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Completed

NCT Number: NCT03511274

Reducing Acquisition of CMV Through Antenatal Education

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.

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Key information

Conditions

Cytomegalovirus Congenital Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St George's, University of London

London, SW17 0RE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Educational intervention development

    Time frame: 3 years

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

Secondary outcomes

  1. Proportion of women willing to be screened for CMV

    Time frame: 1 year

    Proportion of women approached who are willing to have antenatal booking blood tested for CMV antibodies to determine serostatus

  2. Proportion of women seronegative at antenatal booking

    Time frame: 1 year

    Proportion of women who have no evidence of previous CMV infection at the time of antenatal booking

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

    Time frame: 1 year

    Proportion of women who have evidence of primary CMV infection within the first trimester of pregnancy

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

    Time frame: 1 year

    Proportion of seronegative pregnant women willing to participate in feasibility study, which includes randomisation to the educational intervention or treatment as usual

  5. Seroconversion rate

    Time frame: 18 months

    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.

  6. Proportion of infants with congenital CMV

    Time frame: 2 years

    The proportion of infants with a positive test for CMV in the first 21 days of life

  7. Measures of adherence

    Time frame: 2 years

    Women in the treatment arm will be asked to a questionnaire to assess their perceptions of adherence to the advice given

  8. Change in knowledge

    Time frame: 2 years

    Women will complete questionnaires before and after the intervention to assess changes in knowledge about CMV

  9. Knowledge of CMV risk reduction measures

    Time frame: 2 years

    Women will complete questionnaires before and after the intervention to assess changes in knowledge about risk reduction measures and self-efficacy towards these

  10. Acceptability of prevention measures

    Time frame: 2 years

    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.

  11. Acceptability of the educational intervention (film)

    Time frame: 2 years

    Perceptions Perceptions and acceptability of the educational intervention will be explored in questionnaires and interviews

  12. Anxiety level

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • CMV Action
  • Kingston University
  • University College, London
  • University of Cambridge

Registry information

Official study title

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

Acronym: RACEFIT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2018
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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