Title: Reducing Acquisition of CMV through antenatal Education: A feasibility study to assess an educational intervention to prevent cytomegalovirus infection in pregnancy (RACE FIT)
Funder: Department of Health and Social Care

Abstract: Background Cytomegalovirus (CMV) is the most common congenital infection in the UK. Up to 15% of CMV-infected infants have symptoms at birth and most of these infants (40-60%) will experience permanent health problems, such as cerebral palsy, cognitive impairment and sensorineural hearing loss (SNHL). Of those infants who are initially asymptomatic, 10-15% develop long-term sequelae, particularly SNHL. Despite the burden of adverse health outcomes, most pregnant women are not aware of CMV or the simple measures that can be taken to prevent it. Advice about avoidance of CMV infection is not routinely offered in the NHS. There is no licensed CMV vaccine and no routine treatment of antenatal CMV in the NHS. However, 3 published and 1 unpublished studies show that the risk of acquiring infection might be reduced through educational interventions and that such preventative measures are acceptable. None of these studies have been carried out within the NHS and have been small or non-randomised. A large scale RCT is needed to verify their results and determine the feasibility of this approach in the NHS. Aims We aim to develop educational materials in partnership with patients to encourage pregnant women to adopt behaviours to reduce the risk of antenatal acquisition of CMV. We aim to carry out a feasibility study to generate essential data to inform the design of the future main randomised controlled trial (RCT). The feasibility study will determine rates of uptake of screening, participation and adherence, establish the current seroprevalence and assess the standard deviation of the outcome measure of the future main trial (antenatal acquisition of primary CMV infection). Plan of investigation Phase I A film-based educational intervention will be co-designed with pregnant women and families affected by congenital CMV in focus groups, using psychological models of behavioural change. Phase II In the feasibility study we will focus on women at increased risk of CMV infection (as a result of having children already) who book for antenatal care at St George s Hospital. Their routine booking blood sample will be tested for CMV. Seronegative women (CMV IgG antibody negative; no evidence of previous CMV infection) will be invited to continue with the study and be randomised to either the educational intervention or continue with treatment as usual. Consenting women will log onto a website using individual log in details. They will fill in a questionnaire before and after the intervention and view the educational film (treatment as usual group will receive routine information about antenatal vaccinations). Adherence to the preventative measures will be assessed using diary cards. A second sample of blood collected at the end of pregnancy will be tested to determine whether seroconversion has occurred. Infants of mothers who have seroconverted will be referred for testing for congenital CMV. Acceptability of the intervention to pregnant women and Health Care Professionals will be assessed. Summary The evidence to date indicates that educational strategies may be effective at reducing antenatal CMV infection, however these have not been tested in the UK. We will carry out a feasibility study to generate the data required for the design of a future main RCT. Should the future main RCT show that the educational intervention is effective in reducing the risk of primary CMV infection in pregnancy, the intervention could be rolled out to all pregnant women in the NHS. This would have significant benefits to both patients and the NHS. No other single cause of congenital defects and long-term developmental disability currently provides greater opportunity for improved outcomes than the prevention of congenital CMV, therefore trials designed to test prevention strategies should be a research priority for the NHS.

Lay abstract: Cytomegalovirus (CMV) is the most common infection to be contracted before birth (a congenital infection); overall, about 20% of babies infected in this way have permanent health problems, such as hearing loss, learning delay or physical impairments. CMV is not a well-known infection, despite the health problems it can cause. It is actually more common than Down s syndrome or spina bifida. Simple hygiene measures may reduce the risk of catching CMV infection whilst pregnant and therefore also the risk of congenital infection. In the UK, pregnant women are not routinely told about these hygiene measures. Before we can embark on a large-scale study in the UK to determine the effectiveness of an educational intervention in reducing CMV infection in pregnancy, we need to develop educational material and test the feasibility of such a large study. In this feasibility study we will work with pregnant women and families affected by CMV to design and produce a short film appropriate for use in the NHS to educate women about these simple hygiene measures. Working in partnership with members of the public will help us ensure the content is relevant, clear and sensitive. We will use this film in a study where women are assigned by chance to the educational intervention or to continue with treatment as usual with information about vaccines already recommended within the NHS. This ensures both groups will get some benefit from the study. This study will enable us to work out the number of pregnant women who are at risk of contracting CMV, how many of these women would agree to take part and to calculate the number of people needed in a future main trial in order to come to a reliable answer. This feasibility study is therefore essential to the design of a large-scale future trial.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: INFECTION;REPRODUCTIVE HEALTH AND CHILDBIRTH