RACE FIT (Phase I)
Research type
Research Study
Full title
Reducing Acquisition of CMV through antenatal Education: A feasibility study to assess an educational intervention to prevent cytomegalovirus infection in pregnancy (RACE FIT), Phase I
IRAS ID
197759
Contact name
Christine Jones
Contact email
Sponsor organisation
St George's University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Cytomegalovirus (CMV) is the most common congenital infection (an infection contracted before birth). 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 other, better known conditions such as Down’s syndrome or spina bifida. Simple hygiene measures can reduce the risk of catching CMV infection whilst pregnant and therefore also the reduce the risk of congenital infection in the infant. In the UK, pregnant women are not routinely told about these hygiene measures.
In this study, we will design an educational intervention that aims to reduce the chance of women becoming infected with CMV infection during pregnancy. We will run small discussion groups with pregnant women and their partners and interviews with families affected by CMV to develop and refine 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.
In the next phase of the study we will test this educational intervention in a feasibility study where women are assigned by chance to receive the intervention or to continue with treatment as usual. This feasibility 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 of whether this intervention can reduce CMV infections in pregnancy. This feasibility study is therefore essential to the design of a large-scale future trial.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0683
Date of REC Opinion
7 Dec 2016
REC opinion
Favourable Opinion