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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01872156
Other study ID # SOMAMFYC11/2012
Secondary ID
Status Completed
Phase N/A
First received April 24, 2013
Last updated August 11, 2017
Start date December 2013
Est. completion date July 2017

Study information

Verified date August 2017
Source Gerencia de Atención Primaria, Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date July 2017
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Gerencia de Atención Primaria Madrid

Sponsors (1)

Lead Sponsor Collaborator
Gerencia de Atención Primaria, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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