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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
16/12/2019
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. The study timeline is necessarily pragmatic to account for disparities in implementation start dates between jurisdictions. The implementation period (which includes pre and post implementation data collection as part of the implementation strategy) will run for 18 months, followed by a three-year post-implementation phase. Victoria commenced implementation in June 2019 and the other states will commence early 2020.

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. An interrupted time series analysis will examine the change in stillbirth rates (and other adverse neonatal outcomes) comparing 15-years pre-implementation with the rate in the three-year post-implementation period, using State level routinely collected perinatal data. 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 3 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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 3 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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,
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 3 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 3 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 3 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 3 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 implementation period (12 or 18 months after baseline). The implementation period will differ by jurisdiction from 12 to 18 months,

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
Gender
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
A time series analysis will examine the change in stillbirth rates comparing 15-years pre-implementation (2.6 million births) with the rate in 525,600 births in the three-year post-implementation period, using routinely collected perinatal data. 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.
Sample size was calculated as follows- 175, 200 births annually across the 99 eligible hospitals will provide 2.6 million births in the 15-year pre-implementation period and 525, 600 births in the 3-year post-implementation period. The rate of stillbirths for gestations 28+ weeks is currently 3 per 1000 births (525 births per year or 7884 stillbirths in the 15-year pre-implementation period). We hypothesise the implementation of the SBB will reduce the risk of stillbirth by 20% to 2.4/1000 births, giving 420 stillbirths per year (reduction approx. 100 stillbirths/year) or 1260 stillbirths in the 3-year post-implementation. Using standard simulation methods for trend analysis (by year), with a joinpoint using Poisson regression (with adjustment for potential confounders, as below), this sample size will provide 81% power to detect the 20% decrease in the event rate (from 3/1000 to 2.4/1000), associated with the implementation (alpha= 0.05, 2-sided). Poisson regression will be used with a 15-year pre-implementation period to ensure that any detected effect of the implementation is not a long-term temporal trend. Adjustments for potential confounders will be undertaken (e.g., fixed effects: maternal age, smoking rates, pre-existing maternal conditions, and pregnancy complications, socioeconomic status; random effect: hospital). Descriptive statistics will be used to summarise data such as demographic characteristics. Analysis will be carried out using Stata.

Recruitment
Recruitment status
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)
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 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

Funding & Sponsors
Funding source category [1] 304312 0
Government body
Name [1] 304312 0
National Health and Medical Research Council
Address [1] 304312 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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
Address [2] 304316 0
50 Lonsdale Street, Melbourne VIC 3000
Country [2] 304316 0
Australia
Funding source category [3] 304317 0
Government body
Name [3] 304317 0
Clinical Excellence Commission, NSW Government
Address [3] 304317 0
Level 17, McKell Building
2-24 Rawson Place, Sydney NSW 2000
Country [3] 304317 0
Australia
Funding source category [4] 304318 0
Government body
Name [4] 304318 0
Clinical Excellence Queensland, Queensland Health
Address [4] 304318 0
5 Butterfield Street
Herston Queensland 4006
Country [4] 304318 0
Australia
Funding source category [5] 304319 0
Charities/Societies/Foundations
Name [5] 304319 0
Stillbirth Foundation Australia
Address [5] 304319 0
Suite 105, 283 Alfred St, North Sydney, NSW, 2060
Country [5] 304319 0
Australia
Funding source category [6] 304320 0
Charities/Societies/Foundations
Name [6] 304320 0
Still Aware
Address [6] 304320 0
Level 2, 8 Greenhill Road, Wayville SA 5034
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
Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
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
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 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
vicki.flenady@mater.uq.edu.au
Contact person for public queries
Name 98131 0
Dr 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
christine.andrews@mater.uq.edu.au
Contact person for scientific queries
Name 98132 0
Prof 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
vicki.flenady@mater.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics not provided for sharing sensitive participant and hospital data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results