Electronic Cigarette Use During Pregnancy



Status:Recruiting
Healthy:No
Age Range:16 - 45
Updated:8/17/2018
Start Date:June 18, 2018
End Date:May 31, 2023
Contact:Marla Genova, MA
Email:mgenova@uchc.edu
Phone:860-679-4647

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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.

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.

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. ≤ 13 weeks gestation, however if we identify an electronic cigarette user after 13
weeks gestation we will still enroll her in study. We will enroll an additional
conventional cigarette of a similar gestational age as a control participant.

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. twins or other multiple gestation

3. unstable psychiatric disorder

4. unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis
gravidarum)

5. known congenital abnormality.

6. Current use or intention to use a pharmaceutical aid to quit smoking

7. Regular use of tobacco products other than conventional or e-cigs
We found this trial at
3
sites
Farmington, Connecticut 06032
Principal Investigator: Cheryl Oncken, MD, MPH
Phone: 860-679-4647
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Denver, Colorado 80210
Phone: 303-724-5733
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Hartford, Connecticut 06106
Phone: 860-972-2399
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Hartford, CT
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