A randomised controlled trial of a high intensity smoking intervention for pregnant Indigenous women

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12609000929202
• Date of registration: 28/10/2009
• Primary sponsor: Individual Professor Sandra Eades
• Public title: A randomised controlled trial of a high intensity smoking intervention for pregnant Indigenous women
• Scientific title: The effect of a multifaceted high intensity culturally specific intervention incorporating advice, support and nicotine replacement on smoking cessation rates in pregnant Indigneous women: a randomised controlled trial.
• Date of first enrolment: 1/11/2005
• Target sample size: 270
• Recruitment status: Closed: follow-up complete
• URL: http://www.anzctr.org.au/ACTRN12609000929202.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Australia

Contacts

• Name: Professor Sandra Eades

• Name: Sandra Eades

Key inclusion & exclusion criteria

Inclusion criteria: Pregnant and attending for antenatal care before 20 weeks gestation
Exclusion criteria: major mental illness or chemical dependency other than tobacco or alcohol

Age minimum: 16 Years
Age maximum: 50 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Smoking in pregnancy

Intervention(s)

A multifaceted tailored intervention including culturally specific advice and support for Indigenous participants, evidence based communication and nicotine replacement after 2 failed quit attempts. From the time the woman engages in an active quit attempt she is seen again in the clinic at a minimum of 2 visits within 5 and 14 days of the visit at which she agrees to attempt to quit smoking with support and advice. If after two visits with support and advice she is still a smoker trying to quit with no contrainications to nicotine replacement therapy and she is prescribed nicotine gum. For smokers of less than 25 cigarettes per day the 2mg gum is prescribed as required up to 24 times per day and for smokers of more than 25 cigarettes per day the 4 mg gum is prescribed. The gum is prescribed as needed for up to 12 weeks.

Primary Outcome(s)

Self report and continine validated smoking cessation

Secondary Outcome(s)

Mean birth weight and gestational age as recorded on the hospital discharge form.

Source(s) of Monetary Support

National Health and Medical Research Council

Secondary Sponsor(s)

Professor Rob Sanson Fisher