Antenatal CMV Evaluation of Screening (ACES) Study
Research type
Research Study
Full title
Antenatal CMV Evaluation of Screening (ACES) Study
IRAS ID
338854
Contact name
Eleni Nastouli
Contact email
Sponsor organisation
University College London Hospital Trust
Clinicaltrials.gov Identifier
Z6364106/2024/04/120, UCL Data protection Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
CMV is one of the most common congenital infections, with around 1 in 200 infants born in the UK estimated to be infected. For most babies with congenital CMV this does not cause any problems, but for around 1 in 5 it causes long term health problems such as hearing loss.
Pregnant women are not routinely offered CMV testing in the UK currently. One reason for this has been the lack of available interventions to prevent a CMV infection being passed from mother to unborn baby, and development of CMV-related problems in the baby. Recently, studies have shown that antiviral medication can reduce the risk of transmission of CMV from mother to unborn baby if the mother has a first-time (‘primary’) infection in early pregnancy and this has raised new questions around CMV screening, and whether this should be offered routinely in pregnancy. These include questions around the epidemiology of CMV among women seeking antenatal care in the UK, feasibility of incorporating CMV screening into existing antenatal NHS pathways, and the views of pregnant women on the screening process and subsequent options after receiving results.
We will explore how common previous CMV infection is among women receiving antenatal care at UCLH. We will conduct a prospective study in which CMV screening is offered to around 1,000 women booking for antenatal care at UCLH, and investigate feasibility, acceptability (including surveys/interviews of women and healthcare professionals) and gain preliminary data on cost. Women identified as having a recent primary CMV infection through screening will follow standard of care with respect to further testing, monitoring and offer of treatment where appropriate. Sub-studies will explore emerging predictive markers in amniotic fluid and novel diagnostics for CMV, and current policy and practice around antenatal CMV screening and use of antivirals in the UK and other European countries.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
25/YH/0157
Date of REC Opinion
4 Aug 2025
REC opinion
Favourable Opinion