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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
- 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.
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.
| Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Sampling Method: | Non-Probability Sample |
- 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
Inclusion Criteria:
- 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.
- Participant is ≤ 24 weeks gestation for conventional smokers and ≤ 36 weeks gestation for e-cig users or dual users.
- at least 16 years of age
- able to speak English or Spanish;
- able to read and sign consent form
- intent to carry pregnancy to term.
Exclusion Criteria:
- current drug or alcohol abuse or dependence (other than methadone or buprenorphine maintenance)
- participant uses combustible marijuana more than 3 times per week (use of edibles/oils is permitted
- unstable psychiatric disorder
- unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- known congenital abnormality
- Regular use of tobacco products other than conventional or e-cigs
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, MA | 860-679-4647 | mgenova@uchc.edu | |
| Contact: Sheila Thurlow, MSN, RN | 860-679-4637 | thurlow@uchc.edu |
| 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 | |
| Principal Investigator: | Erin Mead-Morse, MD, MPH | UConn Health |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Nicotine Nicotine addiction Tobacco Use Disorder Pregnancy Electronic cigarettes Cigarettes |
Vaping Carcinoma Pregnant Birth Outcomes E-liquid |
|
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |