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

Not Applicable

Completed

• Conditions: Cessation, Smoking

• Registration Number: NCT01872156
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

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.

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Study Start: 2013-12
• Primary Completion: 2014-12
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of abstinence of tobacco	6 months	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.

Trial Locations

Locations (1)

Gerencia de Atención Primaria; 🇪🇸 Madrid, Spain