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

NCT04879784 | Unknown

• 1 other identifier: RHM CHI1088
• Study Type: observational
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• The seroprevalence of CMV in sera collected in the first trimester of pregnancy

  Proportion of samples that are CMV IgG+

  31/12/2021

• The seroincidence of primary CMV infection in the first trimester of pregnancy

  Proportion of samples that are IgG+, IgM+ with low IgG avidity

  31/12/2021

Study Arms (1)

Stored antenatal sera

Antenatal sera from women booking for antenatal care at six centres in England

Other: No intervention

Interventions

No intervention OTHER

No intervention

Stored antenatal sera

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women

You may qualify if:

• Antenatal sera collected in the designated sites within the first 16 weeks of pregnancy and collected within a two-month period between 1st April 2019 and 1st October 2019 inclusive.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• St George's, University of London: collaborator
• University College, London: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• CMV Action: collaborator
• Kingston University: collaborator
• University of Cambridge: collaborator
• University of Southampton: collaborator

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 10, 2021
• Study Start: May 3, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share