CMV GAP
Research type
Research Study
Full title
Primary Prevention of Cytomegalovirus in Pregnancy: Addressing the Gaps
IRAS ID
295780
Contact name
Christine Jones
Contact email
Sponsor organisation
University Hospitals Southampton NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
CMV is the most common congenital infection (an infection acquired before birth) in the UK. It is the leading non-genetic cause of sensorineural (inner ear) hearing loss and a common cause of neuro-disability. Congenital CMV is associated with an estimated cost of £732 million each year in the UK.
The risk of acquiring CMV in pregnancy may be reduced by making simple adaptions to behaviours to avoid direct contact with saliva and urine of young children. There are currently no national policies that recommend CMV risk reduction measures in pregnancy.
The overarching aim of project is to establish and build effective partnerships with policy makers and stakeholders to identify policy priorities and to gather the essential evidence required to fully inform policies to reduce the risk of CMV infection in pregnancy.
The specific objective of this element of the overall project is to determine the proportion of women at risk of primary CMV infection in pregnancy and the rates of primary CMV infection in the first trimester of pregnancy by testing blood samples routinely collected at antenatal booking at representative sites in England.
In partnership with University Hospital Southampton NHS Foundation Trust Specialist Virology Laboratory, we will carry out a CMV serosurvey using stored antenatal serum from pregnant women across England. We will test these samples at the point at which they would otherwise be destroyed. 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 – thus demonstrating the consequences of policy inaction.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
21/ES/0067
Date of REC Opinion
24 Jun 2021
REC opinion
Favourable Opinion