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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000593932p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2020
Date registered
22/05/2020
Date last updated
22/05/2020
Date data sharing statement initially provided
22/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Has the threat of SARS COVID-19 increased influenza vaccination rates in pregnant women?
Scientific title
Has the threat of SARS COVID-19 increased influenza vaccination rates in pregnant women?
Secondary ID [1] 301276 0
Nil known
Universal Trial Number (UTN)
U1111-1252-4148
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza vaccination 317454 0
pregnancy 317545 0
Condition category
Condition code
Infection 315553 315553 0 0
Other infectious diseases
Reproductive Health and Childbirth 315636 315636 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Effect of covid pandemic on rates of infleunza vaccination in pregnant women. Outcome group are pregnant women delivering after the announcement by WHO of the global pandemic. Part A is an audit of vaccination rates. Part B is a survey study, participants answer a 5minute questionnaire addressing factors why they did or did not receive vaccination. Single observation at delivery.
Intervention code [1] 317585 0
Not applicable
Comparator / control treatment
Control group are pregnant women delivering at the Canberra Hospital between 1/7/2017 t0 31/7/2017
Post COVID-19 group are pregnant women delivering at the Canberra Hospital in a one month period selected imediately after ethics approval granted (probably 1/8/20 to 31/8/20)
Control group
Historical

Outcomes
Primary outcome [1] 323798 0
Rate of influenza vaccination in women giving birth at greater than 20 weeks gestation
Data extracted from medical record system and validated with batch number of actual vaccination
Timepoint [1] 323798 0
Birth of baby
Secondary outcome [1] 382923 0
Rate of pertussis vaccination in women giving birth at greater than 20 weeks gestation
Data extracted from medical record system and validated with batch number of actual vaccination
Timepoint [1] 382923 0
Birth
Secondary outcome [2] 383159 0
Thematic analysis of reasons for having or declining vaccination
Data extracted from questionnaire delivered at birth
Timepoint [2] 383159 0
Birth

Eligibility
Key inclusion criteria
Pregnant women who deliver a baby at greater than 20 weeks gestation
Minimum age
16 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <16 years
Miscarriage <20 weeks pregnancy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Discrete data will be analysed using number and per cent for discrete data, and mean and SD for normative continuous data. Data will be compared using chi square test for discrete data and Student’s t-test for continuous data. In multivariate analysis, all variables significant at p<0.1 will be included in the model. Thematic analysis will occur using standardised methodology

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 16663 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 30259 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 305723 0
Self funded/Unfunded
Name [1] 305723 0
Professor Julie Quinlivan
Address [1] 305723 0
ANU Medical School
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Australia
Country [1] 305723 0
Australia
Primary sponsor type
Individual
Name
Professor Julie Quinlivan
Address
ANU Medical School
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Australia
Country
Australia
Secondary sponsor category [1] 306143 0
None
Name [1] 306143 0
Address [1] 306143 0
Country [1] 306143 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305998 0
ACT Health
Ethics committee address [1] 305998 0
The Canberra Hospital
Hospital Rd, Garran ACT 2605
Australia
Ethics committee country [1] 305998 0
Australia
Date submitted for ethics approval [1] 305998 0
28/05/2020
Approval date [1] 305998 0
Ethics approval number [1] 305998 0

Summary
Brief summary
Seasonal influenza infection is a significant cause of morbidity and mortality which can be prevented by vaccination. Notably, pregnant women and babies under 6 months are at significant risk of hospitalisation and adverse health outcomes if infected with influenza. In a retrospective audit, seasonal influenza vaccination rates in pregnant women at the Centenary Hospital for Women and Children at the Canberra Hospital were found to have increased from 35% in 2017 to 79.8% in 2017 with the introduction of a mandatory field in an electronic health record. This study aims to investigate compliance of pregnant women with seasonal influenza vaccination rates at the Centenary Hospital for Women and Children during the Covid-19 pandemic using a follow-up audit.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Nil

Contacts
Principal investigator
Name 102362 0
Prof Julie Quinlivan
Address 102362 0
ANU Medical School
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Australia
Country 102362 0
Australia
Phone 102362 0
+61 2 61209100
Fax 102362 0
Email 102362 0
julie.quinlivan@nd.edu.au
Contact person for public queries
Name 102363 0
Prof Julie Quinlivan
Address 102363 0
ANU Medical School
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Australia
Country 102363 0
Australia
Phone 102363 0
+61 2 61209100
Fax 102363 0
Email 102363 0
julie.quinlivan@nd.edu.au
Contact person for scientific queries
Name 102364 0
Prof Julie Quinlivan
Address 102364 0
ANU Medical School
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Australia
Country 102364 0
Australia
Phone 102364 0
+61 2 61209100
Fax 102364 0
Email 102364 0
julie.quinlivan@nd.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?
Vaccination rates at baseline and follow up
When will data be available (start and end dates)?
January 2023 when trial complete and submitted for publication until January 2025
Available to whom?
Researchers must apply to the trial co-ordinator and state their reason for requesting access to trial data. Their request will be considered on a case by case basis by the investigating team. Decisions to share data will depend upon the relevance of the request to the pirmary aim of the study for which data was originally collected.
Available for what types of analyses?
Systematic reviews
How or where can data be obtained?
Writing to the principle investigator
professor Julie Quinlivan
c/o ANU Medical School
Building 4, The Canberra Hospital, Hospital Rd, Garran ACT 2605
Australia
What supporting documents are/will be available?
No other documents available
Summary results
No Results