Trial Review

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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
Sex
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
10/04/2020
Actual
Date of last participant enrolment
Anticipated
1/04/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
200
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
Country [1] 305389 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Country
Australia
Secondary sponsor category [1] 305771 0
University
Name [1] 305771 0
Monash University
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
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
Trial website
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
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
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 the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Collaborators with HREC approved relevant research proposals


Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified clinical outcome data collected

What types of analyses could be done with individual participant data?
• For the aims in approved proposals

When can requests for individual participant data be made (start and end dates)?
From:
From commencement of study individual participant data (if pregnancy completed) will be publicly available. No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Subject to approval by the PIs. Please contact via email: clarew@unimelb.edu.au

Are there extra considerations when requesting access to individual participant data?
No


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.