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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] 299854 0
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 315251 0
Fetal death 315441 0
Condition category
Condition code
Reproductive Health and Childbirth 313558 313558 0 0
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] 316244 0
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] 322015 0
Stillbirth at 28 weeks’ or more in singleton pregnancies without lethal fetal congenital abnormalities. Routinely collected perinatal data.
Timepoint [1] 322015 0
15 years' pre-implementation and 2 years' post-implementation
Secondary outcome [1] 377004 0
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] 377004 0
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] 377005 0
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] 377005 0
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] 377006 0
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] 377006 0
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] 377007 0
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] 377007 0
15 years' pre-implementation, baseline and 2 years' post-implementation. Routinely collected perinatal data.
Secondary outcome [5] 377008 0
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] 377008 0
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] 377009 0
Percentage of women who cease smoking between first antenatal care visit and birth. Routinely collected perinatal data.
Timepoint [6] 377009 0
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] 377010 0
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] 377010 0
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] 377011 0
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] 377011 0
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] 377012 0
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] 377012 0
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] 377013 0
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] 377013 0
15 years' pre-implementation and 2 years' post-implementation
Secondary outcome [11] 377014 0
Percentage of babies admitted to neonatal intensive care units after 36 completed weeks. Routinely collected perinatal data.
Timepoint [11] 377014 0
15 years' pre-implementation and 2 years' post-implementation
Secondary outcome [12] 377015 0
Rate of late preterm births. Routinely collected perinatal data
Timepoint [12] 377015 0
15 years' pre-implementation and 2 years' post-implementation
Secondary outcome [13] 377016 0
Rate of caesarean sections. Routinely collected perinatal data
Timepoint [13] 377016 0
15 years' pre-implementation and 2 years' post-implementation
Secondary outcome [14] 377017 0
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] 377017 0
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] 15190 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 15191 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [3] 15192 0
Benalla Health - Benalla
Recruitment hospital [4] 15193 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [5] 15195 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [6] 15196 0
Djerriwarrh Health Service - Bacchus Marsh - Bacchus Marsh
Recruitment hospital [7] 15197 0
East Grampians Health Service - Ararat - Ararat
Recruitment hospital [8] 15198 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [9] 15199 0
Box Hill Hospital - Box Hill
Recruitment hospital [10] 15200 0
Echuca Regional Health - Echuca
Recruitment hospital [11] 15201 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [12] 15202 0
Maryborough District Health Service (Maryborough) - Maryborough
Recruitment hospital [13] 15203 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [14] 15204 0
Casey Hospital - Berwick
Recruitment hospital [15] 15205 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [16] 15206 0
Dandenong Hospital - Dandenong
Recruitment hospital [17] 15207 0
The Northern Hospital - Epping
Recruitment hospital [18] 15208 0
Frankston Hospital - Frankston
Recruitment hospital [19] 15209 0
The Royal Women's Hospital - Parkville
Recruitment hospital [20] 15210 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [21] 15212 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [22] 15213 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [23] 15214 0
West Gippsland Healthcare Group - Warragul
Recruitment hospital [24] 15215 0
Bowral Hospital - Bowral
Recruitment hospital [25] 15216 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [26] 15217 0
Fairfield Hospital - Prairiewood
Recruitment hospital [27] 15218 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [28] 15219 0
Liverpool Hospital - Liverpool
Recruitment hospital [29] 15220 0
Belmont Hospital - Belmont
Recruitment hospital [30] 15221 0
Glen Innes District Hospital - Glen Innes
Recruitment hospital [31] 15222 0
Gloucester Soldiers Memorial Hospital - Gloucester
Recruitment hospital [32] 15223 0
Singleton District Hospital - Singleton
Recruitment hospital [33] 15226 0
Gunnedah District Hospital - Gunnedah
Recruitment hospital [34] 15227 0
Inverell District Hospital - Inverell
Recruitment hospital [35] 15228 0
Moree District Hospital - Moree
Recruitment hospital [36] 15229 0
Muswellbrook Hospital - Muswellbrook
Recruitment hospital [37] 15230 0
Narrabri District Hospital - Narrabri
Recruitment hospital [38] 15231 0
Scott Memorial Hospital, Scone - Scone
Recruitment hospital [39] 15232 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [40] 15234 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [41] 15235 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [42] 15236 0
The Maitland Hospital - Maitland
Recruitment hospital [43] 15237 0
John Hunter Hospital - New Lambton
Recruitment hospital [44] 15238 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [45] 15239 0
Blacktown Hospital - Blacktown
Recruitment hospital [46] 15240 0
Westmead Hospital - Westmead
Recruitment hospital [47] 15241 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [48] 15242 0
Gosford Hospital - Gosford
Recruitment hospital [49] 15243 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [50] 15246 0
Gold Coast University Hospital - Southport
Recruitment hospital [51] 15247 0
Thursday Island Hospital - Thursday Island
Recruitment hospital [52] 15248 0
Cooktown Hospital - Cooktown
Recruitment hospital [53] 15249 0
Ipswich Hospital - Ipswich
Recruitment hospital [54] 15250 0
Logan Hospital - Meadowbrook
Recruitment hospital [55] 15251 0
Beaudesert Hospital - Beaudesert
Recruitment hospital [56] 15252 0
Redland Hospital - Cleveland
Recruitment hospital [57] 15253 0
Caboolture Hospital - Caboolture
Recruitment hospital [58] 15254 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [59] 15255 0
Kingaroy Hospital & Community Health Centre - Kingaroy
Recruitment hospital [60] 15256 0
Dalby Hospital Health Service - Dalby
Recruitment hospital [61] 15257 0
Goondiwindi Hospital - Goondiwindi
Recruitment hospital [62] 15258 0
Warwick Hospital - Warwick
Recruitment hospital [63] 15259 0
Stanthorpe Hospital - Stanthorpe
Recruitment hospital [64] 15260 0
Charleville Hospital - Charleville
Recruitment hospital [65] 15261 0
Roma Hospital - Roma
Recruitment hospital [66] 15262 0
St George Hospital - Kogarah
Recruitment hospital [67] 15263 0
Mackay Base Hospital - Mackay
Recruitment hospital [68] 15264 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [69] 15265 0
Gladstone Hospital - Gladstone
Recruitment hospital [70] 15266 0
Emerald Hospital - Emerald
Recruitment hospital [71] 15267 0
Biloela Hospital - Biloela
Recruitment hospital [72] 21779 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 28499 0
2640 - Albury
Recruitment postcode(s) [2] 28500 0
3350 - Ballarat Central
Recruitment postcode(s) [3] 28501 0
3672 - Benalla
Recruitment postcode(s) [4] 28502 0
3550 - Bendigo
Recruitment postcode(s) [5] 28504 0
3144 - Malvern
Recruitment postcode(s) [6] 28505 0
3340 - Bacchus Marsh
Recruitment postcode(s) [7] 28506 0
3377 - Ararat
Recruitment postcode(s) [8] 28507 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [9] 28508 0
3128 - Box Hill
Recruitment postcode(s) [10] 28509 0
3564 - Echuca
Recruitment postcode(s) [11] 28510 0
3844 - Traralgon
Recruitment postcode(s) [12] 28511 0
3465 - Maryborough
Recruitment postcode(s) [13] 28512 0
3084 - Heidelberg
Recruitment postcode(s) [14] 28513 0
3806 - Berwick
Recruitment postcode(s) [15] 28514 0
3168 - Clayton
Recruitment postcode(s) [16] 28515 0
3175 - Dandenong
Recruitment postcode(s) [17] 28516 0
3076 - Epping
Recruitment postcode(s) [18] 28517 0
3199 - Frankston
Recruitment postcode(s) [19] 28518 0
3052 - Parkville
Recruitment postcode(s) [20] 28519 0
3280 - Warrnambool
Recruitment postcode(s) [21] 28521 0
3065 - Fitzroy
Recruitment postcode(s) [22] 28522 0
3030 - Werribee
Recruitment postcode(s) [23] 28523 0
3820 - Warragul
Recruitment postcode(s) [24] 28524 0
2576 - Bowral
Recruitment postcode(s) [25] 28525 0
2560 - Campbelltown
Recruitment postcode(s) [26] 28526 0
2176 - Prairiewood
Recruitment postcode(s) [27] 28527 0
2200 - Bankstown
Recruitment postcode(s) [28] 28528 0
2170 - Liverpool
Recruitment postcode(s) [29] 28529 0
2280 - Belmont
Recruitment postcode(s) [30] 28530 0
2370 - Glen Innes
Recruitment postcode(s) [31] 28531 0
2422 - Gloucester
Recruitment postcode(s) [32] 28532 0
2330 - Singleton
Recruitment postcode(s) [33] 28535 0
2380 - Gunnedah
Recruitment postcode(s) [34] 28536 0
2360 - Inverell
Recruitment postcode(s) [35] 28537 0
2400 - Moree
Recruitment postcode(s) [36] 28538 0
2333 - Muswellbrook
Recruitment postcode(s) [37] 28539 0
2390 - Narrabri
Recruitment postcode(s) [38] 28540 0
2337 - Scone
Recruitment postcode(s) [39] 28541 0
2340 - Tamworth
Recruitment postcode(s) [40] 28543 0
2430 - Taree
Recruitment postcode(s) [41] 28544 0
2350 - Armidale
Recruitment postcode(s) [42] 28545 0
2320 - Maitland
Recruitment postcode(s) [43] 28546 0
2305 - New Lambton
Recruitment postcode(s) [44] 28547 0
2144 - Auburn
Recruitment postcode(s) [45] 28548 0
2148 - Blacktown
Recruitment postcode(s) [46] 28549 0
2145 - Westmead
Recruitment postcode(s) [47] 28550 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [48] 28551 0
2250 - Gosford
Recruitment postcode(s) [49] 28552 0
4101 - South Brisbane
Recruitment postcode(s) [50] 28555 0
4215 - Southport
Recruitment postcode(s) [51] 28556 0
4875 - Thursday Island
Recruitment postcode(s) [52] 28557 0
4895 - Cooktown
Recruitment postcode(s) [53] 28558 0
4305 - Ipswich
Recruitment postcode(s) [54] 28559 0
4131 - Meadowbrook
Recruitment postcode(s) [55] 28560 0
4285 - Beaudesert
Recruitment postcode(s) [56] 28561 0
4163 - Cleveland
Recruitment postcode(s) [57] 28562 0
4510 - Caboolture
Recruitment postcode(s) [58] 28563 0
4350 - Toowoomba
Recruitment postcode(s) [59] 28564 0
4610 - Kingaroy
Recruitment postcode(s) [60] 28565 0
4405 - Dalby
Recruitment postcode(s) [61] 28566 0
4390 - Goondiwindi
Recruitment postcode(s) [62] 28567 0
4370 - Warwick
Recruitment postcode(s) [63] 28568 0
4380 - Stanthorpe
Recruitment postcode(s) [64] 28569 0
4470 - Charleville
Recruitment postcode(s) [65] 28570 0
4455 - Roma
Recruitment postcode(s) [66] 28571 0
2217 - Kogarah
Recruitment postcode(s) [67] 28572 0
4740 - Mackay
Recruitment postcode(s) [68] 28573 0
4700 - Rockhampton
Recruitment postcode(s) [69] 28574 0
4680 - Gladstone
Recruitment postcode(s) [70] 28575 0
4720 - Emerald
Recruitment postcode(s) [71] 28576 0
4715 - Biloela
Recruitment postcode(s) [72] 36836 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 304312 0
Government body
Name [1] 304312 0
National Health and Medical Research Council
Country [1] 304312 0
Australia
Funding source category [2] 304316 0
Government body
Name [2] 304316 0
Safer Care Victoria, Victorian Agency for Health Information
Country [2] 304316 0
Australia
Funding source category [3] 304317 0
Government body
Name [3] 304317 0
Clinical Excellence Commission, NSW Government
Country [3] 304317 0
Australia
Funding source category [4] 304318 0
Government body
Name [4] 304318 0
Clinical Excellence Queensland, Queensland Health
Country [4] 304318 0
Australia
Funding source category [5] 304319 0
Charities/Societies/Foundations
Name [5] 304319 0
Stillbirth Foundation Australia
Country [5] 304319 0
Australia
Funding source category [6] 304320 0
Charities/Societies/Foundations
Name [6] 304320 0
Still Aware
Country [6] 304320 0
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] 304559 0
None
Name [1] 304559 0
Address [1] 304559 0
Country [1] 304559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304766 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 304766 0
Ethics committee country [1] 304766 0
Australia
Date submitted for ethics approval [1] 304766 0
04/04/2019
Approval date [1] 304766 0
04/06/2019
Ethics approval number [1] 304766 0
HREC/2019/QRBW/47709

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98130 0
Prof Vicki Flenady
Address 98130 0
Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Country 98130 0
Australia
Phone 98130 0
+61 07 31631592
Fax 98130 0
Email 98130 0
[email protected]
Contact person for public queries
Name 98131 0
Christine Andrews
Address 98131 0
Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Australia
Country 98131 0
Australia
Phone 98131 0
+61 07 31635344
Fax 98131 0
Email 98131 0
[email protected]
Contact person for scientific queries
Name 98132 0
Vicki Flenady
Address 98132 0
Mater Research Institute - The University of Queensland
Level 3 Aubigny Place
Mater Health Services
South Brisbane QLD 4101
Country 98132 0
Australia
Phone 98132 0
+61 07 31631592
Fax 98132 0
Email 98132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.