Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women
This trial is active, not recruiting.
|Treatments||intervention gestabac, control group|
|Sponsor||Gerencia de Atención Primaria, Madrid|
|Start date||December 2013|
|End date||December 2014|
|Trial size||600 participants|
|Trial identifier||NCT01872156, SOMAMFYC11/2012|
The purpose of this study is to evaluate the effectiveness of the behavior treatment accompanied by self-help materials in Primary health care, across the intervention of the midwifes in the pregnancy follow-up visits.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Rate of abstinence of tobacco
time frame: 6 months
Female participants at least 18 years old.
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
|Official title||Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.|
|Principal investigator||Encarnación Serrano-Serrano, MD|
|Description||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: 1. 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. 2. The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality. 3. 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.|
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