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

Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Cessation, Smoking
• Intervention / Treatment: Other: Intervention GESTABAC; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28850
    • Gerencia de atención primaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: Control Group; The group control will act according to usual management.	Other: Control Group; The group control will act according to usual management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Investigators: Principal Investigator: Encarnación Serrano-Serrano, MD, Gerencia de Atención Primaria, Madrid

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Primary care; Smoking
• Other Study ID Numbers: SOMAMFYC11/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED