N/A
N=49
Smoking Cessation Intervention in Pregnant Women
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03024606 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Exhaled Carbon Monoxide Levels — 8; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- text messages focused on smoking cessation and pregnancy (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- St. Louis University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exhaled Carbon Monoxide Levels |
8; 5 | — |
Summary
The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed pregnancy,
- English speaking,
- 18-55 years of age,
- Are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation,
- Have a cellular phone that is capable of receiving text messages, and be willing to pay for any related fees for testing.
- Willing and able to commit to the visit schedule
Exclusion Criteria
- Gestational age > 35 weeks at quit date
- If subjects are in the pre-contemplative or contemplative stages of change or have already received 30 minute pharmacy education targeted for the quit date in this pregnancy.
Data sourced from ClinicalTrials.gov (NCT03024606). 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.