Cytomegalovirus Infections Clinical Trial
Official title:
Development of Potential Biomarkers for Foetal Brain Development After Congenital CMV Infection
Cytomegalovirus (CMV) is the most common cause of congenital infection, with approximately
0.5% of pregnant women being infected during pregnancy. CMV transmission to the fetus occurs
in about one third of women who are infected in first trimester. Babies infected before
birth are at risk for serious neurological complications such as intellectual disability,
seizures, deafness, and even death. Most couples facing a diagnosis of congenital
cytomegalovirus infection in their unborn baby focus heavily on the predicted neurological
outcome for their child. To date, methods to assess brain development in fetuses have been
mainly limited to detecting structural brain abnormalities by ultrasound. However, these
ultrasound signs may not become apparent until very late in pregnancy, and some neurological
disability is not accompanied by any structural brain changes. More research on methods of
predicting neurodevelopmental outcome independent of structural brain malformations before
third trimester is urgently needed.
The purpose of this study is to investigate a new method of studying the health of unborn
babies using amniotic fluid. Amniocentesis is often performed after maternal CMV infection
to diagnose fetal infection. Prior research by Dr Hui has demonstrated that cell free RNA in
amniotic fluid can provide meaningful information from multiple organs including the fetal
brain. The investigators propose to collect and analyse a small sample of amniotic fluid to
detect which genes are turned "on" or "off" (gene expression) in a fetus that has a
congenital CMV infection, compared to those without any infection.
The genes that are differentially expressed in CMV infected fetuses will then be analysed to
provide information on the broad physiological processes that are altered due to the
infection ("functional analysis") and identify neurodevelopmental gene transcripts of
interest for future studies ("biomarker discovery").
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - women with evidence of maternal primary CMV infection during pregnancy - Fetuses with structural abnormalities suggestive of congenital CMV infection - all patients consent to amniocentesis - age 18 years or over and capable of giving informed consent Exclusion Criteria: - Women who do not give consent - not capable of consent for medical procedures - language barrier - under 18 years of age. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | University of Melbourne |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | gene expression in amniotic fluid after CMV seroconversion | That fetuses infected with CMV will have an altered gene expression profile compared with noninfected fetuses, as ascertained in amniotic fluid cell-free RNA | 30 months |
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