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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Gerencia de Atención Primaria, Madrid
Sponsor:
Information provided by (Responsible Party):
Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01872156
First received: April 24, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Cessation, Smoking
Other: Intervention GESTABAC
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Rate of abstinence of tobacco [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
Control Group
The group control will act according to usual management.
Other: Control Group
The group control will act according to usual management.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872156

Contacts
Contact: Encarnación Serrano-Serrano, MD 653672669 messerrano@telefonica.net
Contact: César Minué-Lorenzo, MD 679677980 cminue@hotmail.com

Locations
Spain
Gerencia de Atención Primaria Not yet recruiting
Madrid, Spain, 28850
Contact: Encarnación Serrano-Serrano, MD    653672669    messerrano@telefonica.net   
Contact: César Minué-Lorenzo, MD    679677980    cminue@hotmail.com   
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Investigators
Principal Investigator: Encarnación Serrano-Serrano, MD Gerencia de Atención Primaria, Madrid
  More Information

Additional Information:
No publications provided

Responsible Party: Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01872156     History of Changes
Other Study ID Numbers: SOMAMFYC11/2012
Study First Received: April 24, 2013
Last Updated: June 6, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Gerencia de Atención Primaria, Madrid:
Smoking
Primary care

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 24, 2014