Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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. |
|
| "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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentive contingent on tobacco abstinence. | Behavioral | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Women who identify as women (with a uterus)
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roxane VANSPRANGHELS-GIBERT Hospital Practitioner, MD,PhD | Contact | +33 320446799 | roxane.gibert@chu-lille.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Lille | Lille | Haut-de-France | 59000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standar care | Radiation | 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. |
|
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
Not provided
Not provided