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Primary Prevention of Cytomegalovirus in Pregnancy: Addressing the Gaps (CMV GAP)

NCT04879784 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 6000

Last updated 2021-05-12

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Congenital

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • St George's, University of London

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • CMV Action

    collaborator UNKNOWN

  • Kingston University

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • University of Southampton

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879784 on ClinicalTrials.gov