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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01872156

Acronym

GESTABAC

Enrollment

350

Registered

2013-06-07

Start date

2013-12-31

Completion date

2017-07-31

Last updated

2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cessation, Smoking

Keywords

Smoking, Primary care

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.

Interventions

OTHERIntervention 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.

OTHERControl Group

The group control will act according to usual management.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026