Electronic Cigarette Use During Pregnancy
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|ClinicalTrials.gov Identifier: NCT03480373|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : August 15, 2018
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.
|Condition or disease|
|Cigarette Smoking-Related Carcinoma|
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|
|Estimated Enrollment :||375 participants|
|Official Title:||Electronic Cigarette Use During Pregnancy|
|Actual Study Start Date :||June 18, 2018|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||May 31, 2023|
- To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes. [ Time Frame: 9 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480373
|Contact: Marla Genova, MAfirstname.lastname@example.org|
|Contact: Sheila Thurlow, MSN, RNemail@example.com|
|United States, Colorado|
|University of Colorado||Recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Jillian Jaskunas, MPH 303-724-5733 firstname.lastname@example.org|
|Sub-Investigator: Beth Bailey, Ph.D|
|United States, Connecticut|
|Farmington, Connecticut, United States, 06032|
|Contact: Marla Genova, M.A. 860-679-4647 email@example.com|
|Contact: Sheila Thurlow, MSN, RN 860-679-4637 firstname.lastname@example.org|
|Principal Investigator: Cheryl Oncken, MD, MPH|
|Women's Ambulatory Health Services at Hartford Hospital||Recruiting|
|Hartford, Connecticut, United States, 06106|
|Contact: Jacqueline DeJesus, MA 860-972-2399 Jacqueline.DeJesus@hhchealth.org|
|Sub-Investigator: Ellen Dornelas, Ph.D|
|Principal Investigator:||Cheryl Oncken, MD, MPH||UConn Health|