Reducing Acquisition of CMV Through Antenatal Education

NCT ID: NCT03511274

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 878 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2020-11-30

Brief 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.

Detailed Description

Cytomegalovirus (CMV) is the most common infection to be contracted before birth (a congenital infection); 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 Down's syndrome or spina bifida. Simple hygiene measures may reduce the risk of catching CMV infection whilst pregnant and therefore also the risk of congenital infection in the infant. In the UK, pregnant women are not routinely counselled about these hygiene measures.

Before a large-scale study can be performed in the UK to determine the effectiveness of an educational intervention in reducing CMV infection in pregnancy, educational materials need to be developed and tested to ensure the feasibility of such a large study.

In this feasibility study, the investigators will work with pregnant women and families affected by CMV to design and produce a short film appropriate for use in the NHS to educate women about these simple hygiene measures (phase 1 of the study). Working in partnership with members of the public will help us ensure the content is relevant, clear and sensitive.The film will subsequently be tested in a study where women are assigned by chance to the educational intervention or to continue with treatment as usual with information about vaccines already recommended within the NHS. This ensures both groups will get some benefit from the study.

This study will enable the investigators 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. This feasibility study is therefore essential to the design of a large-scale future trial.

Conditions

Cytomegalovirus Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hygiene based educational film

Women randomised to receive the CMV educational intervention will fill in a questionnaire and view the film. The website will also contain interactive information about CMV and how to prevent it. After watching the film and reading the information, women will be asked to fill in a post-intervention questionnaire. The website will be accessible via the participants' own mobile device or computer or dedicated study tablets or computers on-site. Using a web-based intervention, we will be able to monitor use of the educational intervention and also collect data in real time.

Group Type: EXPERIMENTAL

Hygiene based educational film

Intervention Type: BEHAVIORAL

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.

Treatment as usual (TAU)

Women who are randomised to the TAU group will also be asked to log-on the website. Instead of receiving specific information about prevention of CMV in pregnancy, they will receive information about routine antenatal immunisation. In the UK, the Department of Health recommends that all pregnant women should be offer immunisation against pertussis (whooping cough) and influenza (if pregnant during the influenza session). This will ensure that participants in the TAU arm of the study also derive benefit from the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant women who have children less than 3 years of age booking to St George's Hospital antenatal clinics

Exclusion Criteria

• Unwilling or unable to give informed consent
• Unwilling or unable to commit to study procedures
• Less than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Kingston University

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: collaborator

CMV Action

UNKNOWN

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Christine Jones

Honorary Senior Lecturer & Consultant in Paediatric Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chrissie E Jones, BMBS PhD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

St George's, University of London

London, , United Kingdom

Countries

United Kingdom

References

Calvert A, Vandrevala T, Parsons R, Barber V, Book A, Book G, Carrington D, Greening V, Griffiths P, Hake D, Khalil A, Luck S, Montague A, Star C, Ster IC, Wood S, Heath PT, Jones CE. Changing knowledge, attitudes and behaviours towards cytomegalovirus in pregnancy through film-based antenatal education: a feasibility randomised controlled trial of a digital educational intervention. BMC Pregnancy Childbirth. 2021 Aug 18;21(1):565. doi: 10.1186/s12884-021-03979-z.

Reference Type: DERIVED

PMID: 34407771 (View on PubMed)

Other Identifiers

PB-PG-0215-36120

Identifier Type: -

Identifier Source: org_study_id