BabyBreathe Trial (A randomised controlled trial of a complex intervention to prevent return to smoking postpartum)

Research question: In women who quit tobacco smoking for or during pregnancy, is the BabyBreathe intervention effective and cost-effective, in comparison with usual care, at reducing return to smoking in real world settings at long-term (12 month) postpartum follow-up? Background: 22% of UK women report smoking in the year before pregnancy. Around half quit smoking during pregnancy, but up to 76% return to smoking within 6 months. There is no routine support preventing relapse. The NHS long-term plan prioritises smoking cessation in pregnancy. This work builds on the success of women quitting in the short-term by preventing relapse to help create more long-term quitters. ‘BabyBreathe’, successfully developed by our team through an MRC PHIND project, is a complex intervention offering a combination of face to face, digital and tailored support to postpartum women. Sustained smoking abstinence has significant health benefits for mothers, minimising long-term smoking harm. Furthermore, maternal smoking is the primary source of infant/child second-hand smoke exposure and a substantial cause of child morbidity and mortality. There is an intergenerational effect: children of smoking mothers are twice as likely to smoke. The total NHS annual cost of smoking continuation, or returning to smoking following pregnancy, is estimated to be up to £64 million for maternal health problems, and inpatient care alone in children, attributable to passive smoking, costs up to £12 million in England. Aims and objectives: To undertake a randomised controlled trial (RCT), with internal pilot, comparing BabyBreathe with usual care, assessing long-term smoking abstinence for mothers who have recently given birth and have stopped smoking during pregnancy or during the 12 months prior to pregnancy. 1. To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems. 2. To definitively test real-world effectiveness of BabyBreathe in comparison with usual care, by comparing smoking abstinence at 12 month follow-up between trial groups. 3. To undertake a cost effectiveness analysis of Babybreathe in comparison with usual care based on healthcare resource use of mother and infant (from NHS, social care & broader family perspective) and health related quality of life. 4. To undertake an embedded mixed-methods process evaluation to assess delivery, implementation, fidelity and contamination, and to identify mechanisms of action by exploring which intervention components may be particularly effective, for which women, in which contexts. Methods: RCT recruiting pregnant women who quit smoking for or during pregnancy across England and Scotland, with an internal pilot, health economic evaluation and process evaluation. Timelines: Total duration 39 months: 3m study set up; 15m recruitment; 12-15m follow up (allowing 3m as randomised at 28 weeks gestation); and 6m analysis and dissemination. Anticipated impact and dissemination: we will definitively test BabyBreathe and make recommendations for future implementation, if effective. Results will be disseminated at international conferences and published in leading journals to reach academic experts, disseminated through NHS networks to reach commissioners/managers, and to members of the public via social media and public engagement events, to reach the target population of pregnant and postpartum women and their partners in need of support to stay smoke-free.