None listed
Conditions
Brief summary
Congenital cytomegalovirus (CMV) infection can lead to lifelong disabilities in babies if passed from the mother during pregnancy. It is the leading infectious cause of newborn disability in Australia and can result in conditions such as deafness, intellectual disability, and cerebral palsy. To prevent the morbidity and mortality associated with CMV, it is important for pregnant women to receive appropriate antenatal care and support. This study aims to assess the feasibility and acceptability of routine serological screening for maternal primary CMV infection early in pregnancy. Pregnant women who test negative for CMV IgG before 10 weeks of gestation will be eligible to participate. Participation involves providing a blood sample between 10 weeks 0 days and 13 weeks and 6 days of gestation for repeated testing of CMV infection. Additionally, participants will complete three questionnaires during the study period to evaluate the effectiveness of the CMV screening protocol, including measures of anxiety, decisional conflict, and decisional regret. If the serology results are negative (indicating no infection) at 10-14 weeks of gestation, the woman will be informed over the phone, and the results will be recorded in her medical records. If a woman is found to have been infected by CMV or potentially infected, the results will be disclosed by a maternal fetal medicine specialist, and she will be referred to the Perinatal infectious diseases clinic for counseling and clinical management. The management options offered to these women follow the standard clinical care guidelines for perinatal ID clinics. In case of a confirmed infection during pregnancy (expected in up to 5% of participants), the woman will be offered management options according to usual clinical care. These options may include informing the woman about the possibility of using valaciclovir, prenatal diagnosis through amniocentesis, and, if necessary, fetal MRI. The woman's decision to participate or not in the research will not impact the clinical care provided for CMV infection. At the end of the study, we aim to report the rate of CMV testing uptake during 10-14 weeks of gestation among pregnant women who initially tested negative for CMV IgG at their first antenatal visit with their GP or obstetrician. By analyzing feedback from participants regarding their experience with CMV screening and the clinical management they received for the prevention of congenital CMV infection, we will evaluate the feasibility of implementing a CMV screening program. Furthermore, the study seeks to determine the prevalence of primary CMV infection in the first trimester of pregnancy, document the clinical pathways chosen by participants who were diagnosed with primary CMV infection during this period, and report any psychological consequences associated with antenatal serological screening for CMV infection.
Interventions
Antenatal CMV screening - Participants will have serological screening for first trimester primary CMV infection by testing for CMV-specific IgG and IgM on a blood sample collected between 10 weeks and 0 days and 13 weeks and 6 days of gestation. The pathology request form for a blood test will be sent to the participant via email or post (at their preference). A maternal peripheral venous blood sample will be collected at any of the pathology collecting sites used by Austin Health in Melbourne,
Antenatal CMV screening - Participants will have serological screening for first trimester primary CMV infection by testing for CMV-specific IgG and IgM on a blood sample collected between 10 weeks and 0 days and 13 weeks and 6 days of gestation. The pathology request form for a blood test will be sent to the participant via email or post (at their preference). A maternal peripheral venous blood sample will be collected at any of the pathology collecting sites used by Austin Health in Melbourne, Victoria. Austin Pathology will perform the CMV serology testing, and approximately 1-2 teaspoons (6ml) of blood will be required for CMV testing. We will keep a record of each study participant's involvement in the CMV blood test, and their CMV serology results will be closely monitored by conducting audits of the patients' clinical folders at Mercy Health. If the results of the serology are negative at 10 weeks and 0 days -13 weeks and 6 days of gestation (indicating no infection), these results will be disclosed by the research midwife to the participant by telephone and recorded in the medical record. If the woman is found to have been infected by CMV (seroconverted from CMV IgG negative to IgG positive), or potentially infected (CMV IgG negative, CMV IgM positive) the results will be disclosed over the phone by a doctor specializing in maternal fetal medicine and the woman will be referred to the Perinatal infectious diseases clinic at Mercy Hospital located in Heidelberg, Victoria for counselling and clinical management. All management options offered to those women are current standards for clinical care in our perinatal ID clinic. i.e. the intervention being assessed in this study is the uptake of the serological test at 10-14 weeks gestation, not the downstream management protocol for maternal primary infection. If a study participant has a confirmed infection in pregnancy (expected to be up to 5% of participants), they will be offered management according to usual clinical care, which includes informing the woman about the option of valaciclovir therapy, options for prenatal diagnosis with amniocentesis, +/- fetal MRI. The woman’s decision to participate or not participate in the research will not influence the clinical care offered in case of CMV infection.
Sponsors
University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for participation in this study are as follows: individuals must be 18 years of age or older, have tested negative for CMV IgG on their antenatal booking bloods performed before 9 weeks and 6 days of gestation, and be no more than 14 weeks and 0 days pregnant at the time of recruitment. Additionally, participants must have the capacity to provide informed consent for medical procedures and either be fluent in English or have access to a qualified interpreter who can explain the study protocol and assist in obtaining informed consent. Furthermore, individuals must have a planned birth at the Mercy Hospital for Women in Victoria, Australia.
Exclusion criteria
The exclusion criteria for participation in this study are as follows: individuals who are younger than 18 years of age are not eligible to participate. Participants who are unable to provide informed consent for medical procedures will be excluded. Individuals who are at or beyond 14 weeks and 0 days of gestation at the time of recruitment are not eligible for inclusion. Lastly, individuals who have a known fetal anomaly in the current pregnancy are not eligible to participate.
Outcome results
None listed