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
ACTRN12620000449932
Ethics application status
Approved
Date submitted
4/04/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal and neonatal outcomes from women infected with SARS-COV2 (COVID-19) during pregnancy
Scientific title
Prospective registry of maternal, perinatal and neonatal outcomes from pregnancies infected with SARS-COV2 (COVID-19)
Secondary ID [1] 300948 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 316962 0
COVID-19 infection 316963 0
Condition category
Condition code
Reproductive Health and Childbirth 315117 315117 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 315118 315118 0 0
Complications of newborn
Reproductive Health and Childbirth 315119 315119 0 0
Fetal medicine and complications of pregnancy
Infection 315120 315120 0 0
Other infectious diseases
Respiratory 315134 315134 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
All women infected with SARS-CoV 2 (novel coronavirus) infection or who were diagnosed with COVID-19 during pregnancy. Observation will continue throughout pregnancy up until 6 weeks postpartum. In addition to standard care, women will be asked to complete a questionnaire after discharge to include postpartum and neonatal outcomes.
Intervention code [1] 317266 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323396 0
Maternal mortality from COVID-19
Timepoint [1] 323396 0
During pregnancy until 6 weeks postpartum
Primary outcome [2] 323397 0
Perinatal mortality (stillbirth, neonatal death)
Timepoint [2] 323397 0
During pregnancy and until day 28 in the neonate
Secondary outcome [1] 381786 0
Composite maternal morbidity from COVID-19 recorded from medical records. Including:
Hospitalisation for complications of COVID-19 (respiratory/pregnancy related)
ICU admission
Respiratory failure - need for NIV invasive ventilation
Renal failure - requiring dialysis
Coagulopathy inc DIC
Sepsis
Postpartum haemorrhage > 500 ml

Timepoint [1] 381786 0
Pregnancy until 6 weeks postpartum
Secondary outcome [2] 381787 0
Confirmed vertical transmission - SARs-COV2 PCR positive or positive serology result in any of:
Cord blood
Placenta
Amniotic fluid
Neonatal testing
Timepoint [2] 381787 0
Until day 28 of life
Secondary outcome [3] 381788 0
Mode of delivery - data collected as part of routine medical care
Timepoint [3] 381788 0
At birth
Secondary outcome [4] 381837 0
Composite neonatal morbidity:
NICU admission - medical record,
Respiratory distress - requiring > 12 hours NIV or intubation
Sepsis - requiring supportive care and treatment
Timepoint [4] 381837 0
Until day 28 or discharge from hospital
Secondary outcome [5] 381838 0
Congenital anomaly diagnosed in fetus or neonate: on imaging (ultrasound or MRI), genetic testing (karyotype, microarray), at post-mortem or by physical examination.
Timepoint [5] 381838 0
Diagnosed during pregnancy or in neonate

Eligibility
Key inclusion criteria
All pregnant women admitted to a participating hospital with COVID-19 during pregnancy
Minimum age
18 Years
Maximum age
60 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected COVID-19 not subsequently confirmed on PCR, serology or imaging

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be reported using frequencies and percentages or proportions for binary or categorical data. Percentages will be calculated based upon the number of patients for whom data are available. Continuous or dimensional variables will be summarised using means and standard deviations, with medians and interquartile ranges ( reported for potentially skewed data. Monthly incidence data and pregnancy outcome data will be calculated and reported to participating sites and national governance.
All analyses will be conducted using standard professional statistical software, such as Stata (Stata Corporation, College Station, Texas).

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,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 16373 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 16374 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 16375 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [4] 16377 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 16378 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 16379 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [7] 16380 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [8] 16381 0
Westmead Hospital - Westmead
Recruitment hospital [9] 16382 0
Royal Hospital for Women - Randwick
Recruitment hospital [10] 16383 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [11] 16384 0
John Hunter Hospital - New Lambton
Recruitment hospital [12] 16385 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [13] 16386 0
Mater Sydney - North Sydney
Recruitment hospital [14] 16387 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [15] 16388 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 29917 0
3052 - Parkville
Recruitment postcode(s) [2] 29918 0
3168 - Clayton
Recruitment postcode(s) [3] 29919 0
3084 - Heidelberg
Recruitment postcode(s) [4] 29921 0
7000 - Hobart
Recruitment postcode(s) [5] 29922 0
5042 - Bedford Park
Recruitment postcode(s) [6] 29923 0
5006 - North Adelaide
Recruitment postcode(s) [7] 29924 0
6008 - Subiaco
Recruitment postcode(s) [8] 29925 0
2145 - Westmead
Recruitment postcode(s) [9] 29926 0
2031 - Randwick
Recruitment postcode(s) [10] 29927 0
2050 - Camperdown
Recruitment postcode(s) [11] 29928 0
2305 - New Lambton
Recruitment postcode(s) [12] 29929 0
0810 - Tiwi
Recruitment postcode(s) [13] 29930 0
2060 - North Sydney
Recruitment postcode(s) [14] 29931 0
4575 - Birtinya
Recruitment postcode(s) [15] 29932 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 305389 0
University
Name [1] 305389 0
University of Melbourne
Address [1] 305389 0
Royal Women's Hospital
Flemington Road
Parkville
VIC 3052
Country [1] 305389 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Pregnancy Research Centre
Royal Women's Hospital
Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 305771 0
University
Name [1] 305771 0
Monash University
Address [1] 305771 0
Department of Obstetrics and Gynaecology
Monash Medical Centre
Clayton Road
Clayton
VIC 3168
Country [1] 305771 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305720 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 305720 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 305720 0
Australia
Date submitted for ethics approval [1] 305720 0
27/03/2020
Approval date [1] 305720 0
02/04/2020
Ethics approval number [1] 305720 0

Summary
Brief summary
This is a national study of women with confirmed COVID-19 in pregnancy in Australia. The study will collect information about all pregnant women who are confirmed to have SARS- CoV2 infection. The information will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff as we respond to the pandemic. Specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies.
Anonymous information will be collected by clinicians or clinical researchers who are based in maternity units in the Australia. Data collectors will have been sent a live link to a RedCap database to allow them to notify cases and complete an anonymous data collection form.
SARs-COV-2 is a new strain of coronavirus that has not previously been identified in humans. which causes a respiratory illness, but it is not known what impact it will have on pregnant women and their babies. In order to investigate risk factors, management and outcomes, the researchers plan to extend data collection to include data on all pregnant women with SARS-CoV-2.
The aim of this study is to learn more about the effects of SARS-COV-2 and its treatment on pregnant women and their babies. Pregnant women, are known to be at increased risk of developing more serious problems from respiratory viral infections, as was shown in the MERs, SARS and H1N1 'swine flu' epidemics. But little is currently known about this virus.
This study will collect and report contemporary data to inform ongoing pregnancy and neonatal management in order to optimise modifiable outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101346 0
Dr Clare Whitehead
Address 101346 0
Pregnancy research centre
University of Melbourne
Royal Women's Hospital
Flemington Road
Parkville
VIC 3052
Country 101346 0
Australia
Phone 101346 0
+61 3 8345 2000
Fax 101346 0
Email 101346 0
clarew@unimelb.edu.au
Contact person for public queries
Name 101347 0
Dr Miranda Davies-Tuck
Address 101347 0
Hudson Institute of Medical Research
27-31 Wright St
Clayton
VIC 3168
Country 101347 0
Australia
Phone 101347 0
+61 3 8572 2700
Fax 101347 0
Email 101347 0
miranda.davies@hudson.org.au
Contact person for scientific queries
Name 101348 0
Dr Clare Whitehead
Address 101348 0
Pregnancy research centre
University of Melbourne
Royal Women's Hospital
Flemington Road
Parkville
VIC 3052
Country 101348 0
Australia
Phone 101348 0
+61 3 8345 2000
Fax 101348 0
Email 101348 0
clarew@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 clinical outcome data collected
When will data be available (start and end dates)?
From commencement of study individual participant data (if pregnancy completed) will be publicly available. No end date determined.
Available to whom?
Collaborators with HREC approved relevant research proposals
Available for what types of analyses?
For the aims in approved proposals
How or where can data be obtained?
Subject to approval by the PIs. Please contact via email: clarew@unimelb.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results