Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electronic Cigarette Use During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480373
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
University of Colorado, Denver
Hartford Hospital
Roswell Park Cancer Institute
Denver Health Medical Center
Baystate Medical Center
East Tennessee State University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Erin Mead-Morse, UConn Health

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.


Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
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
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Marla Genova, MA 860-679-4647 mgenova@uchc.edu
Contact: Sheila Thurlow, MSN, RN 860-679-4637 thurlow@uchc.edu

Locations
Layout table for location information
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Chloe Banel, BS    303-724-2028    chloe.banel@cuanschutz.edu   
Sub-Investigator: Kent S Hjerpe, MD, FACOG         
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Chloe Banel, BS    303-724-2028    chloe.banel@cuanschutz.edu   
Sub-Investigator: Nicki Nguyen, MD         
United States, Connecticut
UCONN Health Recruiting
Farmington, Connecticut, United States, 06032
Contact: Marla Genova, M.A.    860-679-4647    mgenova@uchc.edu   
Contact: Sheila Thurlow, MSN, RN    860-679-4637    thurlow@uchc.edu   
Principal Investigator: Erin Mead-Morse, PhD         
Women's Ambulatory Health Services at Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Jessica Mullins, MD    860-972-1335    jessica.mullins@hhchealth.org   
Sub-Investigator: Ellen Dornelas, Ph.D         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Tiki Govantes    413-333-8508    Tiki.Govantes@Baystatehealth.org   
United States, Tennessee
East Tennessee State University Recruiting
Johnson City, Tennessee, United States, 37614
Contact: Kelly Sheets, MA    276-469-5134    SHEETSKE@mail.etsu.edu   
Sub-Investigator: Beth Bailey, PhD         
Sponsors and Collaborators
UConn Health
University of Colorado, Denver
Hartford Hospital
Roswell Park Cancer Institute
Denver Health Medical Center
Baystate Medical Center
East Tennessee State University
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Erin Mead-Morse, MD, MPH UConn Health
Layout table for additonal information
Responsible Party: Erin Mead-Morse, Assistant Professor, UConn Health
ClinicalTrials.gov Identifier: NCT03480373    
Other Study ID Numbers: 17-180-6
5R01CA207491-04 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erin Mead-Morse, UConn Health:
Nicotine
Nicotine addiction
Tobacco Use Disorder
Pregnancy
Electronic cigarettes
Cigarettes
Vaping
Carcinoma
Pregnant
Birth Outcomes
E-liquid
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms