Extract

Background and study aims About 13% of women having babies in the Coombe Hospital smoke cigarettes. This is associated with an increased risk of having a baby weighing less than 2.5kg at birth, and of having a baby before he or she is due to be born (premature birth). Both low birth weight and preterm birth are the leading causes of health problems for babies, including failure of the baby to reach its growth potential, or even stillbirth. Smoking can lead to an increased risk of pregnancy-related problems for the mother as well, including high blood pressure or separation of the placenta from the wall of the womb, causing bleeding. It has been shown that there is a relationship between the number of cigarettes smoked per day and the amount of risk placed on the pregnancy. Stopping smoking has well-known benefits, as does “cutting down”. There is, however, no proven cost effective way to help women to cut down or stop smoking during pregnancy. The aim of this study is to assess whether receiving smoking cessation advice and social media support via a secret website is more effective than the usual way of delivering smoking cessation advice (with pamphlets at the first pregnancy visit, and through doctors). We also hope to show that smoking cessation will result in fewer pregnancies complicated by a low birthweight baby or a baby born too early. Who can participate? Pregnant women aged over 18 who smoke What does the study involve? Participants are randomly allocated to either the control group or the intervention group. The control group receive standard antenatal care in which they receive routine advice on diet, exercise and smoking cessation. The intervention group receive standard antenatal care along with an individualised counselling session and social media support via a private website. The individualised counselling session includes advice on how to quit smoking, smoking cessation resources and the benefits of smoking cessation. At the 24 weeks gestation antenatal appointment the women are also invited to join a website for smoking cessation support which includes reasons to stop smoking, methods to stop smoking and also allows for interaction between members of the group. Participants are seen by the research team once at less than 24 weeks gestation, at one other time point in pregnancy, at delivery, and 6 weeks after delivery, to have measurements (weight, height, body composition), a urine test, a breath test, and to complete food diaries and questionnaires. What are the possible benefits and risks of participating? The possible benefits of participation include increased knowledge of the health risks, adverse pregnancy outcomes and financial cost of continuing to smoke during pregnancy. There are no known adverse risks of participation. Where is the study run from? The Coombe Women and Infants University Hospital (Ireland) When is the study starting and how long is it expected to run for? June 2015 to March 2018 Who is funding the study? Coombe Women and Infants University Hospital (Ireland) Who is the main contact? Ciara Reynolds

Inclusion criteria

• Smoking cessation in pregnant women

Links

• isrctn
• ictrp