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Not yet recruitingNCT07528664PREVENTUpdated Apr 14, 2026

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

An interventional study of Financial incentive contingent on tobacco abstinence. and Standar care in Pregnant Woman Who Uses Tobacco, sponsored by University Hospital, Lille. Not yet recruiting at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pregnant Woman Who Uses Tobacco

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Keywords

  • Pregnant woman
  • Co-parent
  • Tobacco
  • Addiction
  • Financial incentive
  • Motivation
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • 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.

  • 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.

  • 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

Interventions

  • BehavioralFinancial 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.

  • RadiationStandar 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.

05

What researchers measure

Primary outcomes

  1. Tobacco use

    Number of months the pregnant woman has abstained from smoking from enrollment (12th to 16th week) until birth.

    Time frame: Birth of the child

06

Study locations

1 site
  • Centre Hospitalier Universitaire de Lille
    Lille, Haut-de-France 59000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07528664
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Apr 14, 2026

Study contacts

Roxane VANSPRANGHELS-GIBERT Hospital Practitioner, MD,PhD
Contact
roxane.gibert@chu-lille.fr
+33 320446799

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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