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RECRUITING

NCT05355012

Organization of Smoking Cessation in Pregnant Women With the Implementation of the 5A Strategy in New Aquitaine.

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

The investigators are conducting a pragmatic cluster randomized trial in stepped-wedge of which objectives are to evaluate the effectiveness and the conditions of effectiveness of an organizational strategy for smoking cessation - 5A-QUIT-N - among pregnant women in New Aquitaine (NA), by using and optimizing existing resources

Official title: Organization of Smoking Cessation in Pregnant Women: Study of the Effectiveness, Transferability, Barriers and Facilitators of the Implementation of the 5A Strategy in French Context. A Cluster Randomized Controlled Trial in New Aquitaine.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4505

Start Date

2022-10-03

Completion Date

2026-05-31

Last Updated

2023-10-25

Healthy Volunteers

Conditions

Smoking Cessation Pregnancy Related

Interventions

OTHER

5A organizational innovation

This project is based on three strategic axes: * A gradation of the care offer allowing to adapt the means and resources mobilized on the territory * Personalized care by developing specific treatment paths based on the risk factors and/or vulnerabilities of the pregnant woman * Coordination of territorial resources to support pregnant women in quitting smoking These three key elements will make it possible to propose a partnership-based, multi-professional, coordinated and integrated approach to the territory, supported by the technical resources and expertise available in the territory. It invites a majority of non-specialized actors to invest in the process of supporting pregnant women in quitting smoking, multiplying and potentiating their actions with this population.

In this research, there are 4 categories of research participants: * Healthcare professionals: the target of the 5A-QUIT-N intervention from whom data will be collected to meet the secondary objective of the effectiveness conditions. * Stakeholders: individuals involved in the implementation of the research and intervention from whom data will be collected to meet the secondary objective of the effectiveness conditions. * Women who have just given birth and who smoke tobacco in early pregnancy: indirect beneficiaries of the intervention, from whom data will be collected to meet the primary objective of effectiveness. * Co-parent (partner) of the new-born child of the woman who has just given birth included in the study Inclusion criteria for the intervention The inclusion criteria for the clusters are : \- Territory of maternity attractiveness in New Aquitaine The inclusion criteria for care providers within the clusters are: * All institutions, structures and organizations and health professionals likely to participate in the follow-up of pregnant women * All institutions, structures and organizations and health professionals specializing in addictology or tobaccoology The inclusion criteria for pregnant women within the clusters are : \- All pregnant women who have smoked tobacco (at least 2 times a week, for at least 1 week) during the pregnancy (including the period when she was unaware of the pregnancy) Inclusion criteria for the primary objective measures: The inclusion criteria for women are (for data collection): * Have given birth in a New Aquitaine maternity hospital, * Reside in New Aquitaine * To have been followed for the pregnancy in the territory of the maternity of delivery * To have used tobacco during (at least 2 times a week, for at least 1 week) the pregnancy (including the period when she was unaware of the pregnancy) * Be over 18 * Have given free, informed and express consent * Exclusion criteria: Non-inclusion criteria for the intervention Cluster non-inclusion criteria: * Pilot territory (territory of attractiveness of the Arcachon maternity hospital) * Impossibility of collecting the main judgment criterion in the cluster Within these clusters, the health care providers and the pregnant women are all concerned and therefore do not have any non-inclusion criteria. Non-inclusion criteria of measures for the primary objective: The criteria for non-inclusion of women who have just given birth are: * Not speaking French, * Have COVID during delivery * Use only electronic cigarettes, * Under legal protection (guardianship, curatorship, safeguard of justice) * Women giving birth under X * Women giving birth to a stillborn baby * Women having made a denial of pregnancy * Women who have their child in neonatal intensive care * Women who have been fully monitored for their pregnancy outside of New Aquitaine

Locations (1)

CHU de Bordeaux, Hôpital Saint-André

Bordeaux, France