Stop Smoking in its Tracks”: a single arm intervention study of a smoking cessation program for women receiving maternity care through the Birthing in Our Community program. A sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study

Not Applicable

Completed

• Conditions: Smoking cessation; Public Health - Health service research; Reproductive Health and Childbirth - Antenatal care; Reduction in smoking; Mental Health - Addiction

• Registration Number: ACTRN12615001278527
• Lead Sponsor: Prof Sue Kildea

Brief Summary

ot yet

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-24
• Study Completion: 2019-04-08
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

Receiving antenatal care through the BiOC program. Women are eligible for BiOC if they identify as Aboriginal and/or Torres Strait Islander, or are partnered to an Aboriginal and/or Torres Strait Islander person, and/or are having an Aboriginal and/or Torres Strait Islander baby.

Self-reported daily (at least one cigarette per day) smoking during pregnancy, prior to 36 weeks gestation.

Consent to participate.

Exclusion Criteria

Women are not eligible to participate if they are:

Unable/unwilling to provide written consent

Baseline salivary cotinine <10ng/ml.

N.B. Although this study is not specifically targeting young women, we are guided by the National Statement in that women will not be excluded on the basis of youth (age<16) alone. The study will also be guided by usual practice employed for clinical procedures whereby the best interests of the young woman, and her capacity to consent, will be assessed on an individual basis. Hence, young women who are mature enough to understand and consent, and are not vulnerable through immaturity in ways that warrant additional consent from a parent or guardian” (National Statement: 155) will be invited to consent in their own right. Where there is any concern that immaturity renders a young woman vulnerable, she will not be invited to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants who self-report abstinence for the previous seven days, validated by salivary cotinine <10ng/ml, using the NicAlert Registered Trademark (Nymox Pharmaceutical Corporation, USA) system[36 weeks pregnancy and six months postpartum]