Assessement of a Test a Financial-incentive Program for Pregnant Women and Their Smoking Partners to Reduce Smoking During Pregnancy. (PREVENT)

Randomized, Multicenter, Regional Study in 3 Parallel Arms to Evaluate the Effectiveness of a Prevention Program Based on a Financial Incentive Aimed at the Pregnant Woman and Her Smoking Partner, Designed to Reduce Tobacco Consumption During Pregnancy.

Nearly one in five pregnant women still smoke in the third trimester of pregnancy. This is the highest rate in Europe. Smoking during pregnancy is an established risk factor for the unborn child: risk of ectopic pregnancy, intrauterine growth restriction and prematurity, risk of sudden infant death syndrome (increased two- to threefold), and risk of respiratory problems for the newborn. The risks increase with the frequency and duration of the mother's smoking during pregnancy.

Quitting smoking is essential to prevent the risks associated with tobacco use during pregnancy. The evidence of benefits for the child from pharmacotherapeutic interventions (nicotine replacement therapy) is insufficient. New treatment options must be explored to help pregnant women quit smoking.

Financial incentives are recognized as an effective means of motivating behavior change. It is about impacting the trade-off of quitting smoking. The trade-off consists of the benefits of quitting (improved health and reduced monetary costs because tobacco is no longer purchased) and the costs of quitting (suppressing the satisfaction and pleasure derived from smoking). One consortium member conducted a large clinical trial showing that a financial incentive is an effective intervention to help pregnant women who smoke to quit smoking.

Previous studies have shown that 70% of partners of women who use tobacco are themselves smokers. The partner's smoking is a risk factor for continued tobacco use during pregnancy and can be a source of passive smoking for the mother and child. Women who quit smoking before and after pregnancy are more often in relationships with nonsmoking partners than those who continue to smoke.

The investigator hypothesize that a financial incentive aimed at the partner's abstinence from tobacco will enhance the beneficial effects of the financial incentive on reducing or stopping tobacco use during pregnancy. The investigator also hypothesize that incentivizing the partner to stop smoking will help strengthen their engagement in family life.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnant Woman Who Uses Tobacco
• Intervention / Treatment: Behavioral: Financial incentive contingent on tobacco abstinence.; Radiation: Standar care

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roxane VANSPRANGHELS-GIBERT Hospital Practitioner, MD,PhD; Phone Number: +33 320446799; Email: roxane.gibert@chu-lille.fr

Study Locations

• France
  • Haut-de-France
    • Lille, Haut-de-France, France, 59000
      • Centre Hospitalier Universitaire De Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Consent to participate in the study
• Agree to monthly prenatal follow-up at the maternity unit
• Understand French
• Are enrolled in health insurance or benefit from AME (Aide Médicale d'État)
• 18 years of age or older

Exclusion Criteria:

• Who do not wish to quit smoking
• Whose partner does not wish to quit smoking
• Who use electronic cigarettes in a complementary or exclusive manner (not applied to the partner) at inclusion
• Who will separate from the father of the unborn child and/or no longer cohabit with him
• Who will not be able to participate in the entirety of the study (e.g., planning to move after the birth of the child)
• Who do not wish to give birth in one of the study maternities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "pregnant woman and partner"; Experimental arm "pregnant woman and partner": A medical consultation will be scheduled every 4 weeks from the inclusion visit (between the 12th and 16th week of pregnancy) and until delivery. This visit will assess cigarette consumption during the previous 4 weeks. This assessment will be based on questions/answers (self-reported) and the measurement of exhaled CO. It will determine whether the pregnant woman and her partner (pregnant woman and partner arm) may be awarded a financial incentive.	Behavioral: Financial incentive contingent on tobacco abstinence.; Financial incentive conditioned on tobacco abstinence targeting the pregnant woman and the smoking partner to reduce tobacco use during pregnancy, compared with no financial incentive for the couple and with a financial incentive targeting only the pregnant woman.
Experimental: "pregnant woman"; Experimental arm "pregnant woman": A medical consultation will be scheduled every 4 weeks from the inclusion visit (between the 12th and 16th week of pregnancy) and until delivery. This visit will assess cigarette consumption during the previous 4 weeks. This assessment will be based on questions/answers (self-reported) and the measurement of exhaled CO. It will determine whether the pregnant woman (pregnant woman arm) may be awarded a financial incentive.	Behavioral: Financial incentive contingent on tobacco abstinence.; Financial incentive conditioned on tobacco abstinence targeting the pregnant woman and the smoking partner to reduce tobacco use during pregnancy, compared with no financial incentive for the couple and with a financial incentive targeting only the pregnant woman.
Active Comparator: Control arm; In the control group, parental care will follow the current practices in maternity care and the guidelines of Santé publique France in effect at the start of the study.	Radiation: Standar care; In the control group, parental care will be in line with current practices in the maternity ward and with the recommendations of Santé publique France in force at the start of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco use	Number of months the pregnant woman has abstained from smoking from enrollment (12th to 16th week) until birth.	Birth of the child

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Motivation; Tobacco; Addiction; Pregnant woman; Financial incentive; Co-parent
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior; Behavior, Addictive
• Other Study ID Numbers: 2023_0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No