Priority Area One

Improving care and outcomes for women with risk factors for stillbirth

Priority Area One leads: Professor Vicki Flenady, Professor David Ellwood, Dr Adrienne Gordon

 

This priority area focuses on research to enable informed decision-making in the care of women during pregnancy to avoid stillbirth and other adverse newborn outcomes. The current lack of an individualised evidence-based approach to a woman’s risk status has resulted in concerning increases in early term and late preterm birth. Indigenous and other disadvantaged groups often have constellations of risk factors (e.g. obesity, smoking, substance use, inadequate nutrition) and poor antenatal care attendance.

  • The Australian Safer Baby Bundle

    Study Team: Vicki Flenady, Philippa Middleton, David Ellwood, Adrienne Gordon, Michael Nicholl, Caroline Homer,  Jonathan Morris, Glenn Gardener, Michael Coory, Miranda Davies-Tuck, Fran Boyle, Emily Callander, Christine Andrews

     

    Implementation partners: Clinical Excellence Commission NSW, Clinical Excellence QLD, Safer Care Victoria, Stillbirth Foundation Australia. 

     

    The Safer Baby Bundle will initially be implemented by the health departments across Victoria, Queensland and New South Wales. Educational programs for health care providers have been developed including the Bundle elearning program . All resources are based on the best available evidence as summarised in the position statements and guidelines.

    Through additional MRFF funding, the Bundle is currently being up scaled nationally. This work aims to engage health departments and communities across Australia to research and develop resources for the Safer Baby Bundle that meet the needs of Indigenous communities, families in rural and remote locations, and culturally and are:

    The Bundle evaluations objectives are as follows:

    Primary:

    To implement and evaluate the impact of a maternity care Safe Baby Bundle (SBB ) which addresses priority care practices for Australian maternity settings on stillbirth rates after 28 weeks’ gestation.

    Secondary:

    1. To compare before and after the implementation of the SBB:

    • rates of obstetric intervention and other important maternal and newborn outcomes
    • rates of key performance indicators (KPI) and other process outcome measures
    • women’s psychosocial outcomes and reported outcomes relating to care
    • clinicians’ knowledge and confidence in clinical care practices of the bundle elements

    2. To assess the impact of the bundle on hospital resource use and outcomes by level of implementation and the influence of leadership, governance and culture on implementation
    3. To assess a mobile phone app for women relating to the SBB on knowledge of bundle components, health seeking behaviours, confidence and self-efficacy
    To undertake an economic evaluation of the care bundle.

    For more information, visit the Safer Baby Bundle page.

    Funding: NHMRC Partnership Grant

    Funding: Medical Research Future Fund – Accelerated Research Grant

  • Together We Can Stop Stillbirth: Education Campaign around the Safer Baby Bundle

    Study Team:  Stillbirth CRE, Stillbirth Foundation Australia, Multicultural Centre for Women’s Health, Perinatal Society of Australia and New Zealand, Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Red Nose, Sands, Rural Health Network

     

    This project includes development and evaluation of a public education campaign across Australia. Our approach aims to improve health outcomes through making the evidenced-based resources of the Bundle, widely accessible to all women with a focus on higher risk and under-served populations. It will provide accurate advice about prevention, through co-designed initiatives, using interactive technology and innovative service delivery models.

    This project forms part of the overarching Stillbirth Education and Awareness Grant Opportunity (GO2536)” grant with the Public Awareness campaign component led by Red Nose in partnership with Stillbirth CRE, SBFA and Sands.

    A major component of this work is to develop and test decision-support tools for women and care providers on timing of birth in relation to stillbirth prevention including an educational program for clinicians (please refer to study 'Developing an individualised risk assessment tool for women at term').

    The project also includes a number of studies aimed at improving information for women from Migrant and Refugee and Indigenous communities (please see studies 'A new stillbirth prevention module for migrant and refugee women' and 'Adaptation and implementation of the Safer Baby Bundle for Indigenous women').

    Funding: Primary Health Care Development Program -- Stillbirth Education and Awareness Grant Opportunity (GO2536), Department of Health

  • Together We Can Stop Stillbirth: Evaluation of the public awareness campaign around stillbirth

    Study Team: Adrienne Gordon, Vicki Flenady, Adrian Bauman, Keren Ludski (Red Nose), Jackie Mead(Sands), Leigh Brezler (Stillbirth Foundation Australia)

     

    This project forms part of the overarching Stillbirth Education and Awareness Grant Opportunity (GO2536)” grant with the Public Awareness campaign component led by Red Nose in partnership with Stillbirth CRE, Stillbirth Foundation Australia and Sands.

    The evaluation will assess the campaign effects on empowering women and increasing community awareness of stillbirth.

    Funding: Primary Health Care Development Program -- Stillbirth Education and Awareness Grant Opportunity (GO2536), Department of Health

  • Adaptation and implementation of an Australian version of the UK’s ‘Baby Buddy App’

    Led by Adrienne Gordon, University of Sydney

     

    Using an embedding approach in selected maternity services focusing on women at highest risk we will modify the UK’s ‘Baby Buddy App’ for use in Australia.

    Funding: Primary Health Care Development Program -- Stillbirth Education and Awareness Grant Opportunity (GO2536), Department of Health

  • A new stillbirth prevention module for migrant and refugee women

    Led by Adele Murdolo, Centre for Multicultural Women’s Health

     

    This project seeks to increase awareness among migrant women who are at high risk of stillbirth about the benefits of preventative health, early intervention and antenatal care, and build capacity among migrant women who are at high risk of stillbirth to access antenatal care in the first trimester The study will women across metro and rural Victoria.

    Funding: Primary Health Care Development Program -- Stillbirth Education and Awareness Grant Opportunity (GO2536), Department of Health

  • The ECLIPSE study

    Led by Jane Yelland, Murdoch Children’s Research Institute.

    The ECLIPSE study addresses the need for tailored strategies in public maternity hospitals for pregnant women with low English proficiency. It will test the introduction of audio-recorded antenatal consultations within a framework of community and service co-design and implementation. It will deliver Safer Baby Bundle resources to women with low English proficiency in public maternity hospitals in Victoria using audio-recorded antenatal consultations through the Murdoch Children’s Research Institute.

    Funding: Primary Health Care Development Program -- Stillbirth Education and Awareness Grant Opportunity (GO2536), Department of Health

  • Living Literacy program

    Led by Danielle Muscat and Camille Raynes-Greenow, University of Sydney

     

    The Living Literacy program will be adapted for a CALD antenatal setting, with a specific focus on improving primigravid women’s health literacy skills (i.e. skills to access, understand, appraise and use health information) to support stillbirth risk reduction focussing on the Safer Baby Bundle elements of care. This study will adapt an existing group based health literacy program for culturally and linguistically diverse (CALD) pregnant women in NSW, University of Sydney.

    Funding: Primary Health Care Development Program -- Stillbirth Education and Awareness Grant Opportunity (GO2536), Department of Health

  • Developing an individualised risk assessment tool for women at term

    Study Team: Prof David Ellwood, Prof Vicki Flenady, A/Prof Sean Seeho, Megan Weller, Jess Sexton (PhD)

     

    This study draws on the estimated stillbirth risk by week of gestation as derived from the national data (see 'Epidemiology of Stillbirth in Australia'). The principles of EBCD methodology will be used to develop the Safer Baby Bundle (SBB) resources. A major area of focus is resources for the SBB timing of birth element (SBB Element 5) which is anticipated to include a clinical care pathway, materials to support women’s informed decision-making and a clinician education program.  Guided by the Australian EBCD Toolkit and building on consultation that has already occurred, the key steps in this process will be as follows:

    1. recruitment of a group of clinicians (midwives and doctors) and parents (approximately 15- 20 in each group);

    2. one-to-one interviews and focus groups to gather information about their experiences relevant to SBB elements.

    3. sharing of the information gathered in a facilitated combined meeting to agree on key aspects of care with a focus on the SBB timing of birth element;

    4. co-design meetings to develop and refine resources;

    5. a celebration event on the achievements. Women who have recently birthed (within previous 6 months) and midwives and doctors at selected participating services across each of the three jurisdictions involved in the SBB implementation will be invited to participate.

    Engagement with Indigenous and CALD women and their care providers will be overseen by the Stillbirth CRE’s Indigenous and CALD Advisory Groups.

  • Preventing Term Stillbirth in South Asian Born Mothers

    Study Team:  Euan Wallace, Miranda Davies-Tuck

     

    Despite decreases in the rates of both neonatal death and SIDS, the rate of stillbirth has remained largely unchanged in Australia for well over a decade. One group of women who have a much higher rate of stillbirth than other women giving birth in Australia are south Asian born women. Previous work from our investigators have shown that not only is the rate of stillbirth at the end of pregnancy significantly higher in South Asian women (i.e. India, Pakistan, Sri Lanka, Afghanistan and Bangladesh) than Australian-born women, the rate also increases earlier in pregnancy and more rapidly. This difference appears to be due to “accelerated placental ageing” in south Asian born women such that South Asian born women have shorter pregnancies and are more likely to have signs of fetal compromise at the end of pregnancy. Most maternity hospitals offer induction of labour or fetal surveillance for women whose pregnancy extends beyond 41 weeks. This is to reduce the risk of stillbirth. However, this may be too late for South Asian women.

    This project aims to assess the impact of a new clinical guideline of surveillance or induction of labour for South Asian women at 39 weeks.

  • Adaptation and implementation of the Safer Baby Bundle for Indigenous women

    Study Team: Philippa Middleton, through South Australian Health and Medical Research Institute (SAHMRI), Deanna Stuart Butler, Di Jans, Johanna Neville, Belinda Jennings

     

    With women participating in Aboriginal birthing programs in SA (Adelaide and Port Augusta), NT (Darwin and Tennant Creek), NSW (Tamworth) and Queensland (Cape York), we will co-produce and pilot culturally relevant resources for each of the five Safer Baby Bundle elements including the adaptation of the Baby Buddy phone app. This co-design work with communities will focus on key messages to prevent stillbirth and how health services and systems can improve care for women at high risk of stillbirth.

    Funding: Primary Health Care Development Program, Department of Health

  • The My Baby's Movements (MBM) trial

    mbm2

    Study Team:  Vicki Flenady, Glenn Gardener, Philippa Middleton, Michael Coory, David Ellwood, Caroline Crowther, Christine East, Emily Callander, Jane Norman, Fran Boyle

     

    My Baby’s Movements (MBM) is a mobile phone program delivered through an interactive app and SMS. The program is designed to help women understand their baby’s movements and encourages prompt contact with health care providers if any concerns arise. The study design used a stepped wedge cluster randomised controlled trial.

    The MBM trial was completed in May 2019. Full results of the trial, including its economic evaluation, will be published in 2020.

       >>Go to the published protocol for the MBM trial

    Funding: NHMRC Project Grant

  • Fetal movements individual participant data meta-analysis

    Study Team: Jane Norman, Alex Heazell, Lisa Askie, Philippa Middleton, Glenn Gardener, David Ellwood, Ingela Radestad, Michael Coory

     


    The objective of this study is to determine if interventions for increasing awareness of fetal movement decrease stillbirth rates without increasing adverse newborn and maternal outcomes by utilizing individual participant data meta-analysis (IPDMA).

    Selection criteria: All randomized controlled trials (RCTs) of pregnant women testing fetal movement awareness interventions versus standard care. Cluster RCT’s will be included; including the recently published AFFIRM trial and the My Baby’s Movements trials.

    We will search the literature for RCTs on the topic and ask investigators to share their individual participant data (IPD). Studies without available IPD will be excluded. The primary outcome is stillbirth at 28 weeks’ or more gestation.

  • Interventions for women with decreased or altered fetal movements; A Cochrane systematic review

    Study Team: Philippa Middleton, Vicki Flenady, Megan Weller, Miranda Davies-Tuck

     


    Interventions to improve outcomes for women with DFM focus on two areas; 1) improving screening and detection and 2) appropriate clinical management.


    1. Interventions to improve detection include: fetal movement monitoring devices; maternal fetal movement counting; educational intervention for women during pregnancy including provision of written materials or other forms of communication, mobile phone applications, and media campaigns. Fetal movement counting (where women record the number of movements using a kick chart) has been proposed as a method to improve accuracy of maternal reporting of DFM. Whether monitoring of fetal movements, using any approach, should be undertaken for all women or only those considered to be at increased risk of complications, and whether monitoring should be based on a formal counting method remains controversial.


    2. Various clinical strategies are currently in use to improve outcomes for women who have DFM. These include fetal surveillance (e.g. cardiotocography; ultrasound assessment including Doppler studies; clinical and cardiotocographic fetal arousal tests; and various combinations of tests); induction of labour; caesarean section; algorithms for assessment and management; and expectant management.

  • Antenatal interventions for preventing stillbirth; an overview of Cochrane systematic reviews

    Study Team: Erika Ota, Philippa Middleton, Vicki Flenady

     


    The objective of this overview is to summarise the evidence from Cochrane systematic reviews regarding the effects of antenatal interventions for preventing stillbirth during pregnancy.

  • Relationship between maternal asthma and adverse pregnancy outcomes

    Study Team: Vicki Clifton, Vicki Flenady, Jui Das (PhD)

     
    The primary objective of this project is to determine the pregnancy outcome and stillbirth among asthmatic pregnant women in Australia.


    A systematic review is ongoing and expected to assess the relationship between pregnancy asthma and outcomes. This review will use to inform the methods and approach to developing our final model. The final model will be developed using a large retrospective cohort study examining pregnancy outcomes among asthmatic women in Australia.

  • SliPP: A multi centre randomised trial assessing time spent in supine position during sleep in the third trimester of pregnancy with or without a position aid

    Study Team: Adrienne Gordon, Lesley McCowan, Ed Mitchell, Robin Cronin, Minglan Li, Vicki Culling, Tomasina Stacey, Alex Heazell, Lisa Askie, Peter Cistulli

     

    This trial will test whether advice alone compared to advice and a pillow device best supports non-supine sleep using the Night Shift device as an objective measure of both sleep duration and position. This design could also be employed in the future for a roll out of sleep position interventions, but crucially the optimum intervention would need to be properly validated, which is what this trial aims to do.

  • Developing Core Outcomes for Stillbirth (COSTIL)

    Study Team: Ben Mol, Bobae Kim, Vicki Flenady,  Philippa Middleton, Suzette Coat, Edoardo Aromataris

     

    The COSTIL (Core Outcomes in Stillbirth) project team is based at the University of Adelaide aiming to develop a standardised common outcome set that can be implemented across all clinical research in the field of prevention of stillbirth so that every study conducted can be easily compared and combined for better effective use. The project uses a two-stage approach to develop outcomes that reflect the priorities of all stakeholders. This encompasses previous literature through a systematic review, a focus group and interviews of parents who have experienced stillbirth, and a Delphi method that will combine and generate a consensus of opinions between experts in the field. Parent members of the Stillbirth Foundation for will also be engaged in the research to share their views on which outcomes they consider most important.

    This strategy will allow the many individual trials, reviews and guidelines in stillbirth to be effectively combined and compared, resulting in a significant contribution to future stillbirth mitigation. It is expected this research will have collaboration synergies with a team of researchers in UK funded by Stillbirth and Neonatal Death charity and SNDS. This work is funded by Stillbirth Foundation Australia.

    Funding: Stillbirth Foundation Australia

  • Epidemiology of Stillbirth in Australia

    Study Team: Vicki Flenady, Michael Coory, David Ellwood, Lisa Hilder, Adrienne Gordon, Georgina Chambers, Philippa Middleton, Kara Warrilow, Maria Makrides, Genevieve Molloy, Mike Beckman, Sailesh Kumar, Gordon Smith, Scott Lieske,  Camille Raynes-Greenow, Gavin Pereira, Jess Sexton (PhD), Anneka Bowman (PhD)

     

    A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to enable timely, appropriate care to reduce the risk of stillbirth at term. Stillbirth in late pregnancy is more likely to occur unexpectedly in normally developed babies whose mothers have had pregnancies uncomplicated by major pre-existing or arising conditions, thus offering real potential for prevention. This is a retrospective cohort study of all at- or near-term births across Australia (1997-2015) including 7,200 stillbirths among 4.9 million births at an estimated rate of 1.47 stillbirths per 1000 live births. The aim of this study is to develop a risk prediction model for late-gestation stillbirth by week of gestation for an Australian population.

  • Drivers of stillbirth in refugee women in Victoria

    Study Team: Miranda Davies-Tuck, Kirsten Palmer, Tanya Farrell, Ben Mol, Mary-Ann Davey and Euan Wallace

     

    This project aims to:

    1. Determine the timing and causes of stillbirth among refugee women in Victoria between 2012 and 2018 using the Victorian Perinatal Data collection and CCOPPMM database.
    2. Determine contributing factors to perinatal deaths in refugee women in Victoria using the CCOPPMM database.
    3. Determine disparities in access to and provision of care for migrant women in Victoria using medical records of African born women giving birth at the Monash Health.

    Combined these projects will provide evidence for efficacy of clinical practice change to prevent stillbirth by comparing stillbirth rates at sites that have not implemented practice change.  The study will also quantify if increased awareness regarding in the relationship between maternal ethnicity and stillbirth has already resulted in practice change by looking at rates of interventions for South Asian born women at non-Monash health sites.  The contribution of practice change relating to reduced fetal movements and detection of fetal growth restriction to the decreasing stillbirth rate in South Asian women in Victoria will also be determined. Given changes and increases in migration to Victoria this project will also identify other maternal country of birth groups in Victoria at higher risk of stillbirth. These projects will identify drivers of stillbirth in African born women in Victoria. It will also identify how best to provide care to prevent stillbirth in African born women through qualitative surveys.

  • Is area-based socio-economic deprivation associated with stillbirth in Queensland, Australia? A retrospective population-based study, 1994-2011

    Study Team: Susannah Leisher, Vicki Flenady, Ibielebe Ibinabo

     

    About 2.7 million babies are stillborn every year. While 98% occur in low- and middle-income countries, in high income countries huge disparity exists for disadvantaged women. The primary objective of this study was to examine the association between area-based socio-economic deprivation and stillbirth risk in the routine birth data set between July 1994 and December 2011 in the Queensland, Australia. Secondary objectives were to explore changes over time, and association between deprivation and both cause-specific and gestational age-specific stillbirth.

  • Stillbirth and Zika; A systematic review

    Study Team: Susannah Leisher, Stephen Morse, Louise Kuhn, Vicki Flenady, Arin Balalian, Hanna Reinebrant, Stephanie Shiau


    Background: In 2015, there were 2.6 million stillbirths, accounting for 4.4% of all global deaths. Despite this burden, global attention to stillbirths has been limited. Evidence has accumulated that Zika virus infection causes multiple adverse outcomes, possibly including fetal demise (stillbirths, miscarriages, abortions), but there has been limited reporting and analysis of these outcomes. We aimed to summarize available data on the fetal demise burden of Zika-affected pregnancies.

    Methods: This was a quasi-systematic review (PubMed, Embase, Web of Science; no language limits). Proportions of fetal demise of completed Zika-affected pregnancies were calculated. RRs for fetal demise among completed, Zika-affected versus uninfected pregnancies were estimated from cohort data.

    Results: Seventeen reports included 19,928 pregnant women or infants/fetuses with confirmed, probable or suspected Zika infection. Pregnancy outcomes that included fetal demise were known for 23% (4,492). There were 244 cases of fetal demise (5%). 20% of confirmed as compared to 7% of suspected Zika-affected pregnancies ended in fetal demise. Only one cohort study included asymptomatic as well as symptomatic mothers; the crude risk of fetal demise was nearly 13 times higher for Zika-affected as unaffected mothers (RR 12.76, 95% CI 3.94, 41.37, p-value <0.0001), as compared to a crude RR of microcephaly of 6.63 (95% CI 0.78, 57.83, p-value 0.07). Most studies included only symptomatic pregnant women or infants/fetuses with Zika-related anomalies; misclassification of infection status was possible.

    Conclusions: Available data on fetal demise associated with Zika virus infection is limited, especially in comparison to other outcomes such as microcephaly, yet there is evidence that fetal demise may be a significant burden of Zika virus infection. Studies of Zika infection outcomes should report on fetal demise.

  • Systematic review to identify risk factors for stillbirth.

    Study Team: Philippa Middleton, Michael Coory, Maria Makrides, David Ellwood, Vicki Flenady, Anneka Bowman (PhD)

     

    This high-quality systematic review and meta-analysis, to identify lifestyle, environmental and social risk factors of stillbirth in high-income counties, will update Flenady et al.’s 2011 Lancet publication.

  • The impact of regional M and M meetings, and drivers of reduced perinatal mortality in regional Victorian health services.

    Study Team: Miranda Davies – Tuck, Bree Bulle, Tanya Farrell, Kirsten Palmer

     

    This study aims to describe trends in perinatal death and causes of  in regional Victoria. It will identify changing demographic and obstetric interventions, and will assess the impact of the introduction of regional M and M meeting to reduce perinatal mortality in regional Victoria.

    Specifically, the project aims to:

    1. Determine rates of perinatal mortality and morbidity in regional Victorian health services between 2000 and 2019.
    2. Determine changes in demographics, transfers and obstetric interventions in regional Victorian health services between 2000 and 2018
    3. Compare 1 and 2 between regional services engaged in the M and M process to those who did not participate and with metropolitan health services over the study period.
    4. To quantify if the introduction of regional M and M have impacted perinatal mortality in Victorian regional services and drivers of any change.
  • Prediction of Fetal Growth Restriction: Individual Participant Data (IPD) Meta-Analysis With Decision Curve Analysis

    Study Team: Shakila, Thankgaratinam, John Allotey, Javier Zamora, Julie Dodds, Asma Khalil, Basky Thilaganathan, Richard Riley, Kym Snell, Gordon Smith, Lucy Chappell, Jenny Myers, Kate Morris, Aris Papageorghiou, Sanne Gordijn, Wessel Ganzevoort, Devane Declan, Ben Mol, Vicki Flenady, Lisa Askie, Ana Pilar Betrán Lazaga, Sarah Fisher

  • Induction of labour at or beyond 37 weeks' gestation

    Study Team: Philippa Middleton, Emily Shepherd, Johnathan Morris, Caroline A Crowther, Judith C Gomersall

    The objective of this study was to assess the effects of a policy of labour induction at or beyond 37 weeks' gestation compared with a policy of awaiting spontaneous labour indefinitely (or until a later gestational age, or until a maternal or fetal indication for induction of labour arises) on pregnancy outcomes for the infant and the mother.

    Read the review here.