Cessation, Smoking Clinical Trial
— GESTABACOfficial title:
Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.
Verified date | August 2017 |
Source | Gerencia de Atención Primaria, Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 350 |
Est. completion date | July 2017 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Gerencia de Atención Primaria | Madrid |
Lead Sponsor | Collaborator |
---|---|
Gerencia de Atención Primaria, Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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