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

NCT01872156 | Completed DMC

• 1 other identifier: SOMAMFYC11/2012
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Cessation, Smoking

Keywords

Smoking; Primary care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: Intervention GESTABAC

Control Group

OTHER

The group control will act according to usual management.

Other: Control Group

Interventions

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.

Intervention GESTABAC

Control Group OTHER

The group control will act according to usual management.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• willing and able to give informed consent for participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (1)

Gerencia de Atención Primaria

Madrid, 28850, Spain

Location

Related Links

• An online platform to facilitate communication and dissemination of information between the research group

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Encarnación Serrano-Serrano, MD

  Gerencia de Atención Primaria, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: June 7, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

ES (1)