Efectividad de la intervención en tabaquismo para el abandono del consumo de tabaco en mujeres embarazadas en atención primariaensayo clínico aleatorizado y controlado por conglomerados. Proyecto gestabac

Resumo

Objective: To evaluate the effectiveness of a non-pharmacological intervention strategy to help pregnant smokers to give up smoking. Methods: Design: Randomized Clinical Trial, multicenter, pragmatic, with concurrent parallel-groups, prospective and clusterrandomized. Allocation Unit: primary healthcare clinics (PHCC). Analysis Unit: Pregnant woman. Setting: 20 PHCC of the Madrid Health Service (MHS). Participants: Pregnant woman ≤ 20 gestation weeks (GW), ≥ 18 years old, current smokers or recent exsmokers, who were able to comply with the requirements of the study in their first prenatal check-up, wished to participate and signed the Informed Consent Document. Group size: 350 pregnant women signed up for a period of 12 months. Interventions: In the control group, the usual clinical practice was applied to help the pregnant women to give up smoking. In the intervention group, a brief and structured educational intervention that follows the "5As" algorithm to help pregnant women stop smoking and prevent relapse, was applied (Gestabac intervention). Primary outcome: Effectiveness of the structured intervention on continued smoking abstinence during pregnancy (between 28-30 GW and between 38 GW and delivery). Results: We included 350 pregnant smokers or recent ex-smokers with an average age of 31±4.59 years old (Average ±SD). They had spontaneously stopped smoking at the beginning of the study, 21.43% of women. The combined abstinence rate (self-report and CO-oximeter) with cutoff point <7 ppm) between 28-30 GW was 53.1% in the Gestabac arm and 51.2% in the control arm, OR 1.08 (CI 95%: 0.65-1.08), between 38 GW and delivery was 60% in the Gestabac group and 59% in the control group, OR 1.04 (95%: CI 0.58-1.88). There were more attempts to quit during the follow-up in the intervention group throughout the study. Conclusions: Women had spontaneously stopped smoking at 21.43% at the beginning of their pregnancies without any type of intervention. Interaction with the health system, even in the absence of a formal and structured intervention, can significantly increase the proportion of women who quit smoking. A brief and structured non-pharmacological intervention, applied by trained Primary Care professionals increases the attempts to quit and can increase tobacco abstinence.