Reducing Acquisition of CMV Through Antenatal Education

NCT03511274 | Completed

• 1 other identifier: PB-PG-0215-36120
• Study Type: interventional
• Target: 878
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Congenital

Keywords

Cytomegalovirus Congenital; CMV; Cytomegalovirus infections

Outcome Measures

Primary Outcomes (1)

• Educational intervention development

  Develop and refinement of a film-based educational intervention in partnership with pregnant women and families affected by CMV

  3 years

Secondary Outcomes (12)

• Proportion of women willing to be screened for CMV

  1 year

• Proportion of women seronegative at antenatal booking

  1 year

• Proportion of women with primary CMV infection in the first trimester of pregnancy

  1 year

• Proportion of seronegative willing to be randomised to receive educational intervention or treatment as usual

  1 year

• Seroconversion rate

  18 months

Study Arms (2)

Hygiene based educational film

EXPERIMENTAL

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.

Behavioral: Hygiene based educational film

Treatment as usual (TAU)

NO INTERVENTION

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.

Interventions

Hygiene based educational film 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.

Hygiene based educational film

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St George's, University of London: lead
• University College, London: collaborator
• Kingston University: collaborator
• University of Cambridge: collaborator
• CMV Action: collaborator

Study Sites (1)

St George's, University of London

London, SW17 0RE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34407771 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Chrissie E Jones, BMBS PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Senior Lecturer & Consultant in Paediatric Infectious Diseases

Model Details: CMV seronegative pregnant women will be randomised to one of two study arms: treatment as usual or the education intervention

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: April 27, 2018
• Study Start: January 17, 2017
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)