Preventing Return to Smoking Postpartum (PReS Study) - Development of a complex intervention to sustain smoking cessation in postpartum women

This study aims to develop a supportive intervention to help women who have stopped smoking in pregnancy to stay stopped following the birth of a baby.

Approximately a quarter of women in the UK report smoking in the 12 months before pregnancy. Over half of these women manage to quit during pregnancy. However, most women re-start smoking again after their babies are born. This can severely affect the health of the mother, and the baby. Smoking is the leading preventable cause of death in adults, causing 80% of deaths from lung cancer and bronchitis. Babies exposed to 'second-hand smoke' (passive smoking) have higher risks of cot death and suffering from breathing problems and ear infections.

Our team of leading experts in this specific research area will conduct this study. As this study is 'intervention development', it is the first step in developing and initially testing out an approach to helping women to remain smoke free following pregnancy. Although our expert group have been involved in a programme of research work leading up to this point, there are currently no proven effective approaches to helping women to remain smoke-free after childbirth. We will build upon existing evidence by specifically identifying what approaches might best help women to remain smoke free after their babies are born. We will collate and review key findings from scientific studies to identify the best possible approaches and the best timing for support to be provided. We will then gather the views of women, their partners and health professionals in discussion groups to develop and refine elements of an 'intervention' to help women. This is likely to include medication, electronic cigarette use, specialist behavioural support, social support and incentives to remain smoke free. We will also explore ways to deliver the intervention in our discussion groups by finding out whether women prefer online or digital support or to be supported face-to-face, perhaps combining approaches. We will initially test out components of the intervention by working closely with approximately ten individual women who have quit smoking during pregnancy. Finally, we will test the best timing for the intervention, through combining the evidence and our own research findings to determine when the intervention should be delivered and for how long support should continue.

The outcome of our development work will be a defined intervention ready for testing in a larger research trial. We will communicate our ongoing research findings throughout the study via social media (Facebook and Twitter). At the end of the study, we will present our research findings to patients, the public, and professionals delivering care to women. We will use all our professional contacts to ensure our research has an impact on policy and practice. We will also publish our findings in academic journals.

In the UK 26% of women smoked tobacco in the 12 months before pregnancy (1). Although 54% of smokers quit during pregnancy, 94% of those re-start smoking by 6 months postpartum (5). Continued postpartum abstinence has major health benefits, as many of the risks attributable to smoking, including cancer and heart disease, can be minimised by cessation. Abstinence also reduces children's exposure to second hand smoke, with associated risks including respiratory conditions and cot death (7, 8). In 2015, the UK Royal College of Physicians (9) estimated passive smoking in children had an avoidable annual NHS cost of approximately £23.3 million. This study aims to develop a novel intervention to support women who have stopped smoking in pregnancy to stay stopped in the postpartum period. In phase 1, we will collate evidence from systematic reviews undertaken by our team (15, 25) and other studies to identify suitable intervention components and the underlying theoretical processes of change (behaviour change techniques, BCTs). Promising components are likely to include goal setting, incentives for continued cessation, advice on medication, and social support specifically tailored to postpartum status. The intervention will be developed and refined during phase 2 which involves focus groups with pregnant and post-partum women (smokers and ex-smokers), their partners, healthcare and stop smoking professionals. Focus groups will refine intervention content through discussion, and define procedures for delivery of the intervention, (e.g. brief intervention by a healthcare professional then online, or text message support). In phase 3, we will model the intervention to test it out and further refine it. This modelling phase will confirm the optimal and achievable procedures for delivery, exploring tailored dose and targeting. The output of the study will be the development of a new intervention suitable for further testing in a clinical trial.