An Observational, Longitudinal, Natural History, Feasibility Cohort Study to Evaluate the Characteristics of Cytomegalovirus (CMV) Shedding in CMV Seropositive Women Throughout Pregnancy (cCHIPS)
This study is now in the analysis phase
Cytomegalovirus (better known as CMV) is a common virus and in healthy adults, it can cause mild illness. However, if a woman catches CMV for the first time when she is pregnant or if the CMV virus reactivates or she is infected with another strain of the virus, 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, such as problems with hearing or development. Our study is exploring the characteristics of CMV shedding in saliva, urine and vaginal secretions during pregnancy in women who have previously been infected with CMV (known as being ‘seropositive’) in order to understand better the effects it has in pregnancy and identify ways to help prevent CMV infection in babies in the future.
Inclusion and exclusion criteria
Inclusion criteria
- Pregnant
- CMV seropositive
- Willing and able to provide informed consent
- Living with child(ren), at least one of whom is less than four years old
- Willing to have saliva, urine and vaginal secretion sampling
- Willing to be followed up until postpartum period
Exclusion criteria
- Age less than 18 years
- Evidence of acute maternal CMV infection at the time of screening
- Documented immunodeficiency of any aetiology including the use of oral steroid therapy equivalent to >1mg/kg of prednisone per day for more than one week
- In the opinion of the investigator is unlikely to comply with the study procedures
- In the opinion of the investigator does not have adequate understanding or verbal and written English
What participating in the study involves?
The study involves four study visits: early in pregnancy, middle of pregnancy, late in pregnancy and after birth. As much as possible these visits will be coincided with participants routine antenatal appointments. At each visit, participants will complete a short questionnaire and be asked to take their own samples of urine, saliva and vaginal secretions to check how much CMV (if any) is excreted in these samples. We will provide simple instructions on how to do this. If participants agree to it, a blood sample will also be collected at each visit to look at their immune response as much as possible this will be performed at the same time as their other routine antenatal blood tests. All newborn babies of women participating in the study will be offered testing to see if they have congenital CMV infection. In the unlikely event that the baby has congenital CMV infection, we will be able to refer them in a timely manner to an appropriate children’s doctor with expertise in infection, to ensure that he or she receives the appropriate management as soon as possible. Currently, babies are not routinely screened after birth for CMV infection in the NHS and they would only be tested if any problems were picked up later on.
Results (if applicable) – Results will be published here: