Reducing Acquisition of CMV Through Antenatal Education

Cytomegalovirus Congenital Clinical Trial

— RACEFIT  

Official title:

Reducing Acquisition of CMV Through Antenatal Education: A Feasibility Study to Assess an Educational Intervention to Prevent Cytomegalovirus Infection in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511274
• Other study ID #: PB-PG-0215-36120
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: November 2020

Study information

• Verified date: March 2021
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 878
• Est. completion date: November 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus Congenital
• Cytomegalovirus Infections

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	St George's, University of London	London

Sponsors (5)

Lead Sponsor	Collaborator
St George's, University of London	CMV Action, Kingston University, University College, London, University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 year
Secondary	Proportion of women seronegative at antenatal booking	Proportion of women who have no evidence of previous CMV infection at the time of antenatal booking	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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.	18 months
Secondary	Proportion of infants with congenital CMV	The proportion of infants with a positive test for CMV in the first 21 days of life	2 years
Secondary	Measures of adherence	Women in the treatment arm will be asked to a questionnaire to assess their perceptions of adherence to the advice given	2 years
Secondary	Change in knowledge	Women will complete questionnaires before and after the intervention to assess changes in knowledge about CMV	2 years
Secondary	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	2 years
Secondary	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.	2 years
Secondary	Acceptability of the educational intervention (film)	Perceptions Perceptions and acceptability of the educational intervention will be explored in questionnaires and interviews	2 years
Secondary	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.	2 years