Helping pregnant women quit smoking in New Aquitaine using the 5A strategy
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.
This study is testing a new approach to help pregnant women in New Aquitaine quit smoking by using a strategy that combines different support methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4505 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05355012 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the 5A-QUIT-N organizational strategy for smoking cessation among pregnant women in New Aquitaine, France. It employs a pragmatic cluster randomized trial design to optimize existing resources and understand barriers to implementing smoking cessation interventions. The focus is on adapting proven strategies to the French healthcare context, leveraging a comprehensive approach that combines multiple interventions. Data will be collected from healthcare professionals, stakeholders, and women who have recently given birth and smoke.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who smoke and have recently given birth in the New Aquitaine region.
Not a fit: Patients who are not pregnant or who do not smoke may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce smoking rates among pregnant women, leading to better health outcomes for mothers and their babies.
How similar studies have performed: Previous studies have shown that comprehensive interventions based on the 5A model can be effective in promoting smoking cessation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux
- CHU de Bordeaux, Hôpital Saint-André — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: François Alla, Prof — University Hospital, Bordeaux
- Study coordinator: François Alla, Prof
- Email: francois.alla@u-bordeaux.fr
- Phone: +335 57 82 26 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.