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 1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers; 2. To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention; 3. To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.
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 * Financial incentives rewarding progressive abstinence from smoking will increase abstinence rate more than lack of financial incentives. * Forward looking and time consistent women will be more likely to stop smoking. * If the clinical efficacy and cost effectiveness are demonstrated, financial incentives can be introduced as a standard intervention in helping pregnant smokers quit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
Vouchers
No financial intervention
Groupe Hospitalier Pitié-Salpétrière
Paris, France
RECRUITINGContinuous 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.
Time frame: Last 6 months of pregnancy
Birth weight
Time frame: Newborns' weight at birth
7-day point prevalence abstinence
Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm.
Time frame: Last 6 months of pregnancy
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.
Time frame: 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)
Time frame: Last 6 months of pregnancy
Tobacco withdrawal symptoms
Updated Minnesota Nicotine Withdrawal Scale (NMWS)
Time frame: Last 6 months of pregnancy
Urinary anabasine (ng/mL)
Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine)
Time frame: At baseline and at a randomly chosen visit before delivery
Urinary anatabine (ng/mL)
Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake
Time frame: At baseline and at a randomly chosen visit before delivery
Urinary cotinine (ng/mL)
Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake
Time frame: At baseline and at a randomly chosen visit before delivery
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