N/A
Completed N=74
Smoking Reduction In Gravid Substance Use Disorders
Tobacco Smoking in Mother Complicating Pregnancy · Tobacco Use · Tobacco Smoking
Source: ClinicalTrials.gov NCT04132232 ↗
Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level — 22; 16 participants — p=0.06
Summary
The aim of this study is to encourage smoking cessation in women with substance use disorders by providing knowledge of expired carbon monoxide. We hypothesize that women who are provided knowledge of their expired carbon monoxide and the associated percent fetal carboxyhemoglobin will have a greater success at quitting smoking during pregnancy than women who are not provided this information.
A secondary aim of the study is to correlate expired carbon monoxide throughout pregnancy with infant birth weight.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level |
22; 16 | 0.06 |
Eligibility Criteria
Inclusion Criteria
i. Age 16-45
ii. Singleton gestation
iii. Gestational age at enrollment <24 weeks
iv. Substance use disorder defined as modified National Institute on Drug Abuse ASSIST ≥4
v. Cigarette smoker using ≥10 cigarettes/day interested in quitting
Exclusion criteria
i. Known or suspected fetal growth restriction at enrollment
ii. Known fetal anomaly, aneuploidy, or demise
iii. Not interested in smoking cessation or reduction during pregnancy
iv. E-cigarette use
Data sourced from ClinicalTrials.gov (NCT04132232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.