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Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? Discussion This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit. Trial registration Current Controlled Trials ISRCTN87508788

Abstract Background Over 20% of women smoke throughout pregnancy despite the known risks to mother and child. Engagement in face-to-face support is a good measure of service reach. The Scottish Government has set a target that by 2010 8% of smokers will have quit via NHS cessation services. At present less than 4% stop during pregnancy. We aimed to establish a denominator for pregnant smokers in Scotland and describe the proportion who are referred to specialist services, engage in one-to-one counselling, set a quit date and quit 4 weeks later. Methods This was a descriptive epidemiological study using routinely collected data supplemented by questionnaire information from specialist pregnancy cessation services. Results 13266 of 52370 (25%) pregnant women reported being current smokers at maternity booking and 3133/13266 (24%) were referred to specialist cessation services in 2005/6. Two main types of specialist smoking cessation support for pregnant women were in place in Scotland. The first involved identification using self-report and carbon monoxide breath test for all pregnant women with routine referral (1936/3352, 58% referred) to clinic based support (386, 11.5% engaged). 370 (11%) women set a quit date and 116 (3.5%) had quit 4 weeks later. The second involved identification by self report and referral of women who wanted help (1195/2776, 43% referred) for home based support (377/1954, 19% engaged). 409(15%) smokers set a quit date and 119 (4.3%) had quit 4 weeks later. Cost of home-based support was greater. In Scotland only 265/8062 (3.2%) pregnant smokers identified at maternity booking, living in areas with recognised specialist or good generic services, quit smoking during 2006. Conclusions In Scotland, a small proportion of pregnant smokers are supported to stop. Poor outcomes are a product of current limitations to each step of service provision - identification, referral, engagement and treatment. Many smokers are not asked about smoking at maternity booking or provide false information. Carbon monoxide breath testing can bypass this difficulty. Identified smokers may not be referred but an opt-out referral policy can remove this barrier. Engagement at home allowed a greater proportion to set a quit date and quit, but costs were higher.

Background: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit?Methods: The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, < 24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK?Discussion: This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women.Trial Registration: Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017. [ABSTRACT FROM AUTHOR]

The WHO recommends exclusive breastfeeding for 6 months, but despite interventions, breastfeeding rates remain stubbornly low. Financial voucher incentives have shown promise but require a biomarker for validation of intake. This study aimed to develop a simple biochemical assay of infant urine that would tell if an infant was receiving any breast milk to validate maternal report. Urine samples were collected and snap frozen from 34 infants attending with minor illness or feeding problems, of whom 12 infants were exclusively breastfed, nine exclusively formula fed, and 11 mixed breast/formula fed. High‐performance anion exchange chromatography was used to identify discriminating patterns of monosaccharide composition of unconjugated glycans in a sequence of three experiments. The absolute concentration of all human milk oligosaccharides measured blind could detect "any breastfeeding" only with a sensitivity of 48% and specificity of 78%. Unblinded examination of N‐acetylglucosamine (GlcNAc) measured as GlcNH2 after hydrolysis of GlcNAc improved sensitivity to 75% at the expense of a specificity of 28%. Estimation of the relative abundance of GlcNH2 (GlcNH2[%]) or the ratio of GlcNH2 to endogenous mannose (Man) improved accuracy. In a further blind experiment, the GlcNH2/Man ratio with a cut‐off of 1.5 correctly identified all those receiving "any breast milk," while excluding exclusively formula fed infants. The GlcNH2/Man ratio in infant urine is a promising test to provide biochemical confirmation of any breastfeeding for trials of breastfeeding promotion. [ABSTRACT FROM AUTHOR]

Determines the measurement on the prevalence of breast feeding and value of using information collected on Guthrie cards in Scotland. Analysis of the information collected; Measurement on the prevalence of breast feeding in the maternity units; Essence of government intervention to increase breast feeding prevalence. INSET: Clinical implications.

Background: The Cessation in Pregnancy Incentives Trial (CPIT), which offered financial incentives for smoking cessation during pregnancy showed a clinically and statistically significant improvement in cessation. However, infant birth weight was not seen to be affected. This study re-examines birth weight using an intuitive and a complier average causal effects (CACE) method to uncover important information missed by intention-to-treat analysis., Methods: CPIT offered financial incentives up to £400 to pregnant smokers to quit. With incentives, 68 women (23.1%) were confirmed non-smokers at primary outcome, compared to 25 (8.7%) without incentives, a difference of 14.3% (Fisher test, p < 0.0001). For this analysis, randomised groups were split into three theoretical sub-groups: independent quitters - quit without incentives, hardened smokers - could not quit even with incentives and potential quitters - required the addition of financial incentives to quit. Viewed in this way, the overall birth weight gain with incentives is attributable only to potential quitters. We compared an intuitive approach to a CACE analysis., Results: Mean birth weight of potential quitters in the incentives intervention group (who therefore quit) was 3338 g compared with potential quitters in the control group (who did not quit) 3193 g. The difference attributable to incentives, was 3338 - 3193 = 145 g (95% CI -617, +803). The mean difference in birth weight between the intervention and control groups was 21 g, and the difference in the proportion who managed to quit was 14.3%. Since the intervention consisted of the offer of incentives to quit smoking, the intervention was received by all women in the intervention group. However, "compliance" was successfully quitting with incentives, and the CACE analysis yielded an identical result, causal birth weight increase 21 g ÷ 0.143 = 145 g., Conclusions: Policy makers have great difficulty giving pregnant women money to stop smoking. This study indicates that a small clinically insignificant improvement in average birth weight is likely to hide an important clinically significant increase in infants born to pregnant smokers who want to stop but cannot achieve smoking cessation without the addition of financial voucher incentives., Trial Registration: ISRCTN Registry, ISRCTN87508788 . Registered on 1 September 2011.

Objective: To determine what impact reliance on self reported smoking status during pregnancy has on both the accuracy of smoking prevalence figures and access to smoking cessation services for pregnant women in Scotland., Design: Retrospective, cross sectional study of cotinine measurements in stored blood samples., Participants: Random sample (n=3475) of the 21 029 pregnant women in the West of Scotland who opted for second trimester prenatal screening over a one year period., Main Outcome Measure: Smoking status validated with cotinine measurement by maternal area deprivation category (Scottish Index of Multiple Deprivation)., Results: Reliance on self reported smoking status underestimated true smoking by 25% (1046/3475 (30%) from cotinine measurement v 839/3475 (24%) from self reporting, z score 8.27, P<0.001). Projected figures suggest that in Scotland more than 2400 pregnant smokers go undetected each year. A greater proportion of smokers in the least deprived areas (deprivation categories 1+2) did not report their smoking (39%) compared with women in the most deprived areas (22% in deprivation categories 4+5), but, because smoking was far more common in the most deprived areas (706 (40%) in deprived areas compared with 142 (14%) in affluent areas), projected figures for Scotland suggest that twice as many women in the most deprived areas are undetected (n=1196) than in the least deprived areas (n=642)., Conclusion: Reliance on self reporting to identify pregnant smokers significantly underestimates the number of pregnant smokers in Scotland and results in a failure to detect over 2400 smokers each year who are therefore not offered smoking cessation services.