Clinical trial NCT03480373: Electronic Cigarette Use During Pregnancy
Official title: Electronic Cigarette Use During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoking-Related Carcinoma
Keywords: Nicotine
Nicotine addiction
Tobacco Use Disorder
Pregnancy
Electronic cigarettes
Cigarettes
Vaping
Carcinoma
Pregnant
Birth Outcomes
E-liquid
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Hartford Hospital
name: Roswell Park Cancer Institute
name: Denver Health Medical Center
name: Baystate Medical Center
name: East Tennessee State University
name: National Cancer Institute (NCI)
First posted: 2018-03-29
Enrollment: 182
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Farmington
country: United States
facility: UCONN Health
state: Connecticut
city: Hartford
country: United States
facility: Women's Ambulatory Health Services at Hartford Hospital
state: Connecticut
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: UConn Health
name: Erin Mead-Morse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: