Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

Breastfeeding Clinical Trial

Official title:

Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04670822
• Other study ID #: MODCR00004712
• Secondary ID: R21HD091515
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test. Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Recurrence
• Smoking, Cigarette

Intervention

Behavioral:
• Breastfeeding promotion
The intervention group will receive multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants).
• Attention placebo control
The attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support.

Locations

Country	Name	City	State
United States	Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of smoking relapse	The date of postpartum relapse will be defined as the first day after delivery on which an ex-smoker has smoked for 7 consecutive days. Reported smoking abstinence will be verified by urine cotinine test.	6 months postpartum (post-test)
Primary	Rates of smoking relapse	The date of postpartum relapse will be defined as the first day after delivery on which an ex-smoker has smoked for 7 consecutive days. Reported smoking abstinence will be verified by urine cotinine test.	9 months postpartum (follow-up)
Secondary	Breastfeeding duration	Postpartum mothers will report their current feeding method, frequency, and duration of breastfeeding and/or formula use. Breastfeeding status will be visually verified by a female research staff, looking for one of the following indicators of successful breastfeeding in the infant - audible swallowing, a regular suck/swallow/breath pattern, or visible milk in the infant's mouth after they are not latched anymore.	Up to 9 months postpartum