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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention GESTABAC | Experimental | 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. |
|
| Control Group | Other | The group control will act according to usual management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention GESTABAC | Other | 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. |
| 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 |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Encarnación Serrano-Serrano, MD | Gerencia de Atención Primaria, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia de Atención Primaria | Madrid | 28850 | Spain |
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| Label | URL |
|---|---|
| An online platform to facilitate communication and dissemination of information between the research group | View source |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group | Other | The group control will act according to usual management. |
|
| D008722 | Methods |