Title: Primary prevention of cytomegalovirus in pregnancy: addressing the gaps
Funder: Department of Health and Social Care

Abstract: Ten children are born every day with congenital cytomegalovirus (CMV) infection. CMV is the most common congenital infection in the UK and the leading non-genetic cause of sensorineural hearing loss and a common cause of neurodisability. Acquisition of CMV infection in the first trimester of pregnancy is associated with the highest risk of adverse outcomes for the infant. However, the risk of acquiring CMV in pregnancy can be reduced by making simple adaptions to behaviours to avoid direct contact with saliva and urine of young children - who are the most common transmitters of CMV infection to pregnant women. There are currently no national policies that recommend CMV risk reduction measures in pregnancy and most women are not routinely told about CMV as part of routine antenatal care. Our NIHR-funded study &ndash; Reducing acquisition of CMV in pregnancy (RACE-FIT) &ndash; has shown that pregnant women are highly motivated and willing to engage in CMV risk reduction measures and express disappointment and anger that they are not told about CMV in pregnancy. We have developed an educational film to inform and empower women to make in behavioural adaptions. We are currently testing this educational film in a feasibility study. Preliminary feedback indicates it is highly acceptable to women and increases engagement with CMV. Now is the time to work with policy makers and other key stakeholders to identify gaps which need to be addressed in future trials, and actions that need to be taken, in order to update antenatal policies to integrate CMV risk reduction measures into routine antenatal care. The aim of the project is to establish and build effective partnerships with policy makers and stakeholders to identify policy priorities and gather evidence needed to inform policies to reduce the risk of CMV infection in pregnancy. We will do this by engaging with policy makers and key stakeholders in a Policy Roundtable meeting, with a subsequent Delphi consensus process, to agree on gaps and actions that need to be taken to ensure our future research is optimally designed to address the policy gaps identified. We will carry out a CMV serosurvey using stored antenatal serum from pregnant women across England. This will enable us to determine the proportion of women who are seronegative, as this is the group that will be enrolled in future intervention studies (both educational and also vaccine studies). This information is required to accurately inform the power calculation for large efficacy studies. This will also allow us to determine the proportion of women who acquire CMV in the first trimester of pregnancy &ndash; thus demonstrating the consequences of policy inaction. Our third workstream is to evaluate the ways of implementing, sustaining or enhancing CMV educational intervention in real-world routine antenatal care settings and to explore the feasibility of conducting a future large implementation study. Now is the time to engage with policy makers to ensure that women have the advice they need to protect them and their unborn children from CMV infection.

Lay abstract: Ten children are born every day with congenital cytomegalovirus (CMV) infection. When CMV is caught before birth, particularly when the organs are still developing in early pregnancy, it can cause deafness and affect the child s physical and mental development. Congenital CMV also has significant implications for the NHS &ndash; with estimated costs of &pound;732 million each year. Despite being the most common infection that is caught before birth - and the potentially devasting consequences of CMV - most people have not heard of CMV. Many women have heard about ways to prevent other rare infections &ndash; for example avoiding cat litter and soft cheese - but never been told about ways to avoid CMV. Our research has shown that pregnant women and families affected by CMV express shock and anger about not being told about CMV. Pregnant women most commonly catch CMV from their own toddlers, through direct contact with infected saliva or urine - for example through kissing on the lips or eating left-over food on their child s plate. Small adaptions to behaviour whilst pregnant can reduce the risk of catching CMV. There are no national policies or recommendations about how to reduce the risk of catching CMV whilst pregnant and therefore this information is not routinely given to pregnant women in the NHS. In our currently funded study, we have developed, and are now testing, a short educational film with the aim that this could be used as part of routine antenatal care in the NHS. Now we need to engage with policy makers and other key stakeholders to work out the gaps that need to be filled in order for all pregnant women to be told about ways to reduce the risk of catching CMV whilst pregnant and to have a clear action plan to fill these gaps. We will do this through discussion meetings with policy makers and key stakeholders to achieve consensus on the way forward to make provision of education about CMV a reality for all pregnant women in the NHS. Through testing routinely collected and stored blood samples collected at antenatal booking appointments, we will find out the numbers of women who catch CMV early in pregnancy, as we just don t have this information at the moment. This will show the burden of CMV that we could potentially prevent as a result of policy action and the women we are failing by policy inaction. We will explore ways to meaningfully integrate information about CMV into routine antenatal care, to ensure we don t overload women themselves or the midwives and obstetricians caring for them. We will involve and consult members of the public at all stages to ensure relevance and acceptability of our activities.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INFECTION;REPRODUCTIVE HEALTH AND CHILDBIRTH