Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000878976
Ethics application status
Approved
Date submitted
25/08/2020
Date registered
3/09/2020
Date last updated
4/03/2022
Date data sharing statement initially provided
3/09/2020
Date results information initially provided
15/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Collaborative Maternity and Newborn Dashboard for the COVID-19 Pandemic
Scientific title
A Collaborative Maternity and Newborn Dashboard (CoMaND) for the COVID-19 pandemic: real-time monitoring of perinatal services performance indicators and health outcomes in Victoria
Secondary ID [1] 302142 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CoMaND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 318774 0
Perinatal outcomes 318775 0
COVID-19 pandemic 318776 0
Health services response 318777 0
Condition category
Condition code
Reproductive Health and Childbirth 316787 316787 0 0
Antenatal care
Reproductive Health and Childbirth 316788 316788 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 316789 316789 0 0
Complications of newborn
Reproductive Health and Childbirth 316790 316790 0 0
Fetal medicine and complications of pregnancy
Public Health 316791 316791 0 0
Epidemiology
Public Health 316792 316792 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an ecological time series analysis of maternal and perinatal outcomes covering the pre-pandemic period 2018-2019, the current pandemic period in 2020, and continuing through to end of 2022. There is no active participation or study intervention involved.
We will obtain routinely-collected outcomes from existing health service maternity databases for all births from 20 weeks gestation, including antenatal data from the time of first antenatal visit, intrapartum data , newborn data, and postnatal data for up to six weeks postpartum.
Intervention code [1] 318438 0
Not applicable
Comparator / control treatment
As this is a time series analysis, the maternity outcomes from pre-pandemic period (Jan 2018 - Dec 2019) will be used as the comparator for the pandemic period of 2020 onwards. The data sources will be the health service maternity databases used for routine data collection.
Control group
Historical

Outcomes
Primary outcome [1] 324904 0
Perinatal mortality ratio for babies born at 32 weeks or more as defined by Safer Care Victoria's Perinatal Services Performance Indicator 5 (PSPI 5)
(gestation standardised, excluding all terminations of pregnancy and deaths due to congenital anomalies)
All outcomes assessed from health service maternity databases.
Timepoint [1] 324904 0
Monthly and weekly trends from Jan 2018 to Dec 2022.
Primary outcome [2] 324905 0
Preterm births (total births 20-26 weeks) as assessed from health service maternity databases.
Subgroup analysis by gestation (20-27 weeks, 28-31 weeks, 23-36 weeks) and labour onset (spontaneous, induced, no labour)
Timepoint [2] 324905 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Primary outcome [3] 324906 0
Perinatal Services Performance Indicator (PSPI) 3: Severe fetal growth restriction (FGR) undelivered by 40 weeks gestation as assessed from health service maternity databases.
(Birth at 40 or more weeks gestation of a singleton baby with severe FGR as a percentage of singleton births (live and stillborn) with severe FGR born at and beyond 32 weeks’ gestation)
Timepoint [3] 324906 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [1] 386172 0
PSPI 1a: Rate of inductions in standard primiparae as assessed from health service maternity databases.
(a standard primiparae is defined as a woman 20-39 years of age, giving birth for the first time, free of obstetric complications, medical complications and pregnancy with a singleton pregnancy of gestation 37 weeks 0 days to 40 weeks 6 days, with an infant with birthweight above the 10th centile and vertex presentation)
Timepoint [1] 386172 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [2] 386329 0
PSPI 1b: Rate of caesarean section in standard primiparae as assessed from health service maternity databases.
Timepoint [2] 386329 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [3] 386330 0
PSPI 2: Rate of term babies without congenital anomalies who require additional care as assessed from health service maternity databases.
Timepoint [3] 386330 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [4] 386331 0
PSPI 4a: Rate of women who planned for vaginal birth following a primary caesarean section as assessed from health service maternity databases.
Timepoint [4] 386331 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [5] 386332 0
PSPI 4b: Rates of women who had a vaginal birth following a primary caesarean section as assessed from health service maternity databases.
Timepoint [5] 386332 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [6] 386333 0
PSPI 6a: Readmissions during the postnatal period (mother) as assessed from health service maternity databases.
Timepoint [6] 386333 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [7] 386334 0
PSPI 6b: Readmissions during the postnatal period (baby) as assessed from health service maternity databases.
Timepoint [7] 386334 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [8] 386335 0
PSPI 7: Smoking cessation rate as assessed from health service maternity databases.
Timepoint [8] 386335 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [9] 386336 0
PSPI 8c: Rate of final feed being taken exclusively and directly from the breast by breastfed babies born at 37+ weeks’ gestation as assessed from health service maternity databases.
Timepoint [9] 386336 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [10] 386337 0
PSPI 9: Rate of women attending their first antenatal visit prior to 12 weeks’ gestation as assessed from health service maternity databases.
Timepoint [10] 386337 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [11] 386338 0
PSPI 10: Term infants without birth anomalies with an Apgar score less than 7 at five minutes as assessed from health service maternity databases.
Timepoint [11] 386338 0
Monthly and weekly trends from Jan 2018 to Dec 2022
Secondary outcome [12] 386339 0
PSPI 12b: The rate of women vaccinated for influenza during pregnancy as assessed from health service maternity databases.
Timepoint [12] 386339 0
Monthly and weekly trends from Jan 2018 to Dec 2022

Eligibility
Key inclusion criteria
All births at one of the participating maternity hospitals between 1 January 2018 and 31 December 2022 that are recorded by the hospital maternity data collection system. The participating health services are:

• Mercy Health (Mercy Hospital for Women, Werribee Mercy Hospital)
• The Royal Women’s Hospital, The Women’s at Sandringham
• Monash Health (Monash Medical Centre, Casey Hospital, Dandenong Hospital)
• Northern Health (The Northern Hospital)
• Western Health (Joan Kirner Women’s and Children’s Hospital)
• Eastern Health (Box Hill Hospital and The Angliss Hospital)
• Peninsula Health (Frankston Hospital)
Minimum age
13 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Birth < 20 weeks gestation.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Time series analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/09/2020
Actual
4/07/2020
Date of last participant enrolment
Anticipated
Actual
31/12/2020
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
220000
Accrual to date
Final
220000
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306566 0
Charities/Societies/Foundations
Name [1] 306566 0
Norman Beischer Medical Research Foundation
Country [1] 306566 0
Australia
Funding source category [2] 306567 0
University
Name [2] 306567 0
University of Melbourne
Country [2] 306567 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 307091 0
None
Name [1] 307091 0
Address [1] 307091 0
Country [1] 307091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306751 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 306751 0
Office for Research, Austin Health
Level 8 HSB.
Austin Hospital
163 Studley Rd
Heidelberg VIC 3084
Ethics committee country [1] 306751 0
Australia
Date submitted for ethics approval [1] 306751 0
21/05/2020
Approval date [1] 306751 0
01/07/2020
Ethics approval number [1] 306751 0
HREC Reference Number: HREC/64722/Austin-2020
Ethics committee name [2] 306752 0
Mercy Health Human Research Ethics Committee
Ethics committee address [2] 306752 0
Mercy Hospital for Women
Mercy Health Human Research Ethics Committee
Level 6
163 Studley Rd
Heidelberg VIc 3084
Ethics committee country [2] 306752 0
Australia
Date submitted for ethics approval [2] 306752 0
25/05/2020
Approval date [2] 306752 0
10/07/2020
Ethics approval number [2] 306752 0
2020-031

Summary
Brief summary
The COVID-19 pandemic has resulted in a range of unprecedented changes to the way healthcare is delivered in all Australian public hospitals. In maternity hospitals across Victoria, these changes have resulted in an altered schedule of visits for antenatal care.

The aim of this study is to monitor monthly trends in key perinatal services performance indicators and maternal and newborn outcomes at the largest VIC maternity health services before, during and after the COVID19 pandemic.

This is a multi-centre retrospective cohort study that will gather routinely collected data on births from January 1 2018 to December 31 2022. The first half of the study period (from Jan 1 2018 to commencement of study following HREC and local governance approvals in mid-2020) will be retrospectively collected in order to provide baseline rates of all outcomes. Data will then be prospectively collected each calendar month from each of the participating sites, and this will be continuously updated to provide timely reports on maternity services.
These seven health services, including 12 hospitals, collectively look after 100% of all public births in metropolitan Melbourne.

The participating health services are:
• Mercy Health (Mercy Hospital for Women, Werribee Mercy Hospital)
• The Royal Women’s Hospital, The Women’s at Sandringham
• Monash Health (Monash Medical Centre, Casey Hospital, Dandenong Hospital)
• Northern Health (The Northern Hospital)
• Western Health (Joan Kirner Women’s and Children’s Hospital)
• Eastern Health (Box Hill Hospital and The Angliss Hospital)
• Peninsula Health (Frankston Hospital)

The approximate number of births captured during the study period is approximately 220,000. An estimated 44,000 women give birth in the participating hospitals each year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104902 0
A/Prof Lisa Hui
Address 104902 0
Mercy Hospital for Women
Department of Perinatal Medicine, Level 3
163 Studley Rd
Heidelberg VIC 3084
Country 104902 0
Australia
Phone 104902 0
+61 3 84584444
Fax 104902 0
Email 104902 0
lisa.hui@unimelb.edu.au
Contact person for public queries
Name 104903 0
A/Prof Lisa Hui
Address 104903 0
Mercy Hospital for Women
Department of Perinatal Medicine, Level 3
163 Studley Rd
Heidelberg VIC 3084
Country 104903 0
Australia
Phone 104903 0
+61 3 84584444
Fax 104903 0
Email 104903 0
lisa.hui@unimelb.edu.au
Contact person for scientific queries
Name 104904 0
A/Prof Lisa Hui
Address 104904 0
Mercy Hospital for Women
Department of Perinatal Medicine, Level 3
163 Studley Rd
Heidelberg VIC 3084
Country 104904 0
Australia
Phone 104904 0
+61 3 84584444
Fax 104904 0
Email 104904 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?
• Outcome data that underlie the results reported in the article (text, tables, figures and appendices)
• Study protocol
When will data be available (start and end dates)?
Beginning 12 months following analysis and article publication
No end date
Available to whom?
Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept The University of Melbourne’s conditions for access
Available for what types of analyses?
Unspecified
How or where can data be obtained?
Written request to principal investigator at
Department of Obstetrics and Gynaecology
University of Melbourne
Level 4 Mercy Hospital for Women
163 Studley Rd
Heidelberg VIC 3084
lisa.hui@unimelb.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hui L, Marzan MB, Potenza S, et alCollaborative ma... [More Details]
Study results articleYes Potenza S, Marzan MB, Rolnik DL, Palmer K, Said J,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCollaborative maternity and newborn dashboard (CoMaND) for the COVID-19 pandemic: A protocol for timely, adaptive monitoring of perinatal outcomes in Melbourne, Australia.2021https://dx.doi.org/10.1136/bmjopen-2021-055902
N.B. These documents automatically identified may not have been verified by the study sponsor.