Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Rate of abstinence of tobacco
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of abstinence of tobacco
时间窗: 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.
次要结局
未报告次要终点