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Electronic Cigarette Use During Pregnancy

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ClinicalTrials.gov Identifier: NCT03480373
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : September 30, 2019
Sponsor:
Collaborators:
University of Colorado, Denver
Hartford Hospital
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Cheryl Oncken, UConn Health

Tracking Information
First Submitted Date March 21, 2018
First Posted Date March 29, 2018
Last Update Posted Date September 30, 2019
Actual Study Start Date June 18, 2018
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
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.
Original Primary Outcome Measures
 (submitted: March 21, 2018)
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. [ Time Frame: 9 months ]
A1.Multivariate analysis of variance (MANOVA) with repeated measures will be used to evaluate metabolite of tobacco-specific carcinogenic nitrosamine nicotine-derived nitrosamine ketone (NNAL) and cotinine as a multivariate DV by trimester by Cigarette Status (Cigarette v Dual Users v E-Cig) at each time point (trimester). The following variables will be entered as static covariates: recruitment site, age, gestational age at intake, cigarettes per day prior to pregnancy.
Change History Complete list of historical versions of study NCT03480373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electronic Cigarette Use During Pregnancy
Official Title Electronic Cigarette Use During Pregnancy
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Cigarette Smoking-Related Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 21, 2018)
375
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
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. ≤ 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Marla Genova, MA 860-679-4647 mgenova@uchc.edu
Contact: Sheila Thurlow, MSN, RN 860-679-4637 thurlow@uchc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03480373
Other Study ID Numbers 17-180-6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Cheryl Oncken, UConn Health
Study Sponsor UConn Health
Collaborators
  • University of Colorado, Denver
  • Hartford Hospital
  • Roswell Park Cancer Institute
Investigators
Principal Investigator: Cheryl Oncken, MD, MPH UConn Health
PRS Account UConn Health
Verification Date September 2019