Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04879784 |
| Other study ID # |
RHM CHI1088 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 3, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital Southampton NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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, investigators will carry out a CMV serosurvey using stored antenatal serum from
pregnant women across England. Investigators will test these samples at the point at which
they would otherwise be destroyed. This will enable investigators 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 investigators to determine the proportion of women who acquire CMV in the first
trimester of pregnancy - thus demonstrating the consequences of policy inaction.
Description:
Ten children are born every day in the UK with congenital cytomegalovirus (CMV) infection.
Over half of infants who have symptoms or signs of CMV at birth have moderate to severe
long-term impairments such as hearing loss or neurodisability; of those infants who appear
well at birth, nearly 1 in 5 have long-term adverse sequalae. The impact on these families is
immense, even for those families whose child has normal hearing and development, as the
outcomes are often unpredictable at birth. The cost of CMV in the UK is around £732 million
each year.
CMV infection in healthy individuals is often asymptomatic or associated with mild flu-like
symptoms and therefore the infection may not be diagnosed in pregnancy. If a woman has a
primary CMV infection (i.e. never had CMV infection before, termed 'seronegative'), the risk
of transmission to the infant is around 32%; the risk is lower in those women who had had CMV
infection previously (CMV IgG antibodies present, termed 'seropositive'), in the order of 1%.
Acquisition of CMV infection in the first trimester of pregnancy is associated with the
highest risk of adverse outcomes for the infant.
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. For example: tasting food first and
not eating a young child's left-over food; or kissing on the forehead instead of on the lips;
handwashing after nappy changes.
Despite CMV being the most common congenital infection and the leading infectious cause of
sensorineural hearing loss and neurodisability, it is much less well known than other
conditions that occur at a lower frequency, such as Down's Syndrome.
However, the majority of antenatal care providers do not include information about CMV to
women alongside information about how to prevent other, much less common conditions, such as
toxoplasmosis. There are currently no national policies that recommend CMV risk reduction
measures in pregnancy.
Investigators are working with policy makers and other key stakeholders to identify gaps
which need to be addressed in future trials of interventions in pregnancy to reduce the risk
of CMV in pregnancy and therefore the number of infants born with congenital CMV infection.
In order to inform these discussions and future research studies, investigators need accurate
information about the proportion of women in the UK who are seronegative - that have not had
CMV before. This is because future studies will enrol seronegative women in order to
determine if an intervention (educational intervention or vaccine) is effective. Efficacy
would be measured by comparing the proportion of women who seroconvert in comparison groups
(that is the proportion of women who become seropositive during the study). It is not
possible to determine acquisition of infection by a different strain (re-infection) of CMV or
reactivation of CMV in seropositive women using currently available techniques. Such
intervention studies will need to enrol thousands of women and will be therefore require
large amounts of resourcing, so being able to accurately power these studies is essential.
There is limited data on the seroprevalence of CMV amongst women of childbearing age in the
UK.
Investigators will test stored antenatal serum from pregnant women from six sites across
England. Investigators will test these samples at the point at which they would otherwise be
destroyed, these samples would therefore not be utilised as part of clinical care.
Investigators will not seek consent for testing of these samples from individuals and no
results of blood tests will be provided to individuals. All pregnancies will be completed and
therefore the result would have no impact on the antenatal care. There is no routine
antenatal or postnatal screening done for CMV antibodies (to determine past of present
infection) in the UK.
Samples will be fully anonymised within the University Hospital Southampton NHS Foundation
Trust Specialist Virology Laboratory and tested in using routinely performed clinical
procedures by NHS staff. No research staff will be involved in the transportation, receipt or
testing of the samples. Results will be provided by NHS laboratory staff to researchers in
fully anonymised form. Therefore at no time will researchers have access to patient
identifiers on patient samples.
