RACE FIT (Phase 2)

  • Research type

    Research Study

  • Full title

    Reducing Acquisition of CMV through antenatal Education: A feasibility study to assess an educational intervention to prevent cytomegalovirus infection in pregnancy

  • IRAS ID

    239977

  • Contact name

    Christine Jones

  • Contact email

    C.E.Jones@soton.ac.uk

  • Clinicaltrials.gov Identifier

    NCT03511274

  • Duration of Study in the UK

    1 years, 6 months, 16 days

  • Research summary

    Cytomegalovirus (CMV) is a common virus. In healthy adults, CMV causes mild illness and most people don’t know if they have had CMV before. However, if a woman catches CMV when she is pregnant, there is a chance that the infection can be passed on to her baby. In a small number of cases, this can cause problems in the baby, for example hearing or developmental problems. There is currently no vaccine against CMV and finding ways of protecting women in pregnancy is a priority, particularly for those women who live with young children and those who have never been infected before as they are at greatest risk of becoming infected and passing the infection to their foetus.

    The risk of acquiring CMV is greater for women who live with young children because these children are frequently infected with the virus, they shed more virus in their bodily fluids than older children and adults and their care needs require more contact with their bodily fluids (for example changing nappies, feeding etc.)
    Although having had previous infection does not entirely protect women from reinfection or reactivation of a previous infection, the chance of passing CMV infection to the baby is lower if a woman has had CMV infection before and therefore having had previous infection is in some way protective.

    In this study we will explore the feasiblity of conducting a randomised controlled trial of an educational film about CMV in pregnancy and we will concentrate on those women who are seronegative and live with children aged less than three years.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    18/SC/0360

  • Date of REC Opinion

    6 Aug 2018

  • REC opinion

    Further Information Favourable Opinion