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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives
Multicenter, national study. Participants are pregnant smokers of at least 18 years old, smoking at least 5 manufactured or 3 rolled-on-their-own cigarettes per day. They will be randomly assigned according to a 1:1 ratio to receive either a financial incentive (20€/visit) to attend the 5 study visits (control group) or receive this show-up incentive plus an incentive for being abstinent at visit(s) on a progressive manner (treatment group). The incentives will be delivered as vouchers. Two hundred and forty pregnant smokers will be randomized into the control and treatment groups, respectively. The study will be run in several maternity wards across France all of whom routinely treat pregnant smokers.
Expected results
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group:financial incentives | Experimental | Vouchers for show up + Vouchers at increasing amount to reward tobacco abstinence |
|
| Control group:no financial intervention | Other | Vouchers for show up only, no financial incentive for rewarding tobacco abstinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentive | Behavioral | Vouchers |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous smoking abstinence since target quit date until last visit before delivery. | Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm at all visits. | Last 6 months of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | Newborns' weight at birth | |
| 7-day point prevalence abstinence | Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm. | Last 6 months of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BERLIN Ivan, MD | Contact | 33(0)142161678 | ivan.berlin@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| BERLIN Ivan | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié-Salpétrière | Recruiting | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38485473 | Derived | Berlin I, Goldzahl L, Jusot F, Berlin N. Do smoking abstinence periods among pregnant smokers improve birth weight? A secondary analysis of a randomised, controlled trial. BMJ Open. 2024 Mar 14;14(3):e082876. doi: 10.1136/bmjopen-2023-082876. | |
| 34853024 | Derived | Berlin I, Berlin N, Malecot M, Breton M, Jusot F, Goldzahl L. Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial. BMJ. 2021 Dec 1;375:e065217. doi: 10.1136/bmj-2021-065217. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| No financial incentive |
| Other |
No financial intervention |
|
| Time to relapse to smoking | Time in days between predefined quit date and first cigarette smoked after quit date as ascertained at the presential visits and relapse confirmed by expired air CO higher than 8 ppm and self-report of smoking. | Between quit date and last visit before delivery, a maximum time frame of 6 months. |
| Craving for tobacco | 12 item French Tobacco Craving questionnaire (FTCQ12) | Last 6 months of pregnancy |
| Tobacco withdrawal symptoms | Updated Minnesota Nicotine Withdrawal Scale (NMWS) | Last 6 months of pregnancy |
| Urinary anabasine (ng/mL) | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine) | At baseline and at a randomly chosen visit before delivery |
| Urinary anatabine (ng/mL) | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake | At baseline and at a randomly chosen visit before delivery |
| Urinary cotinine (ng/mL) | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake | At baseline and at a randomly chosen visit before delivery |
| 27466239 | Derived | Berlin N, Goldzahl L, Jusot F, Berlin I. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study. BMJ Open. 2016 Jul 26;6(7):e011669. doi: 10.1136/bmjopen-2016-011669. |