Pregnancy, Smoking
Conditions
Keywords
Pregnant smokers, smoking cessation, financial incentives, control group, randomized study
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFinancial incentive
Vouchers
No financial intervention
Sponsors
National Cancer Institute, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women 2. At least 18 years old 3. Smoking at least 5 manufactured cigarettes or 3 rolled-on-your-own cigarettes 4. Of \<18 weeks of gestation 5. Motivated to quit smoking 6. Affiliated to social security system 7. And who signed the written informed consent form
Exclusion criteria
1. Psychiatric disorders 2. Use of other tobacco products (pipe, cigar, oral tobacco) than cigarettes 3. Use of bupropion or varenicline 4. Use of electronic cigarettes during the current pregnancy 5. Women already included in a biomedical research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous smoking abstinence since target quit date until last visit before delivery. | Last 6 months of pregnancy | Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm at all visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence | Last 6 months of pregnancy | Self-report of no smoking confirmed by expired air carbon monoxyde ≤8 ppm. |
| Time to relapse to smoking | Between quit date and last visit before delivery, a maximum time frame of 6 months. | 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. |
| Craving for tobacco | Last 6 months of pregnancy | 12 item French Tobacco Craving questionnaire (FTCQ12) |
| Birth weight | Newborns' weight at birth | — |
| Urinary anabasine (ng/mL) | At baseline and at a randomly chosen visit before delivery | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake (cotinine) |
| Urinary anatabine (ng/mL) | At baseline and at a randomly chosen visit before delivery | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake |
| Urinary cotinine (ng/mL) | At baseline and at a randomly chosen visit before delivery | Biological markers of tobacco use (anabasine, anatabine) or nicotine uptake |
| Tobacco withdrawal symptoms | Last 6 months of pregnancy | Updated Minnesota Nicotine Withdrawal Scale (NMWS) |
Countries
France
Contacts
Primary ContactBERLIN Ivan, MD
Outcome results
None listed