Clinical trial NCT03511274: Reducing Acquisition of CMV Through Antenatal Education
Official title: Reducing Acquisition of CMV Through Antenatal Education: A Feasibility Study to Assess an Educational Intervention to Prevent Cytomegalovirus Infection in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Congenital
Keywords: Cytomegalovirus Congenital
CMV
Cytomegalovirus infections
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: University College, London
name: Kingston University
name: University of Cambridge
name: CMV Action
First posted: 2018-04-27
Enrollment: 878
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CMV seronegative pregnant women will be randomised to one of two study arms: treatment as usual or the education intervention
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Educational intervention development
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of women willing to be screened for CMV
timeFrame: 1 year
measure: Proportion of women seronegative at antenatal booking
timeFrame: 1 year
measure: Proportion of women with primary CMV infection in the first trimester of pregnancy
timeFrame: 1 year
measure: Proportion of seronegative willing to be randomised to receive educational intervention or treatment as usual
timeFrame: 1 year
measure: Seroconversion rate
timeFrame: 18 months
measure: Proportion of infants with congenital CMV
timeFrame: 2 years
measure: Measures of adherence
timeFrame: 2 years
measure: Change in knowledge
timeFrame: 2 years
measure: Knowledge of CMV risk reduction measures
timeFrame: 2 years
measure: Acceptability of prevention measures
timeFrame: 2 years
measure: Acceptability of the educational intervention (film)
timeFrame: 2 years
measure: Anxiety level
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's, University of London
Study officials:
affiliation: St George's, University of London
name: Chrissie E Jones, BMBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.