Clinical trial NCT01872156: Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women
Official title: Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cessation, Smoking
Keywords: Smoking
Primary care
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2013-06-07
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of abstinence of tobacco
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria
Study officials:
affiliation: Gerencia de Atención Primaria, Madrid
name: Encarnación Serrano-Serrano, MD
role: PRINCIPAL_INVESTIGATOR
References: