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Reducing Acquisition of CMV Through Antenatal Education

NCT03511274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2021-03-17

No results posted yet for this study

Summary

The evidence to date indicates that educational strategies may be effective at reducing antenatal CMV infection, however these have not been tested in the UK.

In phase 1 of the study, the investigators will co-design an educational intervention with pregnant women and families affected by congenital CMV with the aim of reducing the risk of acquisition of CMV in pregnancy. In phase 2 of the study, the investigators will use this educational intervention in a randomised controlled trial (RCT) as part of a feasibility study to generate the data required for the design of a future main RCT. Should the future main RCT show that the educational intervention is effective in reducing the risk of primary CMV infection in pregnancy, the intervention could be rolled out in the National Health Service (NHS). This would have significant benefits to patients and the NHS. No other single cause of congenital defects and long-term developmental disability currently provides greater opportunity for improved outcomes than the prevention of congenital CMV, therefore trials designed to test prevention strategies should be a research priority for the NHS.

Conditions

  • Cytomegalovirus Congenital

Interventions

BEHAVIORAL

Hygiene based educational film

Pregnant women will watch an educational film to increase the awareness of CMV, encourage the adoption of risk reduction behaviours and preventative strategies. The film will include women's views of the risks of CMV infection in pregnancy and how they adopted the preventative strategies.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Kingston University

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • CMV Action

    collaborator UNKNOWN

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Chrissie E Jones, BMBS PhD · St George's, University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2020-07-31
Completion
2020-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT03511274 on ClinicalTrials.gov