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

Study 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: 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.

Official Title
-----------------
Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.

Conditions
-----------------
Cessation, Smoking

Intervention / Treatment
-----------------
* Other: Intervention GESTABAC
* Other: Control Group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention GESTABAC<br>Intervention based on the Clinician's Guide to helping Pregnant Women Quit Smoking on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth. | Other: Intervention GESTABAC<br>* Intervention based on the Clinician's Guide to helping Pregnant Women Quit Smoking on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth.<br>|
| Other: Control Group<br>The group control will act according to usual management. | Other: Control Group<br>* The group control will act according to usual management.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of abstinence of tobacco | 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. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, Primary care