N/A
N=60
Postpartum Smoking Relapse Prevention by Breastfeeding Promotion
Smoking, Cigarette · Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT04670822 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants Reporting to Breastfeed — 13; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breastfeeding promotion (Behavioral); Attention placebo control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting to Breastfeed |
13; 5 | — |
Summary
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.
Eligibility Criteria
Inclusion Criteria
- Be pregnant or in the first 1 month postpartum
- Be 18 years or older
- Have quit smoking cigarettes during or before this pregnancy
- Be willing to receive infant care and breastfeeding education
- Be able to read, listen, and talk in English
Exclusion Criteria
- Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal
- Current heavy drinking (more than 2 drinks a day)
- Current use of illicit substances
- Being strongly against breastfeeding
Data sourced from ClinicalTrials.gov (NCT04670822). 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.