Coombe Women & Infants University Hospital, Cork Street, Dublin 8, Ireland.
Royal College of Surgeons in Ireland, 123 St Stephen's Green, Dublin 2, Ireland.
Trials. 2019 Sep 3;20(1):550. doi: 10.1186/s13063-019-3653-4.
Cigarette 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.
This 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.
The 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.
Despite 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.
ISRCTN11214785 . Registered on 8 February 2018.
吸烟会对母婴健康产生负面影响。戒烟是少数几种能够改善妊娠结局的干预措施之一。尽管存在风险，但对于吸烟者来说，最有效的产前护理模式仍不清楚，也没有针对胎儿生长受限的具体筛查建议。
这是一项关于专门的戒烟诊所与常规产前护理作为减少吸烟行为的干预措施的实用性随机对照试验。随机分配到戒烟通过优化妊娠临床护理（STOP）诊所的吸烟母亲将由一个由产科医生、助产士和戒烟从业者组成的团队提供所有产前护理。该干预措施包括对胎儿生长受限进行超声筛查。对照组包括两组：一组接受标准护理，对胎儿生长受限进行超声筛查；另一组仅在其医疗保健提供者临床指示下对生长受限进行超声筛查。将招募 450 名妇女，并按年龄、产次和胎儿生长受限史分层随机分配到干预组或对照组。
主要结局是自我报告的、在戒烟日期和妊娠结束之间连续戒烟，通过呼出的一氧化碳或尿中可替宁进行验证。戒烟日期的目标是在 16 周妊娠或之前，不超过 28 周妊娠。次要结局是一组变量，包括母婴发病率和死亡率、新生儿并发症和分娩结局、吸烟和心理结局以及定性测量。
尽管对妊娠期间吸烟进行了大量研究，但这些妇女的最佳护理模式仍不清楚。这项研究有可能改善为吸烟孕妇提供的产前护理模式，并改善母婴的结局。
ISRCTN8571463。于 2018 年 2 月 8 日注册。
Zotero 插件