Abstract
BackgroundCigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Despite the risks, the most effective antenatal model of care for smokers is still unclear, and specific recommendations for screening for fetal growth restriction are absent.MethodsThis is a pragmatic randomised controlled trial of a dedicated smoking cessation clinic versus routine antenatal care as an intervention to reduce cigarette smoking behaviour. Smoking mothers randomised to the Smoking cessation Through Optimisation of clinical care in Pregnancy (STOP) clinic will have all antenatal care provided by a team comprising an obstetrician, a midwife, and a smoking cessation practitioner. This intervention includes ultrasound screening for fetal growth restriction. The control arm comprises two groups: one receiving standard care with ultrasound screening for fetal growth restriction, and one receiving standard care with ultrasound screening for growth restriction only if clinically indicated by their healthcare provider. Four hundred and fifty women will be recruited and randomised to either intervention or control arms stratifying for age, parity, and history of fetal growth restriction.ResultsThe primary outcome is self-reported, continuous abstinence from smoking between the quit date and end of pregnancy, validated by exhaled carbon monoxide or urinary cotinine. The quit date is targeted as being at or before 16 weeks’ gestation and no further than 28 weeks’ gestation. The secondary outcomes are a set of variables including maternal and fetal morbidity and mortality, neonatal complications and delivery outcomes, smoking and psychological outcomes, and qualitative measures.ConclusionsDespite much research into cigarette smoking in pregnancy, the optimal model of care for these women is still unknown. This study has the potential to improve the model of antenatal care provided to pregnant women who smoke and to improve outcomes for both mother and infant.Trial registrationISRCTN11214785. Registered on 8 February 2018.
Highlights
Cigarette smoking negatively impacts on maternal and fetal health
The clinic is the intervention, rather than a single specific psychological or pharmacological intervention. Study design This is an ongoing single-centre pragmatic randomised controlled trial (RCT) which commenced in February 2018
The study is registered with the International Standard Randomised Controlled Trial Number clinical trial registry (ISRCTN 11214785)
Summary
Cigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Smoking in pregnancy is a risk factor associated with poor maternal and fetal outcome. It remains a significant cause of morbidity and mortality for both mother and baby. Smoking is associated with low birth weight, miscarriage, placental abruption, pre-term birth, and neonatal morbidity and mortality. Smoking during pregnancy is associated with long-term consequences for the child in terms of neurological development, endocrine dysfunction, and oncogenesis [1]. Children of smokers are twice as likely to smoke themselves later in life [4]
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