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Background The Australian Safer Baby Bundle (SBB) consists of five elements (smoking cessation, fetal growth restriction, decreased fetal movements, maternal side sleeping and decision making around timing of birth) which aim to reduce stillbirth and improve antenatal care. Queensland (QLD), New South Wales (NSW), and Victoria (VIC) were the first states to implement the SBB, laying the foundation for its national rollout. This study explores site leads’ experiences integrating the SBB into routine care. Methods A mixed-methods study was conducted using surveys and interviews with site leads following SBB implementation across maternity services in QLD, NSW and VIC. Quantitative data were analysed descriptively, qualitative data underwent inductive and deductive thematic analysis, guided by Normalisation Process Theory (NPT) to identify implementation barriers and enablers. Results In 2022, 45 site leads completed surveys, and 20 were interviewed. From surveys, most reported strong endorsement of the SBB from hospital leadership (81%) and opinion leaders (73%). However, only 32% felt their service was adequately resourced, and just 17% believed teams had enough time for Quality Improvement (QI) activities. Only two of five SBB elements, decreased fetal movements (93%) and maternal side sleeping (82%), were reliably implemented across sites. Other elements showed moderate uptake, with smoking cessation (47%) achieving the lowest fidelity. From interviews, five themes were identified as barriers and enablers to implementing and sustaining the SBB in routine practice: (1) nationally consistent resources and training; (2) navigating QI readiness and capacity; (3) collaborative change; (4) service capacity to make recommendations operational; and (5) capability to access data and track progress. Mapping to the four NPT constructs revealed key drivers of SBB implementation: coherence (understanding the approach), cognitive participation (engagement), collective action (operationalising change through relationships) and reflexive monitoring (assessing and adapting). Conclusions SBB implementation was supported by strong leadership endorsement but challenged by limited resources, time for QI, and the exacerbating effects of the COVID-19 pandemic. Reliable integration of key elements varied across sites, shaped by consistent training, service capacity, collaborative approaches, and access to data. These findings underscore the need for tailored support and resilient infrastructure to embed and sustain evidence-based antenatal care practices at scale. Trial registration The Safer Baby Bundle Study was retrospectively registered on the Australian New Zealand Clinical Trials Registry database, ACTRN12619001777189, date assigned 16/12/2019.

IntroductionStillbirth continues to be a public health concern in high-income countries, and with mixed results from several stillbirth prevention interventions worldwide the need for an effective prevention method is ever present. The Safer Baby Bundle (SBB) proposes five evidence-based care packages shown to reduce stillbirth when implemented individually, and therefore are anticipated to produce significantly better outcomes if grouped together. This protocol describes the planned economic evaluation of the SBB quality improvement initiative in Australia.Methods and analysisThe implementation of the SBB will occur over three state-based health jurisdictions in Australia—New South Wales, Queensland and Victoria, from July 2019 onwards. The intervention is being applied at the state level, with sites opting to participate or not, and no individual woman recruitment. The economic evaluation will be based on a whole-of-population linked administrative dataset, which will include the data of all mothers, and their resultant children, who gave birth between 1 January 2016 and 31 December 2023 in these states, covering the preimplementation and postimplementation time period. The primary health outcome for this economic evaluation is late gestation stillbirths, with the secondary outcomes including but not limited to neonatal death, gestation at birth, mode of birth, admission to special care nursery and neonatal intensive care unit, and physical and mental health conditions for mother and child. Costs associated with all healthcare use from birth to 5 years post partum will be included for all women and children. A cost-effectiveness analysis will be undertaken using a difference-in-difference analysis approach to compare the primary outcome (late gestation stillbirth) and total costs for women before and after the implementation of the bundle.Ethics and disseminationEthics approval for the SBB project was provided by the Royal Brisbane & Women’s Hospital Human Research Ethics Committee (approval number: HREC/2019/QRBW/47709). Approval for the extraction of data to be used for the economic evaluation was granted by the New South Wales Population and Health Services Research Ethics Committee (approval number: 2020/ETH00684/2020.11), Australian Institute of Health and Welfare Human Research Ethics Committee (approval number: EO2020/4/1167), and Public Health Approval (approval number: PHA 20.00684) was also granted. Dissemination will occur via publication in peer reviewed journals, presentation at clinical and policy-focused conferences and meetings, and through the authors’ clinical and policy networks.This study will provide evidence around the cost effectiveness of a quality improvement initiative to prevent stillbirth, identifying the impact on health service use during pregnancy and long-term health service use of children.

IntroductionGiven the increasing attention to reduce stillbirth rates in migrant women and variable clinical guidance, we quantified contemporary trends in stillbirth based on maternal region of birth.MethodsPopulation-based study of singleton births ≥20 weeks of gestation between 2012 and 2019 from the Victorian Perinatal Data Collection (N=571 998). We investigated the association between maternal self-reported region of birth and stillbirth overall using logistic regression, and gestation and timing of stillbirth using multinomial regression. Trends in stillbirth overall, iatrogenic births, admission to a neonatal intensive care unit or special care nursery, neonatal death and cause of stillbirth by region of birth were also investigated.ResultsRates of stillbirth were significantly higher in women born in Africa (adjusted OR (aOR) 1.76: 1.47 to 2.12) and South Asia (aOR 1.26: 1.11 to 1.43) when compared with locally born non-Indigenous women. For women born in Africa, this was irrespective of gestation, while for women born in South Asia, this was specific to preterm stillbirths. Overall, we observed a decreasing trend in stillbirth among women born in Australia, while the stillbirth rate remained consistently higher and did not significantly decrease in women born in Africa, Oceania, New Zealand and South Asia. Over the same period, iatrogenic births significantly increased. Causes of stillbirth also differed by maternal region of birth.ConclusionsWhile we observed some improvements in stillbirth rates and increasing rates of iatrogenic birth, maternal region of birth remains an independent risk factor for stillbirth requiring targeted approaches.

Background Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women’s satisfaction with care across the maternity continuum. Methods Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating. Results Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88 % in the caseload group and 74 % in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95 % CI 2.79, 4.03), intrapartum care (OR 2.14; 95 % CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95 % CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95 % CI 2.64, 3.85). Conclusion For women at low risk of medical complications, caseload midwifery increases women’s satisfaction with antenatal, intrapartum and postpartum care. Trial registration Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007).

ObjectivesTo determine whether sharing of routinely collected health service performance data could have predicted a critical safety failure at an Australian maternity service.DesignObservational quantitative descriptive study.SettingA public hospital maternity service in Victoria, Australia.Data sourcesA public health service; the Victorian state health quality and safety office—Safer Care Victoria; the Health Complaints Commission; Victorian Managed Insurance Authority; Consultative Council on Obstetric and Paediatric Mortality and Morbidity; Paediatric Infant Perinatal Emergency Retrieval; Australian Health Practitioner Regulation Agency.Main outcome measuresNumbers and rates for events (activity, deaths, complaints, litigation, practitioner notifications). Correlation coefficients.ResultsBetween 2000 and 2014 annual birth numbers at the index hospital more than doubled with no change in bed capacity, to be significantly busier than similar services as determined using an independent samples t-test (p<0.001). There were 36 newborn deaths, 11 of which were considered avoidable. Pearson correlations revealed a weak but significant relationship between number of births per birth suite room birth and perinatal mortality (r2 =0.18, p=0.003). Independent samples t-tests demonstrated that the rates of emergency neonatal and perinatal transfer were both significantly lower than similar services (both p<0.001). Direct-to-service patient complaints increased ahead of recognised excess perinatal mortality.ConclusionWhile clinical activity data and direct-to-service patient complaints appear to offer promise as potential predictors of health service stress, complaints to regulators and medicolegal activity are less promising as predictors of system failure. Significant changes to how all data are handled would be required to progress such an approach to predicting health service failure.

Background Postnatal care in hospital is often provided using defined care pathways, with limited opportunity for more refined and individualised care. We explored whether a tertiary maternity service could provide flexible, individualised early postnatal care for women in a dynamic and timely manner, and if this approach was acceptable to women. Methods A feasibility study was designed to inform a future randomised controlled trial to evaluate an alternative approach to postnatal care. English-speaking women at low risk of medical complications were recruited around 26 weeks gestation to explore their willingness to participate in a study of a new, flexible model of care that involved antenatal planning for early postpartum discharge with additional home-based postnatal care. The earlier women were discharged from hospital, the more home-based visits they were eligible to receive. Program uptake was measured, women’s views obtained by a postal survey sent at eight weeks postpartum and clinical data collected from medical records. Results Study uptake was 39% (109/277 approached). Most women (n=103) completed a postnatal care plan during pregnancy; 17% planned to leave hospital within 12 hours of giving birth and 36% planned to stay 48 hours. At eight weeks postpartum most women (90%) were positive about the concept and 88% would opt for the same program again. Of the 28% who stayed in hospital for the length they had planned, less than half (43%) received the appropriate number of home visits, and only 41% were given an option for the timing of the visit. Most (62%) stayed in hospital longer than planned (probably due to clinical complications); 11% stayed shorter than planned. Conclusions Women were very positive about individualised postnatal care planning that commenced during pregnancy. Given the hospital stay may be impacted by clinical factors, individualised care planning needs to continue into the postnatal period to take into account circumstances which cannot be planned for during pregnancy. However, individualised care planning during the postnatal period which incorporates a high level of flexibility may be challenging for organisations to manage and implement, and a randomised controlled trial of such an approach may not be feasible.

There is debate about whether diastolic blood pressure should be recorded as the fourth (muffling, K4) or fifth (disappearance, K5) Korotkoff sound in pregnancy. We compared maternal and fetal outcomes and the likelihood that episodes of severe hypertension would be recorded when hypertensive pregnancies were managed according to either K4 or K5. 220 pregnant women with diastolic hypertension (K4 ≥90 mm Hg) after the 20th week of gestation were enrolled in a prospective randomised study at two obstetric units in Australia; they were randomly assigned management with K4 (n=103) or K5 (n=117) for the remainder of the pregnancy. Clinical management was according to a uniform department protocol. Analysis was by intention to treat. All the women completed the trial. An episode of severe hypertension (systolic ≥170 mm Hg, diastolic ≥110 mm Hg, or both) was more likely to be recorded with use of K4 than with use of K5 (39 [38%] VS 30 [26%] women, p=0·051), mainly because of a greater likelihood that severe diastolic hypertension would be recorded (34 [33%] VS 20 [17%], p=0·006). The frequency of severe systolic hypertension and simultaneous severe systolic and diastolic hypertension did not differ between groups. Pregnancy was prolonged by an average of 2 weeks in both groups, and there were no significant differences between the groups in laboratory data, requirements for antihypertensive treatment, birthweight, fetal growth retardation, or perinatal mortality. There was no eclampsia or significant maternal morbidity in either group. A change from use of K4 to K5 would mean that one fewer case of severe diastolic hypertension would be recorded for every six hypertensive pregnancies, but all other episodes of severe hypertension would be recorded with similar frequency. Since the K4/ K5 difference is smaller in hypertensive than in normotensive pregnant women and since K5 is closer to the actual intra-arterial pressure and more reliably detected, universal adoption of K5 to record diastolic blood pressure in hypertensive pregnancy should be considered.

Background No consensus exists on whether flat epithelial atypia (FEA) diagnosed percutaneously should be surgically excised. A systematic review and meta-analysis of the frequency of upgrade to cancer or an atypical ductal hyperplasia (ADH) at surgical excision of FEA was performed. Methods Embase, MEDLINE, Scopus, and Web of Science databases from January 2003 to November 2015 were searched. The inclusion criteria required a manuscript in English with original data on FEA diagnosed percutaneously, data including the presence or absence of other concurrent high-risk lesions, and data including outcome of cancer at surgical excision. Studies were assessed for quality, and two reviewers extracted data. Random-effects meta-analysis was used to pool estimates. The impact of study-level characteristics was assessed by stratified meta-analysis and meta-regression. Results The inclusion criteria was met by 32 studies. A total of 1966 core needle biopsies showed pure FEA, and 1517 (77%) showed surgical excision. The proportions of patients with upgrade to cancer varied from 0 to 42%, with an overall pooled estimate of 11.1%. Heterogeneity was observed, with the greatest impact based on whether a study included cases of FEA diagnosed before 2003. With restriction of the investigation to 16 higher-quality studies, the cancer upgrade pooled estimate was 7.5% (95% confidence interval [CI], 5.4–10.4%), and the rate of invasive cancer was 3% (95% CI 1.9–4.5%). For upgrade to ADH, data from 22 studies including 937 patients were analyzed. The proportion of patients upgraded to ADH ranged from 0 to 60%, with a pooled estimate of 17.9% overall and 18.6% among high-quality studies. Conclusions With patient management change potential for approximately 25% of patients, this analysis supports a general recommendation for surgical excision of FEA diagnosed by core biopsy.

Pain and depression are interrelated, and worse postpartum pain has been associated with postpartum depression. It remains unclear whether improved pain and mood after delivery can also improve maternal parenting. Few studies have examined relationships between postpartum pain and negative mood (anxiety or depression) or their effects on parent–infant relationship outcomes. The purpose of this study was to explore the relationships between postpartum pain, mood, parent–infant attachment, parenting self-efficacy, and infant development. This was a prospective longitudinal observational pilot study of nulliparous women enrolled at the third trimester and presenting for labor and delivery at term gestation. Baseline third trimester assessments included validated inventories of pain (the brief pain inventory, BPI), depression (the Edinburgh postnatal depression screen, EPDS), anxiety (the state trait anxiety inventory, STAI), multidimensional scale of perceived social support (perceived social support scale, MSPSS) and perceived stress scale (PSS). Demographic and labor characteristics were recorded. At 6 weeks and 3 months postpartum, self-reported assessments included EPDS, STAI, BPI, maternal parent infant attachment scale (MPAS), and perceived maternal parenting self-efficacy (PMP-SE). Child development outcomes were assessed at 6 weeks and 3 months using the Ages and Stages Questionnaire (ASQ). Univariable linear regression assessed the relationships between pain and parenting outcomes (MPAS and PMP-SE), including potential interactions between pain and mood for parenting outcomes. Generalized linear modeling was used to explore the relationships between postpartum pain, parenting outcomes, and child development outcomes. Of 187 subjects, 87 had complete data on parent–infant attachment and parenting self-efficacy data at 3 months. Lower \"pain right now\" scores (BPI) on postpartum day 1 was associated with higher maternal–infant attachment (MPAS) at 6 weeks postpartum (Estimate − 1.8, 95% CI − 3.4 to − 0.2, P  < 0.03) but not at 3 months (Estimate 0.23 95% CI − 1.1 to 1.6, P  = 0.7). Higher depression (EPDS) scores at 6 weeks were also associated with lower MPAS scores at 6 weeks (Estimate − 1.24, 95% CI − 2.07 to − 0.40, P  = 0.004). However, there was no evidence that the relationship between pain and MPAS varied by depression score at 6 weeks ( P  = 0.42). Pain scores at baseline, six weeks, or three months did not correlate with parenting outcomes (MPAS, PMP-SE) at six weeks or three months. Results of the generalized linear modeling revealed relationships between pain, age, anxiety (STAI), and depression (EPDS) predictors, and the outcomes of parenting (MPAS, PMP-SE) and gross motor and personal–social (ASQ) aspects of infant development. There is a pattern of association between worse postpartum pain, anxiety, and depression with worse parenting outcomes. Depression and pain may also affect infant development, but future work is required to replicate and characterize these potential relationships.