Pregnant Woman Who Uses TobaccoPREVENTNCT07528664
Assessement of a Test a Financial-incentive Program for Pregnant Women and Their Smoking Partners to Reduce Smoking During Pregnancy.
A study testing Financial incentive contingent on tobacco abstinence. and Standar care in people with Pregnant Woman Who Uses Tobacco, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnant Woman Who Uses Tobacco
- What is being tested?
- Financial incentive contingent on tobacco abstinence. and Standar care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roxane VANSPRANGHELS-GIBERT Hospital Practitioner, MD,PhD contact
France1 site
Centre Hospitalier Universitaire de Lille
Lille, Haut-de-France, 59000
About this study
Official title: 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.
Read more
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.
- Conditions
- Pregnant Woman Who Uses Tobacco
- Being tested
- Financial incentive contingent on tobacco abstinence., Standar care
- Keywords
- Pregnant woman, Co-parent, Tobacco, Addiction, Financial incentive, Motivation
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentive contingent on tobacco abstinence.Behavioural
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.
Standar careRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| "pregnant woman and partner" | Experimental | 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. Receives: Behavioral: Financial incentive contingent on tobacco abstinence. |
| "pregnant woman" | Experimental | 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. Receives: Behavioral: Financial incentive contingent on tobacco abstinence. |
| Control arm | Active comparator | 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. Receives: Radiation: Standar care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use
Number of months the pregnant woman has abstained from smoking from enrollment (12th to 16th week) until birth.
Measured: Birth of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Woman Who Uses TobaccoStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528664
- Sponsor's protocol ID
- 2023_0280
- Acronym
- PREVENT
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07528664
- Acronym / sponsor ID
- PREVENT / 2023_0280
- Conditions
- Pregnant Woman Who Uses Tobacco
- Keywords
- Pregnant woman, Co-parent, Tobacco, Addiction, Financial incentive, Motivation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "pregnant woman and partner" | Experimental | Behavioral: Financial incentive contingent on tobacco abstinence.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. |
| "pregnant woman" | Experimental | Behavioral: Financial incentive contingent on tobacco abstinence.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. |
| Control arm | Active comparator | Radiation: Standar careIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | "pregnant woman and partner", "pregnant woman" |
| Standar careIn 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. | Radiation | Control arm |
Primary outcome
Tobacco use
Time frame: Birth of the child
Number of months the pregnant woman has abstained from smoking from enrollment (12th to 16th week) until birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roxane VANSPRANGHELS-GIBERT Hospital Practitioner, MD,PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentive contingent on tobacco abstinence. and Standar care in people with Pregnant Woman Who Uses Tobacco, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxane VANSPRANGHELS-GIBERT Hospital Practitioner, MD,PhD (+33 320446799, roxane.gibert@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco use (time frame: Birth of the child). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.