Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cessation, Smoking
- Sponsor
- Gerencia de Atención Primaria, Madrid
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Rate of abstinence of tobacco
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of abstinence of tobacco
Time Frame: 6 months
Rate of abstinence of tobacco to 20-28 weeks of childbearing , to 36-38 weeks and to 6 postpartum (post-childbearing) months. The abstinence will be validated for cooximetry.