Phase 4
Completed N=137
Nicotine Replacement for Smoking Cessation During Pregnancy
Source: ClinicalTrials.gov NCT01656733 ↗Enrolled (actual)
137
Serious AEs
49.6%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days — 12; 7 Participants
◆ Published Evidence
Established
21citations · ~3 / year
Randomized Trial of Nicotine Inhaler for Pregnant Smokers.
Summary
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).
Linked Publications
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Randomized Trial of Nicotine Inhaler for Pregnant Smokers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days |
12; 7 | — |
| SECONDARY Exhaled Carbon Monoxide |
5.50; 6.7 | — |
| SECONDARY Birth Weight |
3036.78; 3141.12 | — |
| SECONDARY Gestational Age |
38.61; 39.11 | — |
Eligibility Criteria
Inclusion Criteria
- smoking at least 5 cigarettes per day for the preceding 7 days
- previous attempt to quit smoking during pregnancy by self report
- 13-26 weeks gestation
- at least 16 years of age
- able to speak English or Spanish
- intent to carry pregnancy to term
- stable residence
Exclusion Criteria
- current drug or alcohol abuse or dependence (other than methadone maintenance)
- twins or other multiple gestation
- unstable psychiatric disorder
- unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- known congenital abnormality
Data sourced from ClinicalTrials.gov (NCT01656733) and the linked publication. 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.