NCT01872156

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cessation, Smoking

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2017-07-01
• First posted: 2013-06-07
• Last updated: 2017-08-14

Locations

1 site across 1 country: Spain