An innovative low-cost breast pump-hire program to enhance breastfeeding rates in a neonatal intensive care unit.

AIM: To evaluate the outcomes of a low-cost hospital-grade breast pump hire program for women experiencing financial hardship with infants in neonatal intensive care. DESIGN: A multi-method evaluation including data audits and surveys. METHODS: Twenty-four electric breast pumps were purchased and rented to mothers at a cost of $1/day. To be eligible, mothers needed to have given birth to an infant <32 weeks and/or <1500 g and self-identified as experiencing financial hardship. Data were collected by (1) a retrospective audit to evaluate infant feeding and clinical outcomes at hospital discharge; (2) prospective telephone surveys to evaluate women's satisfaction with the program; and (3) analysis of the breast pump register to determine any loss or damages. RESULTS: Twenty-four mothers of 26 infants participated in the program. More than half of the infants were exclusively breastmilk fed at hospital discharge, and more than three-quarters were fed a combination of breastmilk and formula. Women who intended to formula feed were supported to provide breastmilk to their infants in the first few weeks of life. Most participants were highly satisfied with the program. Women reported that accessibility to a hospital-grade breast pump improved their ability to provide expressed breastmilk to their infants. Most participants were 'extremely satisfied' with the performance of the breast pump. One-quarter of the women reported that they would have exclusively formula-fed if they did not have access to the breast pump hire program. The audit of the equipment register showed no reported technical issues, loss or damages. CONCLUSION: The findings suggested that the low-cost breast pump hire program supported equitable care, increasing women's ability to provide expressed breastmilk for their infants. IMPACT: Providing access to low-cost hospital-grade breast pumps to mothers of vulnerable infants is likely to prevent poor infant clinical outcomes and improve women's care satisfaction. PUBLIC OR PATIENT CONTRIBUTION: Nil.

Sustainability of rural Victorian maternity services: 'We can work together'.

BACKGROUND: Rural maternity service closures and service level reductions are continually increasing across Victoria. There is limited understanding of how rural board members and executives make decisions about their maternity service's operations and sustainability. AIM: To examine perspectives of rural Victorian board members and executives on the sustainability of rural maternity services. METHODS: This was a qualitative study. Interviews were conducted via Zoom™ with 16 rural Victorian hospital board members and executives. Data were thematically analysed. FINDINGS: Severe shortages in the rural maternity workforce, primarily midwives, have contributed to service sustainability decisions. Challenges in offering midwifery workforce incentives cause difficulty in overcoming workforce shortages. A rural maternity workforce strategy harnessing connection with regional services was called for. Innovative models of maternity care were often actioned at the point of service suspension or closure. Participants requested a government policy position and funding for innovative, safe, and sustainable models of care in rural settings. DISCUSSION: There is an opportunity for workforce planning to occur between regional and rural services to ensure the development of sustainable maternity models such as midwifery group practice and incentivise the workforce to address current deficits and sustain service provision. CONCLUSION: Models of care developed with rural communities, in collaboration with regional services, have the potential to strengthen the delivery of safe, sustainable maternity services. Workforce modelling and centralised government policies aimed at arresting workforce deficits are suggested to provide rural health service leaders with strategic and operational directions to support the delivery of safe, sustainable maternity services.

Trends and disparities in perinatal health outcomes among women from refugee backgrounds in Victoria, Australia: A population-based study.

BACKGROUND: Women from refugee backgrounds generally experience poorer pregnancy-related outcomes compared to host populations. AIM: To examine the trend and disparities in adverse perinatal outcomes among women of refugee background using population-based data from 2003 to 2017. METHODS: A population-based cross-sectional study of 754,270 singleton births in Victoria compared mothers of refugee backgrounds with Australian-born mothers. Inferential statistics, including Pearson chi-square and binary logistic regression, were conducted. Multiple logistic regression was conducted to explore the relationship between adverse perinatal outcomes and the women's refugee status. FINDINGS: Women of refugee background had higher odds of adverse neonatal and maternal outcomes, including stillbirth, neonatal death, low APGAR score, small for gestational age, postpartum haemorrhage, abnormal labour, perineal tear, and maternal admission to intensive care compared to Australian-born women. However, they had lower odds of neonatal admission to intensive care, pre-eclampsia, and maternal postnatal depression. The trend analysis showed limited signs of gaps closing over time in adverse perinatal outcomes. DISCUSSION AND CONCLUSION: Refugee background was associated with unfavourable perinatal outcomes, highlighting the negative influence of refugee status on perinatal health. This evidences the need to address the unique healthcare requirements of this vulnerable population to enhance the well-being of mothers and newborns. Implementing targeted interventions and policies is crucial to meet the healthcare requirements of women of refugee backgrounds. Collaborative efforts between healthcare organisations, government agencies and non-governmental organisations are essential in establishing comprehensive support systems to assist refugee women throughout their perinatal journey.

Breastfeeding and pre-pregnancy bariatric surgery: A scoping review.

BACKGROUND: Bariatric surgery is a procedure for people with class II and III obesity who are unable to lose weight using traditional methods. The incidence rate of bariatric surgery in reproductive-age women is increasing rapidly, so the number of women who become pregnant after bariatric surgery is rising. AIM: To collate and synthesise available literature regarding breastfeeding following bariatric surgery. METHODS: This review was reported by the preferred reporting items for systematic reviews and meta-analysis extension for scoping reviews (PRISMA-Scr). The review included peer-reviewed research studies and research-based conference abstracts on breastfeeding outcomes in mothers who have undergone bariatric surgery before pregnancy. Health databases were searched from 1990 to December 2023. Included studies were analysed using a narrative synthesis. FINDINGS: From 1506 abstracts, 16 papers were identified. Three themes emerged from the analysis: challenges in exclusive breastfeeding, nutritional composition in breast milk, and breastfeeding experience. There was a tendency for lower breastfeeding rates and shorter durations in mothers who had bariatric surgery. Most studies focussed on the nutritional composition of breast milk however these results were mixed. Only three articles were qualitative, and their findings showed that women wanted more information and support about breastfeeding following bariatric surgery. DISCUSSION: Our review indicates breastfeeding challenges in post-bariatric surgery mothers and reduced breastfeeding rates. It is unclear whether bariatric surgery impacts the nutritional quality of breast milk due to inconsistent study outcomes. CONCLUSION: Future research is essential, specifically on understanding the breastfeeding concerns and experiences of women who have undergone bariatric surgery.

The barometer of moral distress in midwifery: A pilot study.

BACKGROUND: Moral distress is a phenomena that occurs following a compromise to moral beliefs. Moral distress has been reported across health professions, including midwifery. Although there are validated tools to assess for moral distress, none have been identified that suit the Australian healthcare system or midwifery. AIM: The aim of this study was to pilot the Barometer of Moral Distress in Midwifery. METHODS: This study was the fourth stage of a mixed method project. Using a cross-sectional approach, a survey tool including demographic questions, the Barometer of Moral Distress in Midwifery, and the Copenhagen Burnout Inventory assessed tool stability, reliability, and validity. FINDINGS: A total of 103 surveys were completed. A test-retest demonstrated tool reliability and stability (a =.97). Factor analysis confirmed internal consistency; Factor 1 - Professional Identity (a=.91), Factor 2 - Inadequate Resources (a=.85), and Factor 3 - Unethical Cultures (a=.88). Concurrent validity was demonstrated through positive correlations between self-reported types of moral distress with mean scores for each Factor. Strong correlations were identified between work-related burnout and mean scores, while only weak correlations were noted between client-related burnout and mean scores. Only Factor 1 demonstrated a correlation between leaving the profession and mean scores. DISCUSSION/CONCLUSION: This was the first moral distress tool that assessed both frequency of exposure and psychological outcomes to score moral distress. Findings indicate that moral distress in midwifery is not associated with caring work but with occupational environments. Further research is required to assess self-sacrifice in moral distress.

An assessment of ten popular pregnancy applications (Apps) available for women in Australia.

OBJECTIVE: Given the growing popularity of health Apps, this study aimed to evaluate popular pregnancy Apps among Australian women. DESIGN: Ten popular pregnancy mobile device Apps accessible within Australia were assessed using the Deakin Health E-technologies Assessment Lab (HEAL) framework, the Australian Privacy Principles (APP) and other context-specific criteria. RESULTS: Most Apps were robust in use and user-friendly in terms of design. Based on the HEAL assessment, all the Apps scored between 70 and 89 out of 120. Only two of the ten Apps were locally hosted and operated. Only one App could search local health services using Victorian postcodes. All ten Apps were aligned with various privacy policy guidelines, but only one was reported to be fully aligned with the APP as it is locally hosted and operated. None of the Apps had accessibility features such as for visual or hearing difficulties. Only one App could be assessed as able to interface with the electronic medical record system in Australia due to a lack of publicly available information on this capability. CONCLUSIONS: Due to privacy concerns, pregnancy Apps accessible in Australia should be used with caution unless care is taken to select an App that fully complies with local requirements or international equivalents. All Apps were subjectively rated as moderate in quality, and more attention to accessibility and privacy features by App developers is recommended, along with the focus on integration with Australian digital health services.

Community Practices, Published Guidelines, and Evidence Base Surrounding Breast Milk Handling and Storage: A Qualitative Study.

Background: Expressed breast milk (EBM) is the best alternative to direct breastfeeding. However, expressing breast milk requires good milk handling and storage practices to preserve EBM safety and integrity. Mothers require handling and storage guidance, and many seek this from the internet and online support groups. Aim: This study aimed at exploring EBM handling and storage practices within an online exclusively expressing community and comparing these with both internet resources and evidence-based research. Methods: A naturalistic observational design was used. Content analysis was undertaken on 10,000 posts from an Australian Facebook peer-support community for women who exclusively express breast milk. Women's questions, reported practices, and advice for EBM handling and storage were analyzed thematically and compared with both guidelines and evidence-based research. Findings: There were 460 posts on EBM handling and storage. Three key themes emerged: "How should I store my EBM?," "How long can I store my EBM?," and "How do I use my EBM?" The greatest consistency and agreement between recommendations and community practices were found for storage methods, whereas the least was found for storage times. EBM handling and storage practices were influenced by factors such as EBM value, convenience, and cost, leading to occasional deviations from consistent practice recommendations. Conclusion: To facilitate safe EBM handling and continuation of expression, guidelines should be updated so they are consistent, align with current evidence, and cater to mothers' cost, convenience, and milk wastage concerns. Health care providers can partner with women to evaluate online information to empower mothers in their decision making.

Development of the essential learning outcomes for the midwifery student continuity of care learning model: A Delphi study.

BACKGROUND: In Australia, midwifery students are required to undertake at least ten Continuity of Care Experiences (CoCE) during their education. The learning outcomes of this experience have never been explicit or standardised resulting in inconsistent assessment. AIM: To develop and identify standardised learning outcomes for the CoCE. METHODS: A modified Delphi survey was conducted with an expert panel. Intended learning outcome statements were developed, reflecting the learning objectives identified in a previous study. Bloom's taxonomy levels of thinking complexities guided the wording of the outcomes. Participants were asked to rank and rate their level of agreement with each statement over two survey rounds. FINDINGS: Round one was completed by 32 participants, with 92.5% of the 40 statements reaching consensus. The second round was completed by 23 participants, with 70.7% of the 33 statements reaching consensus. Content analysis of participant comments from each round identified duplicates that were removed and informed refining the wording of some statements. A final set of 15 learning outcomes were agreed upon. The outcomes were broadly grouped within the themes of accountability, advocacy, and autonomy. DISCUSSION: This study has identified agreed learning outcomes for midwifery students undertaking CoCE. The consensus agreement of experts reinforced the learning model enables the development of woman-centred practice that is underpinned by accountability, advocacy, and autonomy. CONCLUSION: Purposeful learning outcomes for the CoCE have been developed, informing how the model can be embedded in curricula, guide student learning and assessment to standardise the pedagogy of the model to prepare future midwives.

Barriers and enablers to antenatal care attendance for women referred to social work services in a Victorian regional hospital: A qualitative descriptive study.

BACKGROUND: Women referred to social work services during pregnancy are more likely to experience social disadvantage than those who are not, resulting in reduced antenatal care attendance. Lack of antenatal care engagement leads to poor identification and management of concerns that can have immediate and long-term health consequences for women and their babies. Identifying the barriers and enablers to antenatal care attendance for women referred to social work services is important for designing models of care that promote effective engagement. AIMS: This study aimed to explore the barriers and enablers to antenatal care attendance by women referred to social work services from the perspectives of women, and clinicians who provide antenatal healthcare. METHODS: A qualitative descriptive study using constructivist grounded theory methods was undertaken. Ten women referred to social work services and 11 antenatal healthcare providers were purposively recruited for interviews from a regional maternity service in Victoria, Australia. FINDINGS: Continuity of care and healthcare providers partnering with women were central to effective engagement with antenatal care services. Three interrelated concepts were identified: 1) experiences of the hospital environment and access to care; 2) perceptions of care influence engagement, and 3) motivations for regularly attending services. CONCLUSIONS: Continuity of care is essential for supporting women referred to social work services to attend antenatal appointments. Women are better equipped to overcome other barriers to antenatal service attendance when they have a strong partnership with clinicians involved in their care.

Satisfaction with maternity triage following implementation of the Birmingham Symptom-Specific Obstetric Triage System (BSOTS): Perspectives of women and staff.

AIM: To explore the satisfaction and experiences of women and staff with the BSOTS in an Australian hospital. DESIGN: Cross-sectional descriptive survey. METHODS: Surveys were distributed to women and staff between February and May 2022. Survey questions reflected satisfaction with triage and provision of care under the BSOTS system (for women) and confidence in using the BSOTS system and its impact on triage-related care (for staff). Survey data were summarized using descriptive statistics, and qualitative responses were analysed using content analysis. RESULTS: There were 50 women and 40 staff (midwives and doctors) survey respondents. Most women were satisfied with triage wait times, the verbal information they received and the time it took for them to receive care. Nearly all midwife participants indicated they had high knowledge and confidence in using the BSOTS. Most staff indicated that the BSOTS supported the accurate assessment of women and had benefits for women, staff and the hospital. CONCLUSION: The findings showed that women and staff were satisfied with receiving and providing care in a maternity triage setting under the BSOTS system. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Implementing standardized maternity triage approaches such as the BSOTS in health settings delivering care to pregnant women is recommended for improving flow of care and perceptions of care quality by women. IMPACT: Quality of maternity triage processes is likely to impact the satisfaction of women attending services and the staff providing care. The BSOTS was shown to improve maternity triage processes and was associated with satisfaction of women and staff. Maternity settings can benefit from implementing triage approaches such as the BSOTS as it standardizes and justifies the care provided to women. This is likely to result in satisfaction of women and staff engaged in maternity triage and improve the birth outcomes of women and babies. REPORTING METHOD: The reporting of this paper has followed SQUIRE guidelines. PATIENT OR PUBLIC CONTRIBUTION: Women engaged with maternity services were participants in the study but did not contribute to the design, conduct or publication of the study.

Pregnant women with diabetes and their clinician's experience of participating in a pilot randomised controlled trial of corticosteroid administration in late pregnancy: A qualitative study.

BACKGROUND: Little research exists to support the administration of corticosteroids to pregnant women with diabetes. Pregnant women are often excluded from clinical trials due to concerns of harm to the foetus. AIM: This study aimed to understand the experiences of women and clinicians of participating in the Prevention of neonatal Respiratory distress with antenatal corticosteroids before Elective Caesarean section in women with Diabetes pilot randomised controlled trial to determine the acceptability of the study protocol. METHODS: Women and clinicians participating in the pilot trial were invited to complete a telephone interview regarding their experiences of participating. Qualitative data were collected and subsequently analysed using thematic analysis. RESULTS: A total of 13 women and nine clinicians were recruited between June 2020 and May 2022 for a telephone interview. Participating in the study was deemed acceptable by women and clinicians. Women chose to participate in the study due to the perceived low risk of harm associated with the intervention and for altruistic reasons. The high level of clinical support and information provided for the duration of the pilot trial was valued by women and clinicians. All clinicians highlighted the importance of conducting the trial to inform evidence-based practice. CONCLUSIONS: Pregnant women are more likely to participate in clinical trials when perceived risks are low and they are well-informed during decision-making. Clinicians will support clinical trials when they perceive a benefit to practice and feel assured that women receive extensive monitoring and support. Incorporating these factors into study protocols is more likely to be successful in recruiting pregnant women and maintaining the engagement of clinical staff for the duration of clinical trials. PATIENT OR PUBLIC CONTRIBUTIONS: Patients were invited to be participants in this study. A consumer has been included in the planning and oversite of the large multicentre trial.

Maternity clinician use of shared decision-making in antenatal care: A scoping review.

BACKGROUND: Implementation of shared decision-making in antenatal care has had limited exploration. OBJECTIVE: To assess what is known about shared decision-making in antenatal care. SEARCH STRATEGY: Five databases were searched (1997-2022) limited to English language studies from OECD countries. DATA COLLECTION AND ANALYSIS: A data collection table was constructed with findings from 32 papers. A narrative synthesis was conducted with subsequent thematic analysis of included papers. MAIN RESULTS: Four areas of decision-making were identified with six themes revealing enablers and barriers to shared decision-making in antenatal care. CONCLUSION: Implementation of shared decision-making requires continuity, time and personalisation of care.

A survey of Australian women's digital media usage in pregnancy and labour and birth.

BACKGROUND: Given the rapid growth of digital media resources, it is worth exploring childbearing women's use of digital media to address their information needs. The aim of this study was to explore the use of digital media during pregnancy and birth in the local population of Western Victorian women in Melbourne, Australia. METHODS: A descriptive exploratory approach was used. An online survey consisted of both quantitative and qualitative questions to identify and measure digital media use in pregnancy and the birthing period. Descriptive statistics and Pearson Chi-square test were used to analyse the quantitative data, while content analysis was used to analyse the qualitative data. RESULTS: Digital media has become an integral part of the experience in pregnancy with increasing growth of digital media in labour. The most used medium for digital media use was pregnancy applications, followed by websites, social media, YouTube, podcasts, online discussion forums and lastly, labour applications. Information seeking was the main reason for using digital media, and two main themes emerged from the qualitative data; 'connection with others for social support and reassurance' and 'information seeking and providing to assist decision making and providing reassurance'. CONCLUSION: This study highlights the need for future midwifery practice to include digital media sources in antenatal education and care. There is a need for healthcare institutions to improve digital media technology to meet the needs of women. This is crucial as digital media is constantly evolving, and as healthcare providers, we need to integrate digital media with healthcare services.

Advocacy, accountability and autonomy; the learning intention of the midwifery student continuity of care experience.

PROBLEM: The Continuity of Care Experience is a mandated inclusion in midwifery education programs leading to registration as a midwife in Australia. The practice-based learning experience has evolved over time, yet there remains no standardised learning intentions, objectives, or outcomes for the model. AIM: To identify the key learning intentions of the Continuity of Care Experience by an expert panel to support the development of learning outcomes. METHODS: A descriptive qualitative study with two focus groups were conducted with an expert panel (n = 15). Participants were midwifery education subject matter experts on the Continuity of Care Experience with backgrounds in academia, policy development, curriculum design, accreditation, or clinical education. The discussions were transcribed and thematically analysed. FINDINGS: Three main themes and six sub-themes describe the learning intentions of the Continuity of Care Experience. The main themes were: (1) advocacy for women; (2) accountability of care; and (3) autonomy in practice. DISCUSSION: The education model of continuity of care enables students to develop midwifery practice that involves advocating for women, being accountable for their care and being autonomous in practice. We have established that during the experience students practice in partnership with women and are exposed to the full scope of midwifery care. Importantly students learn holistic woman-centred practice. CONCLUSION: The learning intentions of the Continuity of Care Experience reflects woman-centred practice. Having identified a common understanding of the learning intention, these can now be used to design learning, and assessment, through the development of measurable learning outcomes.

In what ways does maternity care in Australia align with the values and principles of the national maternity strategy? A scoping review.

Australia's national maternity strategy Woman-centred care: strategic directions for Australian maternity services (the Strategy) was released by the federal government in November 2019. It was developed to provide national guidance on the effective provision of woman-centred maternity care. The Strategy is structured around four values of safety, respect, choice, and access, and underpinned by twelve principles of woman-centred care. By examining previous research, this review aims to provide a baseline understanding of how maternity care provision is being met in relation to these core values. A systematic search of Australian literature was undertaken via four databases using the Strategy's values and 41 articles met the selection criteria. Include articles were predominantly published pre-2019, providing a baseline understanding of Australian maternity care provision prior to the Strategy's publication. Findings suggest that the four values align with those of women; however, women were not always receiving care in accordance with the values, particularly among women from priority populations. Women prioritised safety for themselves and their babies, articulated the need for respectful relationships with maternity care providers, wanted autonomy to make their own decisions, and desired access to appropriate, local, maternity services. Additionally, while pockets of appropriate care do exist, these are more likely to occur at a single-service level than more broadly at a population level. This implies the Strategy is needed, and its operationalisation must be prioritised through a coordinated national response to better meet the maternity care needs of Australian women. Further research is warranted to determine the Strategy's effectiveness.

The Green Maternity project: A midwife-led initiative to promote correct waste segregation on an Australian postnatal ward.

AIMS: Healthcare waste production is a significant contributor to carbon emissions, negatively impacting the environment. Ineffective healthcare waste disposal results in greater measures to manage it which is costly to both the environment and healthcare organizations. This study aimed to improve waste management in a tertiary maternity hospital. Specifically, the impact of a midwife-led intervention to improve waste segregation, staff knowledge and attitudes and waste management-related costs was investigated. DESIGN: A multi-method study including pre- and post-intervention staff waste management knowledge and attitude surveys and waste audits of bins located on the postnatal ward. METHODS: The intervention included education sessions, posters and signage by waste bins and monthly newsletters distributed throughout 2021 to raise staff awareness of correct waste segregation processes. Pre- and post-intervention surveys were distributed in early 2021 and early 2022, respectively. The waste audits occurred on three occasions, January, July and December of 2021. The waste audit included total waste in kilograms (kg), waste in kg by segregation and identification of correct and incorrect segregation. Waste audit and quantitative staff survey data were analysed using descriptive statistics and chi square. Qualitative data from the staff surveys were analysed using content analysis. RESULTS: Knowledge and attitudes to waste management were similar across pre- and post-intervention staff surveys. Knowledge of accurate allocation of specific items to waste streams was variable with errors identified in both the pre- and post-surveys. Waste audit data showed reductions in clinical waste at each measurement, with a 71.2% decrease in clinical waste from baseline to the final audit. Accuracy of waste segregation also improved from the baseline to final audit, resulting in a 48% reduction in waste management costs. CONCLUSION: The midwife-led initiative improved waste segregation and achieved the associated waste management cost reduction. IMPACT: A midwifery-led initiative to address waste production and segregation on a maternity ward had a positive impact on waste segregation practices and associated waste management costs. The existence of change champions along with in-service sessions, posters and newsletters to raise awareness of correct waste segregation resulted in a 71% reduction of incorrect items being placed in clinical waste bins. Challenges such as COVID-19 pressures and workload made it difficult for midwives to engage in waste management education and effective waste segregation. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Implementing clinician-led waste management interventions across hospital wards while addressing workload issues are likely to have significant cost benefits for organisations and minimise the environmental impacts of healthcare settings.

Moral distress in midwifery practice: A Delphi study.

BACKGROUND: Moral distress is a psychological concept that describes the harm associated with actions or inactions that oppose an individuals' moral beliefs. Moral distress is linked to moral compromise in the workplace that may negatively impact mental wellbeing. Current tools available to assess moral distress are not specific for the Australian health care system or midwifery practice. AIM: The aim of this study was to develop a list of situational and outcome statements associated with moral compromise and levels of moral distress in midwifery to inform the development of a tool to measure levels of moral distress in midwives. METHODS: This e-Delphi study was the third stage of a sequential exploratory mixed-methods study. Using an online strategy, three iterative rounds of e-Delphi were collected and analysed for consensus on situations leading to moral distress and the associated psychological outcomes. FINDINGS: Twenty participants contributed across the three rounds. Consensus was met in 40 morally compromising situation statements. The highest level of consensus related to excessive workloads and the associated negative impact of this on women and families. Consensus on outcomes following exposure to morally distressing situations led to the development of a continuum scale from moral frustration to moral injury. DISCUSSION/CONCLUSION: This is the first study to use a consensus method to establish different levels of moral compromise, frustration, distress, and injury in midwifery practice. The findings of this study contribute to a growing body of literature that supports the concept of moral distress occurring across a continuum.

PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial.

OBJECTIVE: The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a multicentre, randomised controlled trial (RCT) to assess the efficacy of antenatal corticosteroids administration within 7 days before elective caesarean section (CS) in women with pre-gestational diabetes (PGDM) or gestational diabetes (GDM). DESIGN: Triple blind, parallel group, placebo-controlled, pilot RCT. SETTING: Single-centre tertiary maternity hospital in Melbourne, Australia. POPULATION: Pregnant women with PGDM (type 1 or type 2 diabetes) or GDM booked for a planned CS scheduled between 35+0 and 38+6 weeks of gestation. METHODS: Eligible participants were randomised to receive two injections of either betamethasone 11.4 mg or normal saline placebo, 24 hours apart within 7 days before CS scheduled between 35+0 and 38+6 weeks of gestation. MAIN OUTCOME MEASURE: The proportion of eligible women who consented and were randomised. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12619001475134. RESULTS: Of 537 women eligible, 182 were approached and 47 (26%) were recruited. Of these, 22 were allocated to the betamethasone group and 25 were allocated to the placebo group. There were no serious adverse events related to participation. CONCLUSION: It is feasible to undertake a triple-blind, placebo-controlled RCT investigating the efficacy of antenatal corticosteroids in preventing respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35+0 and 38+6 weeks.