NCT05355012

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,505

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Oct 2022May 2026

First Submitted

Initial submission to the registry

March 2, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

March 2, 2022

Last Update Submit

October 24, 2023

Conditions

Smoking CessationPregnancy Related

Keywords

Smoking cessationPregnancy5AsHealthcare optimizationTransferabilityHealthcare sustainabilityOrganizational innovation

Outcome Measures

Primary Outcomes (1)

  • Tobacco abstinence at delivery

    The point prevalence of abstinence at delivery, which is the proportion of women reporting abstinence from smoking for at least 7 days at delivery. This criterion is well documented in the literature assessing tobacco use. It has the advantage of detecting the delayed effects of an intervention and can be easily extrapolated.

    At delivery (smoking status of the previous 7 days)

Secondary Outcomes (15)

  • Average number of cigarettes smoked at inclusion

    At inclusion

  • Average number of cigarettes smoked at postpartum

    6 months and 1 year after delivery

  • Attempts to reduce tobacco consumption

    1 to 3 days after delivery

  • Attempts to quit smoking

    1 to 3 days after delivery

  • Continuous abstinence

    1 to 3 days after delivery

  • +10 more secondary outcomes

Study Arms (2)

5A-QUIT-N intervention

EXPERIMENTAL

The 5A-QUIT-N intervention can be defined as multilevel, i.e., it is based on a territorial organization with expected results at the level of professional practice (structuring of practices around the 5A method) and therefore of the care of pregnant women who smoke tobacco. This project is based on three strategic axes: * A gradation of the care offer * Personalized care by developing specific treatment paths * Coordination of territorial resources to support pregnant women in quitting smoking. These 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.

Other: 5A organizational innovation

5A-QUIT-N control

NO INTERVENTION

Usual care in the care of pregnant women who smoke tobacco.

Interventions

5A organizational innovationOTHER

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.

5A-QUIT-N intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Territory of maternity attractiveness in New Aquitaine
  • 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
  • \- 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)
  • 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

You may not qualify if:

  • Pilot territory (territory of attractiveness of the Arcachon maternity hospital)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux, Hôpital Saint-André

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • François Alla, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Alla, Prof

CONTACT

+335 57 82 26 50francois.alla@u-bordeaux.fr

Charlotte Kervran

CONTACT

charlotte.kervran@u-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: In order to evaluate the effectiveness of 5A-QUIT-N, we will conduct a trial in New Aquitaine using a mixed quantitative and qualitative method. The quantitative study is a stepped-wedge cluster randomized trial (SWCRT) with a transition phase (deployment). The duration of each period is set at 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

May 2, 2022

Study Start

October 3, 2022

Primary Completion

May 31, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)