ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001777189

Ethics application status

Approved

Date submitted

25/11/2019

Date registered

16/12/2019

Date last updated

28/01/2024

Date data sharing statement initially provided

16/12/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Safer Baby Bundle Study: Assessing the impact of a stillbirth prevention bundle of care for improving best practice care for women during pregnancy in Australia

Scientific title

Safer Baby Bundle Study: Assessing the impact of a stillbirth prevention bundle of care for improving best practice care for women during pregnancy in Australia

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1240-5981

Trial acronym

SBB

Linked study record

Health condition

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

Stillbirth

Fetal death

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Safer Baby Bundle (SBB): a bundle of care to address the priority evidence practice gaps in stillbirth prevention. This is a before and after study evaluating the impact of a healthcare improvement initiative across maternity services in three states; Queensland, Victoria and New South Wales. The impact of the SBB on stillbirth rates at 28 weeks’ gestation or more and other important maternal and newborn outcomes will be investigated.

The SBB addresses areas associated with substandard care and stillbirth. The SBB is a structured package of change ideas and interventions (containing five evidence-based elements) and is designed to formalise care and reduce practice variation. The SBB contains five elements:
Element 1: Supporting women to stop smoking in pregnancy
Element 2: Improving detection and management of fetal growth restriction
Element 3: Raising awareness and improving care for women with decreased fetal movements
Element 4: Improving awareness of maternal safe going-to-sleep position in late pregnancy
Element 5: Improving decision-making about the timing of birth for women with risk factors for stillbirth

The five included elements are the same for women and their care providers, providing complimentary messaging and resources. For health care providers this includes an educational package (both eLearning and face-to-face training); best practice recommendations; clinical audit tools; evidence summaries with clinical care pathways. The educational program and resources for clinicians have been specifically developed for this project. Women and their families will be provided with written information including brochures (designed specifically for this study), supplemented by a public awareness program and a mobile phone app.

Implementation of the SBB will be undertaken in partnership with each states health department. State healthcare quality and safety improvement agencies are responsible for recruitment of participating hospitals and implementation. Participation in the study is open to all eligible maternity hospitals across the three jurisdictions, with all those who voluntarily express an interest recruited. This study is a mixed methods, multi-centre, ‘before and after’ evaluation of the implementation of the SBB in three health jurisdictions. The study design is pragmatic to account for differences across jurisdictions for the level of implementation support provided and commencement dates. To allow for differences in commencement dates between jurisdictions and disruptions, the study implementation period (which includes pre and post implementation data collection as part of the implementation strategy) will run for 2.5 years, followed by a 2 year post-implementation phase.

Participating jurisdictions- Each state has an implementation team to provide leadership, generate and sustain motivation for change and provide tools to support practice change through education, audit and feedback, bench-marking and implementation support forums. A mixed-methods approach will be used to assess the processes, impacts and outcomes of the SBB initiative. Change in rates for the primary clinical outcome, stillbirth rate at 28 or more weeks, will compare the implementation rate (including longer term trends over 15 years) with the rate in the 2 year post-implementation period using routinely collected perinatal data. Approval will be sought through the relevant state perinatal data collection custodians to access and analyse routinely collected population-based surveillance system data covering all births in NSW, VIC and QLD public and private hospitals over the study time period (15 years’ pre-implementation to 2 years’ post-implementation). The relevant duration for participant data collection is for the period from the first antenatal visit (booking appointment) through to six weeks post-birth.

Participating hospitals are required to embed the SBB within their existing processes. Prevention champions at each site will provide leadership, collect baseline data, attend implementation learning support forums and drive implementation of best practice recommendations in the local context. All maternity staff at participating hospitals will be encouraged and supported to complete the 2 hour eLearning program (specifically designed for this project) covering each element of the bundle and to attend the complimentary one-day face-to-face workshop to improve practical skills and enhance learnings.

Surveys of women, healthcare professionals and maternity service leads will be administered electronically pre and post implementation. The survey will be administered to women (with a singleton pregnancy without lethal fetal abnormalities) at participating hospitals following the birth (before hospital discharge) across a sample of 30 hospitals (10 hospitals per state) stratified by service capability level and geographic location (metropolitan, regional and remote). Midwives and doctors providing maternity care at the participating hospitals will also be invited to undertake pre and post-implementation questionnaires.

Intervention code [1]

Prevention

Comparator / control treatment

Historical comparator- standard care, 15-years pre-implementation (from January 2004 to implementation commencement date (which will vary by State)) using State level (NSW, QLD, VIC) routinely collected perinatal data-sets.

Control group

Historical

Outcomes

Primary outcome [1]

Stillbirth at 28 weeks’ or more in singleton pregnancies without lethal fetal congenital abnormalities. Routinely collected perinatal data.

Timepoint [1]

15 years' pre-implementation and 2 years' post-implementation

Secondary outcome [1]

Women’s knowledge of stillbirth risk factors and experience and acceptability of SBB- subset of at least 2,300 women: Survey specifically designed for this study, using a combination of Likert rating scales, multiple choice, and open-ended questions.

Timepoint [1]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [2]

Clinicians' knowledge of stillbirth risk factors and best practice care of women with risk factors and acceptability of SBB- subset of 6,000 clinicians: Surveys specifically designed for this study, using a combination of Likert and rating scales, multiple choice, and open-ended questions.

Timepoint [2]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [3]

Health service utilisation - subset of 30 sites: Assessed via routinely collected data for inpatient and outpatient service use and surveys of maternity service managers specifically designed for this study, using a combination of Likert and rating scales, multiple choice, and open-ended questions.

Timepoint [3]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [4]

Adverse neonatal outcome - Composite measure of birth outcomes including Apgar Score <7 at 5 minutes; umbilical artery pH <7.0; intubation and ventilation at birth; hypoxic ischemic encephalopathy; neonatal seizures; Meconium Aspiration Syndrome; neonatal intensive care greater than 5 days; use of mechanical ventilation; neonatal death.

Timepoint [4]

15 years' pre-implementation, baseline and 2 years' post-implementation. Routinely collected perinatal data.

Secondary outcome [5]

Ecconomic Impact e.g. Incremental cost-effectiveness of the bundle compared to standard care, total and incremental costs to the health system, and total and incremental costs to society.- Medicare data on health care costs incurred through reimbursement for pharmaceutical benefits schedule (PBS) and medical benefits schedule (MBS).

Timepoint [5]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [6]

Percentage of women who cease smoking between first antenatal care visit and birth. Routinely collected perinatal data.

Timepoint [6]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [7]

Proportion of term births with undetected fetal growth restriction (FGR) defined as severely growth restricted singletons (less than 3rd centile) undelivered at 40 weeks’ gestation (missed FGR)- Routinely collected perinatal data.

Timepoint [7]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [8]

Percentage of women at 28 weeks’ gestation or more who attend a maternity service within 12 hours of decreased fetal movements (DFM) concern. - subset of 30 sites, using pre and post clinical audits (3000).

Timepoint [8]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [9]

Proportion of women who report safe sleep practices after 28 weeks’ gestation- subset of at least 2,300 women: Survey specifically designed for this study, using a combination of Likert and rating scales, multiple choice, and open-ended questions.

Timepoint [9]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Secondary outcome [10]

Proportion of women with singleton pregnancies who undergo induction of labour (IOL) or elective caesarean section (CS) before 39 weeks’ gestation. Routinely collected perinatal data.

Timepoint [10]

15 years' pre-implementation and 2 years' post-implementation

Secondary outcome [11]

Percentage of babies admitted to neonatal intensive care units after 36 completed weeks. Routinely collected perinatal data.

Timepoint [11]

15 years' pre-implementation and 2 years' post-implementation

Secondary outcome [12]

Rate of late preterm births. Routinely collected perinatal data

Timepoint [12]

15 years' pre-implementation and 2 years' post-implementation

Secondary outcome [13]

Rate of caesarean sections. Routinely collected perinatal data

Timepoint [13]

15 years' pre-implementation and 2 years' post-implementation

Secondary outcome [14]

Process measures specific to each of the five SBB elements will inform implementation fidelity and evaluation strategy. Measures will be derived from routinely collected data, clinical audits and surveys designed specifically for this study of women and clinicians.

Timepoint [14]

Baseline and end of study implementation period (up to 2.5 years after baseline). The implementation period will differ by jurisdiction from 12 to 24 months post launching.

Eligibility

Key inclusion criteria

Women with a singleton pregnancy without lethal fetal abnormalities attending for antenatal care and midwives and doctors providing maternity care at the participating hospitals.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Pregnant women with a lethal fetal congenital abnormality. Women who have a stillbirth or neonatal death prior to discharge from the hospital of birth will be excluded from the surveys of women around care practices.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Based on the most recent 3 year period prior to the SBB rollout, for which data are currently available (2016-2018), the late gestation stillbirth rate in Australia was 2.4 per 1000 births (unpublished data Stillbirth CRE). This decreased from 2.7 per 1000 births in 2013-20156. The SBB initiative aims to amplify and sustain a further rate reduction of at least 20% to target a rate of 1.9 per 1000 births by the end of 2023. Maintaining a downward pressure on rates is challenging given that as rates get lower further reductions may become increasingly more difficult to attain.

Based on 113,000 births per year across implementing sites, the study will be able to estimate a stillbirth rate of 1.9 to a precision of 1.7 to 2.1, with 95% confidence: 430 stillbirths out of 113,000 x 2 =1.9 per 1000 births. Put another way, the project will have 95% power (alpha=5%, two-sided) to show that an achieved stillbirth rate of 1.9 per 1000 births (the target for 2022-2023) is statistically significantly different from a stillbirth rate of 2.4 per 1000 births (pre-implementation for 2016-2018).

Secondary endpoints including obstetric intervention and other important maternal and newborn outcomes measurable using routine data are essentially safety endpoints and will be analysed using trend analysis, similar to the pre-specified primary endpoint. Formal power calculations have not been done because of the problem of statistical multiplicity. Point estimates for these secondary endpoints will be checked to confirm they support the result for the primary endpoint. Any outlying results will be investigated.

Other secondary measures will be compared pre and post implementation commencing before and at the end of the implementation periods including data from surveys of women and health care professionals and clinical audits. Subgroup analysis will also explore variations in the provision of antenatal care and disparities in stillbirth rates and other clinical outcomes for Aboriginal and Torres Strait Islander, migrant and refugee, and rural and remote women.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

10/06/2019

Date of last participant enrolment

Anticipated

3/03/2025

Actual

Date of last data collection

Anticipated

3/03/2025

Actual

Sample size

Target

235000

Accrual to date

16157

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

Albury Wodonga Health - Albury campus - Albury

Recruitment hospital [2]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment hospital [3]

Benalla Health - Benalla

Recruitment hospital [4]

Bendigo Health Care Group - Bendigo Hospital - Bendigo

Recruitment hospital [5]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [6]

Djerriwarrh Health Service - Bacchus Marsh - Bacchus Marsh

Recruitment hospital [7]

East Grampians Health Service - Ararat - Ararat

Recruitment hospital [8]

Angliss Hospital - Upper Ferntree Gully

Recruitment hospital [9]

Box Hill Hospital - Box Hill

Recruitment hospital [10]

Echuca Regional Health - Echuca

Recruitment hospital [11]

Latrobe Regional Hospital - Traralgon

Recruitment hospital [12]

Maryborough District Health Service (Maryborough) - Maryborough

Recruitment hospital [13]

Mercy Hospital for Women - Heidelberg

Recruitment hospital [14]

Casey Hospital - Berwick

Recruitment hospital [15]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [16]

Dandenong Hospital - Dandenong

Recruitment hospital [17]

The Northern Hospital - Epping

Recruitment hospital [18]

Frankston Hospital - Frankston

Recruitment hospital [19]

The Royal Women's Hospital - Parkville

Recruitment hospital [20]

Southwest Health Care - Warrnambool - Warrnambool

Recruitment hospital [21]

St Vincent's Private Hospital - Fitzroy

Recruitment hospital [22]

Werribee Mercy Hospital - Werribee

Recruitment hospital [23]

West Gippsland Healthcare Group - Warragul

Recruitment hospital [24]

Bowral Hospital - Bowral

Recruitment hospital [25]

Campbelltown Hospital - Campbelltown

Recruitment hospital [26]

Fairfield Hospital - Prairiewood

Recruitment hospital [27]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [28]

Liverpool Hospital - Liverpool

Recruitment hospital [29]

Belmont Hospital - Belmont

Recruitment hospital [30]

Glen Innes District Hospital - Glen Innes

Recruitment hospital [31]

Gloucester Soldiers Memorial Hospital - Gloucester

Recruitment hospital [32]

Singleton District Hospital - Singleton

Recruitment hospital [33]

Gunnedah District Hospital - Gunnedah

Recruitment hospital [34]

Inverell District Hospital - Inverell

Recruitment hospital [35]

Moree District Hospital - Moree

Recruitment hospital [36]

Muswellbrook Hospital - Muswellbrook

Recruitment hospital [37]

Narrabri District Hospital - Narrabri

Recruitment hospital [38]

Scott Memorial Hospital, Scone - Scone

Recruitment hospital [39]

Tamworth Rural Referral Hospital - Tamworth

Recruitment hospital [40]

Manning Rural Referral Hospital (Taree) - Taree

Recruitment hospital [41]

Armidale Rural Referral Hospital - Armidale

Recruitment hospital [42]

The Maitland Hospital - Maitland

Recruitment hospital [43]

John Hunter Hospital - New Lambton

Recruitment hospital [44]

Auburn Hospital & Community Health Services - Auburn

Recruitment hospital [45]

Blacktown Hospital - Blacktown

Recruitment hospital [46]

Westmead Hospital - Westmead

Recruitment hospital [47]

Wyong Public Hospital - Hamlyn Terrace

Recruitment hospital [48]

Gosford Hospital - Gosford

Recruitment hospital [49]

Mater Mother's Hospital - South Brisbane

Recruitment hospital [50]

Gold Coast University Hospital - Southport

Recruitment hospital [51]

Thursday Island Hospital - Thursday Island

Recruitment hospital [52]

Cooktown Hospital - Cooktown

Recruitment hospital [53]

Ipswich Hospital - Ipswich

Recruitment hospital [54]

Logan Hospital - Meadowbrook

Recruitment hospital [55]

Beaudesert Hospital - Beaudesert

Recruitment hospital [56]

Redland Hospital - Cleveland

Recruitment hospital [57]

Caboolture Hospital - Caboolture

Recruitment hospital [58]

Toowoomba Hospital - Toowoomba

Recruitment hospital [59]

Kingaroy Hospital & Community Health Centre - Kingaroy

Recruitment hospital [60]

Dalby Hospital Health Service - Dalby

Recruitment hospital [61]

Goondiwindi Hospital - Goondiwindi

Recruitment hospital [62]

Warwick Hospital - Warwick

Recruitment hospital [63]

Stanthorpe Hospital - Stanthorpe

Recruitment hospital [64]

Charleville Hospital - Charleville

Recruitment hospital [65]

Roma Hospital - Roma

Recruitment hospital [66]

St George Hospital - Kogarah

Recruitment hospital [67]

Mackay Base Hospital - Mackay

Recruitment hospital [68]

Rockhampton Base Hospital - Rockhampton

Recruitment hospital [69]

Gladstone Hospital - Gladstone

Recruitment hospital [70]

Emerald Hospital - Emerald

Recruitment hospital [71]

Biloela Hospital - Biloela

Recruitment hospital [72]

Cairns Base Hospital - Cairns

Recruitment postcode(s) [1]

2640 - Albury

Recruitment postcode(s) [2]

3350 - Ballarat Central

Recruitment postcode(s) [3]

3672 - Benalla

Recruitment postcode(s) [4]

3550 - Bendigo

Recruitment postcode(s) [5]

3144 - Malvern

Recruitment postcode(s) [6]

3340 - Bacchus Marsh

Recruitment postcode(s) [7]

3377 - Ararat

Recruitment postcode(s) [8]

3156 - Upper Ferntree Gully

Recruitment postcode(s) [9]

3128 - Box Hill

Recruitment postcode(s) [10]

3564 - Echuca

Recruitment postcode(s) [11]

3844 - Traralgon

Recruitment postcode(s) [12]

3465 - Maryborough

Recruitment postcode(s) [13]

3084 - Heidelberg

Recruitment postcode(s) [14]

3806 - Berwick

Recruitment postcode(s) [15]

3168 - Clayton

Recruitment postcode(s) [16]

3175 - Dandenong

Recruitment postcode(s) [17]

3076 - Epping

Recruitment postcode(s) [18]

3199 - Frankston

Recruitment postcode(s) [19]

3052 - Parkville

Recruitment postcode(s) [20]

3280 - Warrnambool

Recruitment postcode(s) [21]

3065 - Fitzroy

Recruitment postcode(s) [22]

3030 - Werribee

Recruitment postcode(s) [23]

3820 - Warragul

Recruitment postcode(s) [24]

2576 - Bowral

Recruitment postcode(s) [25]

2560 - Campbelltown

Recruitment postcode(s) [26]

2176 - Prairiewood

Recruitment postcode(s) [27]

2200 - Bankstown

Recruitment postcode(s) [28]

2170 - Liverpool

Recruitment postcode(s) [29]

2280 - Belmont

Recruitment postcode(s) [30]

2370 - Glen Innes

Recruitment postcode(s) [31]

2422 - Gloucester

Recruitment postcode(s) [32]

2330 - Singleton

Recruitment postcode(s) [33]

2380 - Gunnedah

Recruitment postcode(s) [34]

2360 - Inverell

Recruitment postcode(s) [35]

2400 - Moree

Recruitment postcode(s) [36]

2333 - Muswellbrook

Recruitment postcode(s) [37]

2390 - Narrabri

Recruitment postcode(s) [38]

2337 - Scone

Recruitment postcode(s) [39]

2340 - Tamworth

Recruitment postcode(s) [40]

2430 - Taree

Recruitment postcode(s) [41]

2350 - Armidale

Recruitment postcode(s) [42]

2320 - Maitland

Recruitment postcode(s) [43]

2305 - New Lambton

Recruitment postcode(s) [44]

2144 - Auburn

Recruitment postcode(s) [45]

2148 - Blacktown

Recruitment postcode(s) [46]

2145 - Westmead

Recruitment postcode(s) [47]

2259 - Hamlyn Terrace

Recruitment postcode(s) [48]

2250 - Gosford

Recruitment postcode(s) [49]

4101 - South Brisbane

Recruitment postcode(s) [50]

4215 - Southport

Recruitment postcode(s) [51]

4875 - Thursday Island

Recruitment postcode(s) [52]

4895 - Cooktown

Recruitment postcode(s) [53]

4305 - Ipswich

Recruitment postcode(s) [54]

4131 - Meadowbrook

Recruitment postcode(s) [55]

4285 - Beaudesert

Recruitment postcode(s) [56]

4163 - Cleveland

Recruitment postcode(s) [57]

4510 - Caboolture

Recruitment postcode(s) [58]

4350 - Toowoomba

Recruitment postcode(s) [59]

4610 - Kingaroy

Recruitment postcode(s) [60]

4405 - Dalby

Recruitment postcode(s) [61]

4390 - Goondiwindi

Recruitment postcode(s) [62]

4370 - Warwick

Recruitment postcode(s) [63]

4380 - Stanthorpe

Recruitment postcode(s) [64]

4470 - Charleville

Recruitment postcode(s) [65]

4455 - Roma

Recruitment postcode(s) [66]

2217 - Kogarah

Recruitment postcode(s) [67]

4740 - Mackay

Recruitment postcode(s) [68]

4700 - Rockhampton

Recruitment postcode(s) [69]

4680 - Gladstone

Recruitment postcode(s) [70]

4720 - Emerald

Recruitment postcode(s) [71]

4715 - Biloela

Recruitment postcode(s) [72]

4870 - Cairns

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Safer Care Victoria, Victorian Agency for Health Information

Address [2]

50 Lonsdale Street, Melbourne VIC 3000

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Clinical Excellence Commission, NSW Government

Address [3]

Level 17, McKell Building
2-24 Rawson Place, Sydney NSW 2000

Country [3]

Australia

Funding source category [4]

Government body

Name [4]

Clinical Excellence Queensland, Queensland Health

Address [4]

5 Butterfield Street
Herston Queensland 4006

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Stillbirth Foundation Australia

Address [5]

Suite 105, 283 Alfred St, North Sydney, NSW, 2060

Country [5]

Australia

Funding source category [6]

Charities/Societies/Foundations

Name [6]

Still Aware

Address [6]

Level 2, 8 Greenhill Road, Wayville SA 5034

Country [6]

Australia

Primary sponsor type

Individual

Name

Professor Vicki Flenady

Address

Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane & Women’s Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2019

Approval date [1]

04/06/2019

Ethics approval number [1]

HREC/2019/QRBW/47709

Summary

Brief summary

Stillbirth directly affects over 2,000 families in Australia each year. Stillbirth is a personal tragedy for the families involved and a serious public health problem with far reaching social, emotional and financial burdens on all involved. In many cases stillbirth is preventable and research shows 20-30% of late gestation stillbirths could be avoided with better care. 
The Safer Baby Bundle (SBB) was developed to address priority evidence practice gaps in stillbirth prevention. This before and after study evaluates the impact of this healthcare improvement initiative across maternity services in three states; Queensland, Victoria and New South Wales. By implementing the SBB elements of care, the goal is to reduce stillbirth in Australia by 20% for women from 28 weeks’ gestation and beyond.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Vicki Flenady

Address

Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101

Country

Australia

Phone

+61 07 31631592

Fax

[email protected]

Contact person for public queries

Name

Christine Andrews

Address

Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Australia

Country

Australia

Phone

+61 07 31635344

Fax

[email protected]

Contact person for scientific queries

Name

Vicki Flenady

Address

Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101

Country

Australia

Phone

+61 07 31631592

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Aggregate data only will be available researchers upon appropriate request and approval of the chief investigator, ethics committee and study steering committee.

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