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Objective To evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers. Design Single blind, randomised controlled trial. Setting Financial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France. Participants 460 pregnant smokers aged at least 18 years who smoked ≥5 cigarettes/day or ≥3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229). Interventions Participants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits. Main outcome measures The main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome—a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death. Results Mean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=−1.81, 95% confidence interval −3.55 to −0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution. Conclusions Financial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking. Trial registration ClinicalTrials.gov NCT02606227 .

IntroductionMaternal smoking during pregnancy is associated with adverse perinatal and postnatal health outcomes. The efficacy of nicotine replacement therapies in helping pregnant smokers to quit is not clearly demonstrated; therefore new interventions should be proposed and assessed. Financial incentives rewarding abstinence from tobacco smoking is one of the promising options.ObjectiveTo assess the efficacy of financial incentives on smoking abstinence among French pregnant smokers.Methods and analysisParticipants: pregnant smokers aged ≥18 years, smoking at least five manufactured or three roll-your-own cigarettes per day, and pregnant for <18 weeks of amenorrhoea (WA). Setting: participants will be recruited, included and followed-up at monthly face-to-face visits in 16 maternity wards in France. Interventions: participants will be randomised to a control or an intervention group. After a predefined quit date, participants in the control group will receive €20 vouchers at the completion of each visit but no financial incentive for smoking abstinence. Participants in the intervention group will be rewarded for their abstinence by vouchers on top of the €20 show-up fee. The amount of reward for abstinence will increase as a function of duration of abstinence to stimulate longer periods of abstinence. Main outcome measure: complete abstinence from quit date to the last predelivery visit. Secondary outcome measures: point prevalence abstinence, time to relapse to smoking, birth weight, fetal growth restriction, preterm birth. Main data analysis: outcomes will be analysed on an intention-to-treat (ITT) basis. The ITT population is defined as all randomised smoking pregnant women.Ethics and disseminationThe research protocol was approved by the ethics committee (Comité de Protection des Personnes, CPP) of the Pitié-Salpêtrière Hospital on 15 May 2015, and Amendment No 1 was approved on 13 July 2015. Results will be presented at scientific meetings and published.Trial registration numberNCT02606227; Pre-results.

A substantial amount of research has been conducted on financial incentives to increase abstinence from smoking among pregnant smokers. If demonstrated to be effective, financial incentives could be proposed as part of health care interventions to help pregnant smokers quit. Public acceptability is important; as such interventions could be publicly funded. Concerns remain about the acceptability of these interventions in the general population. We aimed to assess the acceptability of financial incentives to reward pregnant smokers who stop smoking using a survey conducted in the UK and then subsequently in France, two developed countries with different cultural and social backgrounds. More French than British respondents agreed with financial incentives for rewarding quitting smoking during pregnancy, not smoking after delivery, keeping a smoke-free household, health service payment for meeting target and the maximum amount of the reward. However, fully adjusted models showed significant differences only for the two latter items. More British than French respondents were neutral toward financial incentives. Differences between the representative samples of French and British individuals demonstrate that implementation of financial incentive policies may not be transferable from one country to another.Electronic supplementary materialThe online version of this article (doi:10.1007/s10198-017-0914-6) contains supplementary material, which is available to authorized users.