Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women

Aim: To evaluate the efficiency of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on tobacco abstinence at the conclusion of the pregnancy self referred and validated with cooximetry.

Secondary objectives:

• To evaluate the effectiveness of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on the tobacco abstinence 6 months after the childbirth.
• The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality.
• To study the effectiveness of the intervention in smoking on the maintenance of the breast-feeding to 3 and 6 months.

Method:

Design: cluster randomized controlled trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service.

Sample size adjusted for design effect: number of smoking women in every branch would be of 350.

Inclusion criteria

• 18 years of age or older
• pregnant at 20 weeks or less of gestation
• attending her first prenatal visit with any of the participating prenatal care teams (this first prenatal visit takes place usually around 6-12 weeks of pregnancy)
• defining herself as a current cigarette smoker or recent ex-smoker (see below for a definition of these terms)
• being able to meet the requisites of the trial:
• being available for the next 15 months
• defining herself as fluent in reading and speaking Spanish to understand the study procedures and to comply with them

• meeting no exclusion criterion; and
• willing and able to give informed consent for participation in the study

Exclusion criteria

• communication barrier;
• active addictions to other psychoactive substances
• involved in any other formal smoking cessation program or in another trial during the study period; or
• does not consent to participate in the study