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Trial registered on ANZCTR


Registration number
ACTRN12623000710628
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
4/07/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
4/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Antenatal cytomegalovirus (CMV) screening pilot study
Scientific title
Antenatal screening for first trimester cytomegalovirus (CMV) infection: a pilot study
Secondary ID [1] 309734 0
Nil known
Universal Trial Number (UTN)
U1111-1292-9712
Trial acronym
Linked study record
Rudd, I.P., Marzan, M.B. and Hui, L. (2023), Cytomegalovirus serological screening at the first antenatal visit: A tertiary-centre audit of general practitioner practices and maternal seroprevalence. Aust N Z J Obstet Gynaecol, 63: 454-459. https://doi.org/10.1111/ajo.13645

Health condition
Health condition(s) or problem(s) studied:
Maternal primary infection with cytomegalovirus 330128 0
Condition category
Condition code
Reproductive Health and Childbirth 327010 327010 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326175 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334870 0
Review participant's medical records to evaluate the rate of uptake of CMV serological testing at `10-14 weeks of gestation among pregnant women who were CMV IgG negative at their first antenatal visit.
Timepoint [1] 334870 0
At the conclusion of study
Secondary outcome [1] 422291 0
Participants overall rating of their experience of CMV screening collected using study specific questionnaires (5 point Likert scale).
Timepoint [1] 422291 0
at recruitment, between 15 weeks 0 days and 19 weeks 6 days of gestation and within 6 weeks postpartum.
Secondary outcome [2] 422292 0
Rate of CMV seroconversion in first trimester assessed by repeating CMV serology between 10-14 weeks of gestation.
Timepoint [2] 422292 0
At the conclusion of the study
Secondary outcome [3] 422293 0
Audit of patient medical records to determine the uptake rate of valaciclovir therapy among participants who had a documented CMV infection.
Timepoint [3] 422293 0
At the conclusion of study
Secondary outcome [4] 422296 0
Change in participant's anxiety levels before and after CMV screening assessed using State-Trait Anxiety Inventory.
Timepoint [4] 422296 0
at recruitment, between 15 weeks 0 days and 19 weeks 6 days of gestation and within 6 weeks postpartum.
Secondary outcome [5] 422693 0
Participants preferences for clinical management collected using medical records.
Timepoint [5] 422693 0
At conclusion of the study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
1) Sample Size Estimation - We plan to recruit for a period of 24 months, with an expected 600 eligible women based on our published audit (25 per month, 300 per year). We estimate a 60% enrolment rate, considering logistic delays in contacting people before 14 weeks gestation, and potential difficulties with sourcing interpreters, and patient choice. Therefore, we estimate that 360 women will be enrolled over the 2-year period.

2) Power Calculations - Our primary outcome measure is the recruitment rate among those eligible women who are successfully contacted before 14 weeks gestation. We estimate that 80% will be willing to have a serological test performed. We will only require a sample size of 246 to provide an 80% acceptability rate with precision of 0.05, with 95% confidence level.. However, the survey data, which aims to assess the patient experience, will have the primary outcome of the Likert scale. We aim to determine if at least 70% of women were satisfied or very satisfied with the screening protocol (scoring 4 or 5). This requires a population of 323 respondents. The sample size of 360 will allow for a 10% rate of incomplete questionnaires and missing data.

3)Statistical Methods To Be Undertaken - The results of this study will be summarized using descriptive statistics. We will describe the demographic features of those that did and did not consent to participate to measure ascertainment bias. We will report the uptake rate of screening, the seroconversion rates, and the uptake rates of current clinical management options such as valaciclovir and amniocentesis.

We will present all data in aggregated form so that no individual can be identified from the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2023
Actual
9/11/2023
Date of last participant enrolment
Anticipated
3/07/2025
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
360
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24795 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 40438 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313923 0
Charities/Societies/Foundations
Name [1] 313923 0
Norman Beischer Medical Research Foundation
Country [1] 313923 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 316123 0
None
Name [1] 316123 0
Address [1] 316123 0
Country [1] 316123 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313069 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 313069 0
Administration Officer, Human Research Ethics Committee
c/- Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
Ethics committee country [1] 313069 0
Australia
Date submitted for ethics approval [1] 313069 0
22/05/2023
Approval date [1] 313069 0
18/07/2023
Ethics approval number [1] 313069 0
2023-019

Summary
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.
Trial website
https://mercyperinatal.com/project/ese-cmv-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126882 0
A/Prof Lisa Hui
Address 126882 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC - 3084
Country 126882 0
Australia
Phone 126882 0
+61 3 8458 4368
Fax 126882 0
Email 126882 0
lisa.hui@unimelb.edu.au
Contact person for public queries
Name 126883 0
A/Prof Lisa Hui
Address 126883 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC - 3084
Country 126883 0
Australia
Phone 126883 0
+61 3 8458 4368
Fax 126883 0
Email 126883 0
lisa.hui@unimelb.edu.au
Contact person for scientific queries
Name 126884 0
A/Prof Lisa Hui
Address 126884 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC - 3084
Country 126884 0
Australia
Phone 126884 0
+61 3 8458 4368
Fax 126884 0
Email 126884 0
lisa.hui@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient level data may be shared to researchers from a research institution for ethically approved projects following ethics approval from our local HREC.
When will data be available (start and end dates)?
Available for 5 years after publication.
Available to whom?
Researchers from established research institutions with ethics approval for data collection.
Available for what types of analyses?
Meta analyses, systematic reviews
How or where can data be obtained?
Application to Mercy HREC at ethics@mercy.com.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.