An interventional study of Hygiene based educational film in Cytomegalovirus Congenital, sponsored by St George's, University of London. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by St George's, University of London · Not applicable, Interventional, and Prevention
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.
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.
359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.
This study's enrollment of 878 is above the median of 60 across 233 interventional studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →St George's, University of London is the lead sponsor of 105 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Educational intervention development
Develop and refinement of a film-based educational intervention in partnership with pregnant women and families affected by CMV
Time frame: 3 years
Proportion of women willing to be screened for CMV
Proportion of women approached who are willing to have antenatal booking blood tested for CMV antibodies to determine serostatus
Time frame: 1 year
Proportion of women seronegative at antenatal booking
Proportion of women who have no evidence of previous CMV infection at the time of antenatal booking
Time frame: 1 year
Proportion of women with primary CMV infection in the first trimester of pregnancy
Proportion of women who have evidence of primary CMV infection within the first trimester of pregnancy
Time frame: 1 year
Proportion of seronegative willing to be randomised to receive educational intervention or treatment as usual
Proportion of seronegative pregnant women willing to participate in feasibility study, which includes randomisation to the educational intervention or treatment as usual
Time frame: 1 year
Seroconversion rate
Women will have a second blood sample tested at the end of pregnancy (between 34 weeks and delivery) to determine whether seroconversion has occurred. Seroconversion is the appearance of anti-CMV IgG antibodies in the serum of a person who did not have such antibodies previously. This will be the gold standard evidence for acquisition of primary infection and is the main outcome measure of the future main trial.
Time frame: 18 months
Proportion of infants with congenital CMV
The proportion of infants with a positive test for CMV in the first 21 days of life
Time frame: 2 years
Measures of adherence
Women in the treatment arm will be asked to a questionnaire to assess their perceptions of adherence to the advice given
Time frame: 2 years
Change in knowledge
Women will complete questionnaires before and after the intervention to assess changes in knowledge about CMV
Time frame: 2 years
Knowledge of CMV risk reduction measures
Women will complete questionnaires before and after the intervention to assess changes in knowledge about risk reduction measures and self-efficacy towards these
Time frame: 2 years
Acceptability of prevention measures
Women will complete questionnaires before and after the intervention to assess the acceptability of prevention measures and to identify barriers to adherence. Interviews will also be carried out to explore these in more depth.
Time frame: 2 years
Acceptability of the educational intervention (film)
Perceptions Perceptions and acceptability of the educational intervention will be explored in questionnaires and interviews
Time frame: 2 years
Anxiety level
Women in the treatment arm will complete the Perinatal Anxiety Screening Scale and Edinburgh Depression Scale to ensure that study participation does not increase anxiety.
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St George's, University of London