ANZCTR - Registration

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

COVID-19 infection

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

Complications of newborn

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Maternal mortality from COVID-19

Timepoint [1]

During pregnancy until 6 weeks postpartum

Primary outcome [2]

Perinatal mortality (stillbirth, neonatal death)

Timepoint [2]

During pregnancy and until day 28 in the neonate

Secondary outcome [1]

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]

Pregnancy until 6 weeks postpartum

Secondary outcome [2]

Confirmed vertical transmission - SARs-COV2 PCR positive or positive serology result in any of: Cord blood Placenta Amniotic fluid Neonatal testing

Timepoint [2]

Until day 28 of life

Secondary outcome [3]

Mode of delivery - data collected as part of routine medical care

Timepoint [3]

At birth

Secondary outcome [4]

Composite neonatal morbidity: NICU admission - medical record, Respiratory distress - requiring > 12 hours NIV or intubation Sepsis - requiring supportive care and treatment

Timepoint [4]

Until day 28 or discharge from hospital

Secondary outcome [5]

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]

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?

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]

The Royal Women's Hospital - Parkville

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

Mercy Hospital for Women - Heidelberg

Recruitment hospital [4]

Royal Hobart Hospital - Hobart

Recruitment hospital [5]

Flinders Medical Centre - Bedford Park

Recruitment hospital [6]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [7]

King Edward Memorial Hospital - Subiaco

Recruitment hospital [8]

Westmead Hospital - Westmead

Recruitment hospital [9]

Royal Hospital for Women - Randwick

Recruitment hospital [10]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [11]

John Hunter Hospital - New Lambton

Recruitment hospital [12]

Royal Darwin Hospital - Tiwi

Recruitment hospital [13]

Mater Sydney - North Sydney

Recruitment hospital [14]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [15]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

7000 - Hobart

Recruitment postcode(s) [5]

5042 - Bedford Park

Recruitment postcode(s) [6]

5006 - North Adelaide

Recruitment postcode(s) [7]

6008 - Subiaco

Recruitment postcode(s) [8]

2145 - Westmead

Recruitment postcode(s) [9]

2031 - Randwick

Recruitment postcode(s) [10]

2050 - Camperdown

Recruitment postcode(s) [11]

2305 - New Lambton

Recruitment postcode(s) [12]

0810 - Tiwi

Recruitment postcode(s) [13]

2060 - North Sydney

Recruitment postcode(s) [14]

4575 - Birtinya

Recruitment postcode(s) [15]

4029 - Herston

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Melbourne

Address [1]

Royal Women's Hospital Flemington Road Parkville VIC 3052

Country [1]

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]

University

Name [1]

Monash University

Address [1]

Department of Obstetrics and Gynaecology Monash Medical Centre Clayton Road Clayton VIC 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

Monash Health
246 Clayton Road
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/03/2020

Approval date [1]

02/04/2020

Ethics approval number [1]

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

Dr Clare Whitehead

Address

Pregnancy research centre University of Melbourne Royal Women's Hospital Flemington Road Parkville VIC 3052

Country

Australia

Phone

+61 3 8345 2000

Fax

[email protected]

Contact person for public queries

Name

Miranda Davies-Tuck

Address

Hudson Institute of Medical Research 27-31 Wright St Clayton VIC 3168

Country

Australia

Phone

+61 3 8572 2700

Fax

[email protected]

Contact person for scientific queries

Name

Clare Whitehead

Address

Pregnancy research centre University of Melbourne Royal Women's Hospital Flemington Road Parkville VIC 3052

Country

Australia

Phone

+61 3 8345 2000

Fax

[email protected]

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: [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically