 36 weeks gestation for e-cig users or dual users.
3. at least 16 years of age
4. able to speak English or Spanish;
5. able to read and sign consent form
6. intent to carry pregnancy to term.

Exclusion Criteria:

1. current drug or alcohol abuse or dependence (other than methadone or buprenorphine maintenance)
2. participant uses combustible marijuana more than 3 times per week (use of edibles/oils is permitted
3. unstable psychiatric disorder
4. unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
5. known congenital abnormality
6. Regular use of tobacco products other than conventional or e-cigs

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes.	The overall toxicant exposure will be measured at each trimester and adjusted for potential confounding covariates. A multivariate analysis of variance (MANOVA) with repeated measures will be used to evaluate the pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes at each trimester.	9 months

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Cancer Institute (NCI); University of Colorado, Denver; Roswell Park Cancer Institute; Hartford Hospital; Baystate Medical Center; East Tennessee State University; Denver Health Medical Center
• Investigators: Principal Investigator: Erin Mead-Morse, MD, MPH, UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Carcinoma; Pregnancy; Cigarettes; Electronic cigarettes; Nicotine; Nicotine addiction; Vaping; Tobacco Use Disorder; Pregnant; Birth Outcomes; E-liquid
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 17-180-6; 5R01CA207491-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No