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

NCT ID: NCT01872156

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-07-31

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:

1. 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.

2. The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality.

3. 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.

Conditions

Cessation, Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention GESTABAC

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.

Group Type: EXPERIMENTAL

Intervention GESTABAC

Intervention Type: 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.

Control Group

The group control will act according to usual management.

Group Type: OTHER

Control Group

Intervention Type: OTHER

The group control will act according to usual management.

Interventions

Intervention GESTABAC

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 Type: OTHER

Control Group

The group control will act according to usual management.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Encarnación Serrano-Serrano, MD

Role: PRINCIPAL_INVESTIGATOR

Gerencia de Atención Primaria, Madrid

Locations

Gerencia de Atención Primaria

Madrid, , Spain

Countries

Spain

Related Links

http://gestabac.wordpress.com

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

Other Identifiers

SOMAMFYC11/2012

Identifier Type: -

Identifier Source: org_study_id