The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications.

BACKGROUND AND OBJECTIVE: Medication use is increasing to treat both pre-existing and pregnancy-related medical conditions or complications. This study aims to investigate factors associated with multiple medication use during pregnancy, as well as any increased risk of pregnancy complications for women taking multiple medications. METHODS: A retrospective analysis of routinely collected medical records of singleton pregnant women was conducted in Southeast Melbourne, Australia, between 2016 and 2021. Self-reported medication use was recorded as part of routine medical care, starting from the first antenatal booking appointment and continuing for every subsequent antenatal appointment until birth. Multimorbidity was defined as having two or more medical conditions. Logistic regression was used to assess factors influencing multiple medication use (defined as taking two or more non-supplemental medications at any stage of pregnancy) and associations with pregnancy complications. RESULTS: Of 48,502 participants, 34.9% used one medication, while 11.7% used multiple medications. Women of older age (30-34, 35-39, and ≥  40 years), higher body mass index (25.0-29.9 kg/m2 and ≥  30 kg/m2), born in Australasia and Oceania, higher socioeconomic status, and multimorbidity were more likely to use multiple medications during pregnancy. Women taking multiple medications had a higher risk of preterm and caesarean deliveries, fetal death, and neonatal admissions to intensive care. Sensitivity analyses exploring different morbidity categories produced no changes to findings. CONCLUSIONS: Medication use during pregnancy is prevalent, with many pregnant mothers taking multiple medications. Given the rising maternal age, body mass index, and morbidities in pregnancy, the use of medications during pregnancy is increasing. Such use correlates with an increased chance of adverse pregnancy outcomes. In the context of limited trials on the safety and efficacy of medications in pregnancy, timely harnessing of the information available within routine medical records for post-marketing surveillance is important.

The iSEARCH randomised controlled trial protocol: a pragmatic Australian phase III clinical trial of intrapartum sildenafil citrate to improve outcomes potentially related to intrapartum hypoxia.

INTRODUCTION: We showed in a phase II randomised controlled trial (RCT) that oral sildenafil citrate in term labour halved operative birth for fetal distress. We outline the protocol for a phase III RCT (can intrapartum SildEnafil safely Avert the Risks of Contraction-induced Hypoxia? (iSEARCH)) of 3200 women in Australia to assess if sildenafil citrate reduces adverse perinatal outcomes related to intrapartum hypoxia. METHODS AND ANALYSIS: iSEARCH will enrol 3200 Australian women in term labour to determine whether up to three 50 mg oral doses of sildenafil citrate versus placebo reduce the relative risk of a primary composite end point of 10 perinatal outcomes potentially related to intrapartum hypoxia by 35% (from 7% to 4.55%). Secondary aims are to evaluate reductions in the relative risk of emergency caesarean section or instrumental vaginal birth for fetal distress by 25% (from 20% to 15%) and in healthcare costs. To detect a 35% reduction in the primary outcome for an alpha of 0.05 and power of 80% with 10% dropout in each arm requires 3200 women (1600 in each arm). This sample size will also yield >90% power to detect a 25% reduction for the secondary outcome of any operative birth (caesarean section or instrumental vaginal birth) for fetal distress. ETHICS AND DISSEMINATION: Ethical approval for the iSEARCH RCT was granted by the Hunter New England Human Research Ethics Committee (ref no: 2020/ETH02791). Results will be disseminated through websites, peer-reviewed publications, scientific meetings and social media, news outlets, television and radio. TRIAL REGISTRATION NUMBER: ACTRN12621000231842.

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain.

INTRODUCTION: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

Learning together for better health using an evidence-based Learning Health System framework: a case study in stroke.

BACKGROUND: In the context of expanding digital health tools, the health system is ready for Learning Health System (LHS) models. These models, with proper governance and stakeholder engagement, enable the integration of digital infrastructure to provide feedback to all relevant parties including clinicians and consumers on performance against best practice standards, as well as fostering innovation and aligning healthcare with patient needs. The LHS literature primarily includes opinion or consensus-based frameworks and lacks validation or evidence of benefit. Our aim was to outline a rigorously codesigned, evidence-based LHS framework and present a national case study of an LHS-aligned national stroke program that has delivered clinical benefit. MAIN TEXT: Current core components of a LHS involve capturing evidence from communities and stakeholders (quadrant 1), integrating evidence from research findings (quadrant 2), leveraging evidence from data and practice (quadrant 3), and generating evidence from implementation (quadrant 4) for iterative system-level improvement. The Australian Stroke program was selected as the case study as it provides an exemplar of how an iterative LHS works in practice at a national level encompassing and integrating evidence from all four LHS quadrants. Using this case study, we demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare improvement. We emphasize the transition from research as an endpoint, to research as an enabler and a solution for impact in healthcare improvement. CONCLUSIONS: The Australian Stroke program has nationally improved stroke care since 2007, showcasing the value of integrated LHS-aligned approaches for tangible impact on outcomes. This LHS case study is a practical example for other health conditions and settings to follow suit.

Reducing intravenous antibiotics in neonates born ≥35 weeks' gestation: A quality improvement study.

AIM: To assess the impact of the Early Onset Sepsis (EOS) calculator, implemented as a quality improvement study, to reduce the rate of unnecessary antibiotics in neonates born ≥35 weeks' gestation. METHODS: An audit of routinely collected hospital data from January 2008 to March 2014 (retrospective) and from January 2018 to September 2019 (prospective) determined baseline incidence of EOS intravenous antibiotic use in neonates born ≥35 weeks' gestation in a tertiary level perinatal centre. Plan-do-study-act (PDSA) cycles were applied to implement the EOS calculator. Statistical process control methodology and time series analysis assessments were used to assess the potential impact of the PDSA cycles on the rate of intravenous antibiotics, blood culture collection, EOS, length of stay and health care costs (not adjusted for potential confounders). RESULTS: In the study population, from January 2008 to March 2014, the baseline incidence of intravenous antibiotic use was 10.49% (2970/28290), whilst only 0.067% (19/28290) neonates had culture proven EOS. From January 2018 to October 2019, prior to implementation of the EOS calculator, 13.3% (1119/8411) neonates were treated with intravenous antibiotic and the use decreased to 8.3% (61/734) post-implementation. The rate of blood culture collection decreased from 14.4% (1211/8411) to 11.9% (87/734). There were no cases of missed EOS. Length of stay decreased from 2.68 to 2.39 days, with an estimated cost saving of $366 per patient per admission. CONCLUSION: Implementing the EOS calculator in a tertiary hospital setting reduced invasive investigations for EOS and intravenous antibiotic use among neonates ≥35 weeks' gestation. This can result in reduced length of neonatal hospital stays, and associated health care cost savings and may reduce separation of mother and baby.

Preventing postnatal depression in new mothers using telephone peer support: protocol for the DAISY (Depression and AnxIety peer Support studY) multi-centre randomised controlled trial.

INTRODUCTION: Postnatal depression affects up to one in six new mothers in Australia each year, with significant impacts on the woman and her family. Prevention strategies can be complicated by a woman's reluctance to seek professional help. Peer support is a promising but inadequately tested early intervention. Very few trials have reported on the efficacy of peer support in the perinatal period and no study has been undertaken in Australia. We will explore if proactive telephone-based peer (mother-to-mother) support, provided to women identified as being at high risk of postnatal depression, impacts on clinically significant depressive symptomatology at 6 months postpartum. METHODS AND ANALYSIS: This is a protocol for a single-blinded, multi-centre, randomised controlled trial conducted in Melbourne, Australia. Eligible women will be recruited from either the postnatal units of two maternity hospitals, or around 4 weeks postpartum at maternal and child health centres within two metropolitan council areas. A total of 1060 (530/group) women will be recruited and randomly allocated (1:1 ratio) to either-usual care, to receive the standard community postpartum services available to them, or the intervention group, to receive proactive telephone-based support from a peer volunteer for 6 months, in addition to standard community services. PRIMARY OUTCOME: clinically significant depressive symptomatology at 6 months postpartum as measured using the Edinburgh Postnatal Depression Scale. SECONDARY OUTCOMES: symptoms of anxiety and/or stress, health-related quality of life, loneliness, perception of partner support, self-rated parenting, child health and development, infant feeding and health service use. The cost-effectiveness of the intervention relative to standard care will also be assessed. ETHICS AND DISSEMINATION: Ethics approval has been obtained from La Trobe University, St. Vincent's Hospital, the Royal Women's Hospital, Northern Health, Victorian Department of Health and Human Services and Victorian Department of Education and Training. Written informed consent will be obtained from all participants before randomisation. Trial results will be disseminated through peer-reviewed publications, conference presentations and a higher degree thesis. TRIAL REGISTRATION NUMBER: ACTRN12619000684123; Australian New Zealand Clinical Trials Registry.

A cost analysis of upscaling access to continuity of midwifery carer: Population-based microsimulation in Queensland, Australia.

OBJECTIVE: To quantify the economic impact of upscaling access to continuity of midwifery carer, compared with current standard maternity care, from the perspective of the public health care system. METHODS: We created a static microsimulation model based on a whole-of-population linked administrative data set containing all public hospital births in one Australian state (Queensland) between July 2017 to June 2018 (n = 37,701). This model was weighted to represent projected State-level births between July 2023 and June 2031. Woman and infant health service costs (inpatient, outpatient and emergency department) during pregnancy and birth were summed. The base model represented current standard maternity care and a counterfactual model represented two hypothetical scenarios where 50 % or 65 % of women giving birth would access continuity of midwifery carer. Costs were reported in 2021/22 AUD. RESULTS: The estimated cost savings to Queensland public hospital funders per pregnancy were $336 in 2023/24 and $546 with 50 % access. With 65 % access, the cost savings were estimated to be $534 per pregnancy in 2023/24 and $839 in 2030/31. A total State-level annual cost saving of $12 million in 2023/24 and $19 million in 2030/31 was estimated with 50 % access. With 65 % access, total State-level annual cost savings were estimated to be $19 million in 2023/24 and $30 million in 2030/31. CONCLUSION: Enabling most childbearing women in Australia to access continuity of midwifery carer would realise significant cost savings for the public health care system by reducing the rate of operative birth.

Significant healthcare resource utilisation in the management of skin and soft tissue infections in the Torres Strait, Australia.

INTRODUCTION: Aboriginal and Torres Strait Islander Peoples (First Nations Australians) living in remote communities are hospitalised with skin and soft tissue infections (SSTIs) at three times the rate of non-First Nations Australians. The Torres Strait in tropical northern Australia has a highly dispersed population mainly comprising First Nations Australians. This study aimed to define the health service utilisation and health system costs associated with SSTIs in the Torres Strait and to improve the quality of regional healthcare delivery. METHODS: The research team conducted a retrospective, de-identified audit of health records for a 2-year period, 2018-2019. The aim was to define health service utilisation, episodes of outpatient care, emergency department care, inpatient care and aeromedical retrieval services for SSTIs. RESULTS: Across 2018 - 2019, there were 3509 outpatient episodes of care for SSTIs as well as 507 emergency department visits and 100 hospitalisations. For individuals with an SSTI, the mean outpatient clinic episode cost $240; the mean emergency department episode cost $400.85, the mean inpatient episode cost $8403.05 while an aeromedical retrieval service cost $18,670. The total costs to the health system for all services accessed for SSTI management was $6,169,881 per year, 3% of the total annual health service budget. CONCLUSION: Healthcare costs associated with SSTIs in the Torres Strait are substantial. The implementation of effective preventative and primary care interventions may enable resources to be reallocated to address other health priorities in the Torres Strait.

Economic evaluations of assisted reproductive technologies in high-income countries: a systematic review.

STUDY QUESTION: Which assited reproductive technology (ART) interventions in high-income countries are cost-effective and which are not? SUMMARY ANSWER: Among all ART interventions assessed in economic evaluations, most high-cost interventions, including preimplantation genetic testing for aneuploidy (PGT-A) for a general population and ICSI for unexplained infertility, are unlikely to be cost-effective owing to minimal or no increase in effectiveness. WHAT IS KNOWN ALREADY: Approaches to reduce costs in order to increase access have been identified as a research priority for future infertility research. There has been an increasing number of ART interventions implemented in routine clinical practice globally, before robust assessments of evidence on economic evaluations. The extent of clinical effectiveness of some studied comparisons has been evaluated in high-quality research, allowing more informative decision making around cost-effectiveness. STUDY DESIGN, SIZE, DURATION: We performed a systematic review and searched seven databases (MEDLINE, PUBMED, EMBASE, COCHRANE, ECONLIT, SCOPUS, and CINAHL) for studies examining ART interventions for infertility together with an economic evaluation component (cost-effectiveness, cost-benefit, cost-utility, or cost-minimization assessment), in high-income countries, published since January 2011. The last search was 22 June 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS: Two independent reviewers assessed publications and included those fulfilling the eligibility criteria. Studies were examined to assess the cost-effectiveness of the studied intervention, as well as the reporting quality of the study. The chosen outcome measure and payer perspective were also noted. Completeness of reporting was assessed against the Consolidated Health Economic Evaluation Reporting Standard. Results are presented and summarized based on the intervention studied. MAIN RESULTS AND THE ROLE OF CHANCE: The review included 40 studies which were conducted in 11 high-income countries. Most studies (n = 34) included a cost-effectiveness analysis. ART interventions included medication or strategies for controlled ovarian stimulation (n = 15), IVF (n = 9), PGT-A (n = 7), single embryo transfer (n = 5), ICSI (n = 3), and freeze-all embryo transfer (n = 1). Live birth was the mostly commonly reported primary outcome (n = 27), and quality-adjusted life years was reported in three studies. The health funder perspective was used in 85% (n = 34) of studies. None of the included studies measured patient preference for treatment. It remains uncertain whether PGT-A improves pregnancy rates compared to IVF cycles managed without PGT-A, and therefore cost-effectiveness could not be demonstrated for this intervention. Similarly, ICSI in non-male factor infertility appears not to be clinically effective compared to standard fertilization in an IVF cycle and is therefore not cost-effective. Interventions such as use of biosimilars or HMG for ovarian stimulation are cheaper but compromise clinical effectiveness. LIMITATIONS, REASONS FOR CAUTION: Lack of both preference-based and standardized outcomes limits the comparability of results across studies. The selection of efficacy evidence offered for some interventions for economic evaluations is not always based on high-quality randomized trials and systematic reviews. In addition, there is insufficient knowledge of the willingness to pay thresholds of individuals and state funders for treatment of infertility. There is variable quality of reporting scores, which might increase uncertainty around the cost-effectiveness results. WIDER IMPLICATIONS OF THE FINDINGS: Investment in strategies to help infertile people who utilize ART is justifiable at both personal and population levels. This systematic review may assist ART funders decide how to best invest to maximize the likelihood of delivery of a healthy child. STUDY FUNDING/COMPETING INTEREST(S): There was no funding for this study. E.C. and R.W. receive salary support from the National Health and Medical Research Council (NHMRC) through their fellowship scheme (EC GNT1159536, RW 2021/GNT2009767). M.D.-T. reports consulting fees from King Fahad Medical School. All other authors have no competing interests to declare. REGISTRATION NUMBER: Prospero CRD42021261537.

Midwife-led birthing centres in Bangladesh, Pakistan and Uganda: an economic evaluation of case study sites.

INTRODUCTION: Achieving the Sustainable Development Goals to reduce maternal and neonatal mortality rates will require the expansion and strengthening of quality maternal health services. Midwife-led birth centres (MLBCs) are an alternative to hospital-based care for low-risk pregnancies where the lead professional at the time of birth is a trained midwife. These have been used in many countries to improve birth outcomes. METHODS: The cost analysis used primary data collection from four MLBCs in Bangladesh, Pakistan and Uganda (n=12 MLBC sites). Modelled cost-effectiveness analysis was conducted to compare the incremental cost-effectiveness ratio (ICER), measured as incremental cost per disability-adjusted life-year (DALY) averted, of MLBCs to standard care in each country. Results were presented in 2022 US dollars. RESULTS: Cost per birth in MLBCs varied greatly within and between countries, from US$21 per birth at site 3, Bangladesh to US$2374 at site 2, Uganda. Midwife salary and facility operation costs were the primary drivers of costs in most MLBCs. Six of the 12 MLBCs produced better health outcomes at a lower cost (dominated) compared with standard care; and three produced better health outcomes at a higher cost compared with standard care, with ICERs ranging from US$571/DALY averted to US$55 942/DALY averted. CONCLUSION: MLBCs appear to be able to produce better health outcomes at lower cost or be highly cost-effective compared with standard care. Costs do vary across sites and settings, and so further exploration of costs and cost-effectiveness as a part of implementation and establishment activities should be a priority.

Long-Term Effect of Having a Child at Risk of Developmental Delays on Parental Labor Force Participation.

OBJECTIVE: This study aimed to examine the long-term influence of having a child at risk of different developmental delays (communication, mobility, self-care, relating, learning, coping, or behaving) on parental labor force participation as the child grows. METHOD: A retrospective cohort was conducted using data from the Longitudinal Study of Australian Children survey, Waves 1-8 covering birth to 15 years of age of children. Multivariable logistic regressions were used to explore the odds ratio of mothers being out of the labor force at different children's ages. Cox proportional hazards models were utilized to identify the 'risk' of mothers returning to the workforce after leaving. All models were adjusted for the mother's age, education attainment, and employment status at time of birth, as well as marital status at the current wave. RESULTS: There were 5,107 records of children, and 266 of them were at risk of any developmental delays at age 4-5 years. This sample represents 243, 026 children born in Australia in 2003/04. After adjusting for potential confounders, mothers of children at risk of each type of developmental delay (except mobility and self-care) had greater odds of being out of, and not returning to the labor force from children aged 2-3 to 14-15 years, when compared to mothers of children who are not at risk of developmental delays. Similar differences were found for fathers but were distinctly small and with narrower fluctuations, compared to mothers. CONCLUSION: Policies and programs funded by the government are greatly needed to support the mothers of children at risk of developmental delays.

How the structural determinants of health inequities impact access to prescription medication for pregnant women in Australia: a narrative review.

Structural factors that contribute to health disparities (e.g., population-level policies, cultural norms) impact the distribution of resources in society and can affect medication accessibility; even in high-income countries like Australia. Industry practices and regulatory approaches (e.g., a conservative approach to testing medicines in pregnant women) influence the availability of safety and efficacy data necessary for the licencing and funding of prescription medications used during pregnancy. Consequently, pregnant women may be prescribed medications outside of regulatory or funder-approved indications, posing risks for both prescribers and pregnant women and potentially compromising equitable access to medications. This review examines the regulatory and legislative structural factors that contribute to health disparities and perpetuate the deeply ingrained social norm that we should be protecting pregnant women from clinical research rather than safeguarding them through such research. Addressing these challenges requires a renewed commitment to integrated, woman-centred maternal healthcare and strengthened collaboration across all sectors. Funding: Australian Government Research Training Program Stipend from the University of Technology Sydney, National Health and Medical Research Council (NHMRC) Fellowship, Channel 7 Children's Research Foundation Fellowship (CRF-210323).

Likelihood of primary cesarean section following induction of labor in singleton cephalic pregnancies at term, compared with expectant management: An Australian population-based, historical cohort study.

INTRODUCTION: There has been increased use of both induction of labor (IOL) and cesarean section for women with term pregnancies in many high-income countries, and a trend toward birth at earlier gestational ages. Existing evidence regarding the association between IOL and cesarean section for term pregnancies is mixed and conflicting, and little evidence is available on the differential effect at each week of gestation, stratified by parity. MATERIAL AND METHODS: To explore the association between IOL and primary cesarean section for singleton cephalic pregnancies at term, compared with two definitions of expectant management (first: at or beyond the week of gestation at birth following IOL; and secondary: only beyond the week of gestation at birth following IOL), we performed analyses of population-based historical cohort data on women who gave birth in one Australian state (Queensland), between July 1, 2012 and June 30, 2018. Women who gave birth before 37+0 or after 41+6 weeks of gestation, had stillbirths, no-labor, multiple births (twins or triplets), non-cephalic presentation at birth, a previous cesarean section, or missing data on included variables were excluded. Four sub-datasets were created for each week at birth (37-40). Unadjusted relative risk, adjusted relative risk using modified Poisson regression, and their 95% confidence intervals were calculated in each sub-dataset. Analyses were stratified by parity (nulliparas vs. parous women with a previous vaginal birth). Sensitivity analyses were conducted by limiting to women with low-risk pregnancies. RESULTS: A total of 239 094 women were included in the analysis, 36.7% of whom gave birth following IOL. The likelihood of primary cesarean section following IOL in a Queensland population-based cohort was significantly higher at 38 and 39 weeks, compared with expectant management up to 41+6 weeks, for both nulliparas and paras with singleton cephalic pregnancies, regardless of risk status of pregnancy and definition of expectant management. No significant difference was found for nulliparas at 37 and 40 weeks; and for paras at 40 weeks. CONCLUSIONS: Future studies are suggested to investigate further the association between IOL and other maternal and neonatal outcomes at each week of gestation in different maternal populations, before making any recommendation.

The financial impact of offering publicly funded homebirths: A population-based microsimulation in Queensland, Australia.

BACKGROUND: Despite strong evidence of benefits and increasing consumer demand for homebirth, Australia has failed to effectively upscale it. To promote the adoption and expansion of homebirth in the public health care system, policymakers require quantifiable results to evaluate its economic value. To date, there has been limited evaluation of the financial impact of birth settings for women at low risk of pregnancy complications. OBJECTIVE: This study aimed to examine the difference in inpatient costs around birth between offering homebirth in the public maternity system versus not offering public homebirth to selected women who meet low-risk pregnancy criteria. METHODS: We used a whole-of-population linked administrative dataset containing all women who gave birth in Queensland (one Australian State) between 01/07/2012 and 30/06/2018 where publicly funded homebirth is not currently offered. We created a static microsimulation model to compare the inpatient cost difference for mother and baby around birth based on the women who gave birth between 01/07/2017 and 30/06/2018 (n = 36,314). The model comprised of a base model - representing standard public hospital care, and a counterfactual model - representing a hypothetical scenario where 5 % of women who gave birth in public hospitals planned to give birth at home prior to the onset of labour (n = 1816). Costs were reported in 2021/22 AUD. RESULTS: In our hypothetical scenario, after considering the effect of assumptive place and mode of birth for these planned homebirths, the estimated State-level inpatient cost saving around birth (summed for mother and babies) per pregnancy were: AU$303.13 (to Queensland public hospitals) and AU$186.94 (to Queensland public hospital funders). This calculates to a total cost saving per annum of AU$11 million (to Queensland public hospitals) and AU$6.8 million (to Queensland public hospital funders). CONCLUSION: A considerable amount of inpatient health care costs around birth could be saved if 5 % of women booked at their local public hospitals, planned to give birth at home through a public-funded homebirth program. This finding supports the establishment and expansion of the homebirth option in the public health care system.

Intrapartum use of sildenafil citrate to prevent fetal compromise and emergency operative birth in term pregnancies in the United Kingdom and Australia: A preliminary cost-effectiveness analysis.

OBJECTIVE: To compare cost-effectiveness of oral sildenafil citrate, administered after onset of labor, with standard care to health system funders in the UK and Australia. METHODS: We conducted a modeled cost-effectiveness analysis, measuring costs and quality adjusted life years (QALYs), using a decision-analytic model covering onset of labor to 1 month post-birth. The relative risk of emergency cesarean section and operative vaginal birth was taken from a Phase 2 placebo controlled double blinded randomized control trial. RESULTS: Both options of care resulted in the same QALYs gained over the model time period (0.08). Sildenafil citrate was cost-saving compared with standard care, saving £92 per birth in the UK (AU$303 per birth in Australia). Sensitivity analyses did not identify any areas of uncertainty that stopped sildenafil citrate being cost saving compared with standard care. Threshold analysis revealed that sildenafil citrate would be cost saving up to a per birth drug or administration cost of £152.32 in the UK (AU$333.61 in Australia). CONCLUSION: Oral sildenafil citrate may be cost saving compared with standard care; however, the effects on neonatal outcomes still need to be demonstrated in large randomized trials.

Identifying Longer-Term Health Events and Outcomes and Health Service Use of Low Birthweight CALD Infants in Australia.

INTRODUCTION: Approximately one-third of all births in Australia each year are by culturally and linguistically diverse (CALD) women. CALD women are at an increased risk of adverse pregnancy and birth outcomes including prematurity and low birthweight. Infants born weighing less than 2500 g are susceptible to increased risk of ill health and morbidities such as cognitive defects including cerebral palsy, and neuro-motor functioning. METHODS: An existing linked administrative dataset, Maternity 1000 was utilized for this study which has identified all children born in Queensland (QLD), Australia, between 1st July 2012 to 30th June 2018 from the QLD Perinatal Data Collection. This has then been linked to the QLD Hospital Admitted Patient Data Collection, QLD Hospital Non-Admitted Patient Data Collection, QLD Emergency Department Data Collection, and Medicare Benefits Schedule and Pharmaceutical Benefits Scheme Claims Records between 1 and 2012 to 30th June 2019. RESULTS: Culturally and linguistically diverse infants born with low birthweight had higher mean and standard deviation of all health events and outcomes; potentially preventable hospitalisations, hospital re-admissions, ED presentations without admissions, and development of chronic diseases compared to non-CALD infants born with low birthweight. DISCUSSION: Results from this study highlight the disparities in health service use and health events and outcomes associated with low birthweight infants, between both CALD and Australian born women. This study has responded to the knowledge gap of low birthweight on the Australian economy by identifying that there are significant inequalities in access to health services for CALD women in Australia, as well as increased health events and poor birth outcomes for these infants when compared to those of mothers born in Australia.

Patterns in the provision of government-subsidised hormonal postpartum contraception in Queensland, Australia between 2012 and 2018: a population-based cohort study.

BACKGROUND: Short birth intervals and unintended pregnancy are associated with poorer maternal and infant outcomes. There is a risk of pregnancy during the immediate postpartum period unless contraception is initiated. This retrospective cohort study aimed to capture the current patterns of hormonal contraceptive provision within 12 months postpartum in a high-income country. METHODS: We used a linked administrative dataset comprising all women who gave birth in Queensland, Australia between 1 July 2012 and 30 June 2018 (n=339 265 pregnancies). We described our cohort by whether they were provided with government-subsidised hormonal contraception within 12 months postpartum. The associations between hormonal postpartum contraceptive provision and demographic and clinical characteristics were examined using univariate and multivariate logistic regression and presented in terms of crude and adjusted odds ratios with 95% confidence intervals. RESULTS: A majority of women (60.2%) were not provided with government-subsidised hormonal postpartum contraception within 12 months postpartum. Women who were younger (<25 years), were overweight or obese, smoked, were born in Australia, were non-Indigenous, gave birth in a public hospital, or were in the lowest socioeconomic status group were more likely to be provided with postpartum contraception after adjusting for other covariates, compared with their counterparts. CONCLUSIONS: Strategies to increase the provision and uptake of contraception in the immediate postpartum period are needed to prevent short birth intervals and unintended pregnancy and ensure women's fertility intentions are enacted. Ongoing research is needed to examine the factors influencing women's access to contraceptive services and, further, the types of contraception provided.

Applying a simplified economic evaluation approach to evaluate infertility treatments in clinical practice.

IVF is the backbone of infertility treatment, but due to its costs, it is not affordable for everyone. The cost of IVF is further escalated by interventions added to the routine treatment, which are claimed to boost pregnancy rates, so-called add-ons. Consequently, it is critical to offset the increased costs of an intervention against a potentially higher benefit. Here, we propose using a simplified framework considering the cost of a standard IVF procedure to create one live-born baby as a benchmark for the cost-effectiveness of other fertility treatments, add-ons inclusive. This framework is a simplified approach to a formal economic evaluation, enabling a rapid assessment of cost effectiveness in clinical settings. For a 30-year-old woman, assuming a 44.6% cumulative live birth rate and a cost of $12 000 per complete cycle, the cost to create one live-born baby would be ∼$27 000 (i.e. willingness to pay). Under this concept, the decision whether to accept or reject a new treatment depends from an economic perspective on the incremental cost per additional live birth from the new treatment/add-on, with the $27 000 per live-born baby as a reference threshold. This threshold can vary with women's age, and other factors such as the economic perspective and risk of side effects can play a role. If a new add-on or treatment costs >$27 000 per live birth, it might be more rational to invest in a new IVF cycle rather than spending on the add-on. With the increasing number of novel technologies in IVF and the lack of a rapid approach to evaluate their cost-effectiveness, this simplified framework will help with a more objective assessment of the cost-effectiveness of infertility treatments, including add-ons.

Designing economic evaluations alongside clinical trials in maternal health care: A guide for clinical trial design.

BACKGROUND: Economic evaluations are being conducted with increasing frequency in the maternity care setting, with more randomized controlled trials containing a health economic component. Key emerging criticisms of economic evaluation in maternity care are lack of robust data collection and measurement, inconsistencies in methodology, and lack of adherence to reporting guidelines. METHODS: This article provides a guide to the design of economic evaluations alongside clinical trials in maternal health. We include economic concepts and considerations for the maternity setting and provide examples from the UK and Australia. RESULTS: There are many important considerations for the design of economic evaluations alongside clinical trials. To be effective, researchers must select types of economic evaluation, which align with their study objectives; choose an appropriate evaluation perspective, time horizon, and discount rate; and identify accurate ways to measure and evaluate health outcomes and costs. DISCUSSION: This guide is written for noneconomists and can be used for designing economic evaluations to be conducted as a part of clinical trials. We seek to improve the quality, consistency, and transparency of economic evaluations in maternal health.

The value of maternity care in Queensland, 2012-18, based on an analysis of administrative data: a retrospective observational study.

OBJECTIVE: To quantify the value of maternity health care - the relationship of outcomes to costs - in Queensland during 2012-18. STUDY DESIGN: Retrospective observational study; analysis of Queensland Perinatal Data Collection data linked with the Queensland Health Admitted Patient, Non-Admitted Patient, and Emergency Data Collections, and with the Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) databases. SETTING, PARTICIPANTS: All births in Queensland during 1 July 2012 - 30 June 2018. MAIN OUTCOME MEASURES: Maternity care costs per birth (reported in 2021-22 Australian dollars), both overall and by funder type (public hospital funders, MBS, PBS, private health insurers, out-of-pocket costs); value of care, defined as total cost per positive birth outcome (composite measure). RESULTS: The mean cost per birth (all funders) increased from $20 471 (standard deviation [SD], $17 513) during the second half of 2012 to $30 000 (SD, $22 323) during the first half of 2018; the annual total costs for all births increased from $1.31 billion to $1.84 billion, despite a slight decline in the total number of births. In a mixed effects linear analysis adjusted for demographic, clinical, and birth characteristics, the mean total cost per birth in the second half of 2018 was $9493 higher (99.9% confidence interval, $8930-10 056) than during the first half of 2012. The proportion of births that did not satisfy our criteria for a positive birth outcome increased from 27.1% (8404 births) during the second half of 2012 to 30.5% (9041 births) during the first half of 2018. CONCLUSION: The costs of maternity care have increased in Queensland, and many adverse birth outcomes have become more frequent. Broad clinical collaboration, effective prevention and treatment strategies, as well as maternal health services focused on all dimensions of value, are needed to ensure the quality and viability of maternity care in Australia.