NCT03480373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5 years

First QC Date

March 21, 2018

Last Update Submit

September 19, 2023

Conditions

Cigarette Smoking-Related Carcinoma

Keywords

NicotineNicotine addictionTobacco Use DisorderPregnancyElectronic cigarettesCigarettesVapingCarcinomaPregnantBirth OutcomesE-liquid

Outcome Measures

Primary Outcomes (1)

  • To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes.

    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.

    9 months

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado

Denver, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

UCONN Health

Farmington, Connecticut, 06032, United States

Location

Women's Ambulatory Health Services at Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, serum

MeSH Terms

Conditions

Tobacco Use DisorderVapingCarcinoma

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehaviorNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Erin Mead-Morse, MD, MPH

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 29, 2018

Study Start

June 18, 2018

Primary Completion

May 31, 2023

Study Completion

August 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

US(6)