1050 pregnant women are being recruited for the most extensive trial of its kind to establish the effect of using nicotine patches during pregnancy. The £1.3m clinical trial — Smoking, Nicotine and Pregnancy (SNAP) trial - will investigate whether nicotine replacement therapy (NRT) is safe, effective and cost-effective for mums-to-be who want to give up smoking. It will also study the effect on the behaviour and development of the child.
Smoking during pregnancy is recognised as a major public health problem. Around 30% of pregnant women smoke and researchers say it can cause significant health problems in the unborn child. It accounts for around 4000 fetal deaths (including miscarriages) every year and it can lead to premature births, low birth weight, cot death and asthma. It is also associated with attention deficit and learning problems in childhood.
The trial, funded by the National Institute for Health Research’s Health Technology Assessment Programme, is being led by Dr Tim Coleman from the Division of Primary Care at The University of Nottingham. He says women are highly motivated to stop smoking when they are pregnant: “If the SNAP trial establishes that NRT is effective and safe when used for smoking cessation by pregnant women, then greater use of NRT by pregnant smokers could have a substantial impact on their health and also on the health of their babies”.
Women who attend hospital for ante-natal ultrasound scans at between 12 and 24 weeks pregnant are being offered trial participation. If they agree to take part they will receive either nicotine or placebo patches. This will be backed up with support and advice on how to deal with cravings, and what to do to avoid smoking. Their progress will be followed until their children are two years old when infants’ cognitive development and respiratory symptoms will be compared.
Smoking brings the fetus into contact not just with nicotine but with a long list of other harmful chemicals. Although there is expert consensus that NRT is probably safer than smoking the team have received funding to establish whether or not this is actually the case.
Research midwives are recruiting women to the SNAP trial at Nottingham City Hospital, Queens Medical Centre, Kings Mill Hospital in Mansfield, University Hospital of North Staffordshire in Stoke-on-Trent and the trial will begin in Crewe and Macclesfield in September. The team will be working closely with the local Stop Smoking services.
NRT can double a non-pregnant smoker’s chance of giving up, but as pregnant women metabolise nicotine a lot faster than other people it cannot be assumed that NRT will work for them and the SNAP trial will establish whether or not this is the case.
Sue Cooper, the Trial Manager, said: “This is a really interesting and challenging trial to be involved with. We’ve got a great team of enthusiastic research midwives who are working alongside local staff in the hospitals to recruit women to take part in the trial and to help support them to stop smoking”.
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Notes to editors: The University of Nottingham is Britain’s University of the Year (The Times Higher Awards 2006). It undertakes world-changing research, provides innovative teaching and a student experience of the highest quality. Ranked by Newsweek in the world’s Top 75 universities, its academics have won two Nobel Prizes since 2003. The University is an international institution with campuses in the United Kingdom, Malaysia and China.
This project was funded by the NIHR Health Technology Assessment Programme (project number 06/07/01) See the HTA Programme website for further project information.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.