Experiences of antenatal care practices to reduce stillbirth: surveys of women and healthcare professionals pre-post implementation of the Safer Baby Bundle.

BACKGROUND: The Safer Baby Bundle (SBB) aimed to reduce stillbirth rates in Australia through improving pregnancy care across five elements; smoking cessation, fetal growth restriction (FGR), decreased fetal movements (DFM), side sleeping in late pregnancy and decision making around timing of birth. We assessed experiences of women and healthcare professionals (HCPs) with antenatal care practices around the five elements. METHODS: A pre-post study design using online surveys was employed to assess change in HCPs awareness, knowledge, and frequency of performing recommended practices (22 in total) and women's experiences of care received related to reducing their chance of stillbirth. Women who had received antenatal care and HCPs (midwives and doctors) at services participating in the SBB implementation program in two Australian states were invited to participate. Surveys were distributed over January to July 2020 (pre) and August to December 2022 (post). Comparison of pre-post responses was undertaken using Fisher's exact, Pearson's chi-squared or Wilcoxon rank-sum tests. RESULTS: 1,225 women (pre-1096/post-129) and 1,415 HCPs (pre-1148/post-267, ≥ 83% midwives) completed the surveys. The frequency of HCPs performing best practice 'all the time' significantly improved post-SBB implementation across all elements including providing advice to women on side sleeping (20.4-79.4%, p < 0.001) and benefits of smoking cessation (54.5-74.5%, p < 0.001), provision of DFM brochure (43.2-85.1%, p < 0.001), risk assessments for FGR (59.2-84.1%, p < 0.001) and stillbirth (44.5-73.2%, p < 0.001). Practices around smoking cessation in general showed less improvement e.g. using the 'Ask, Advise and Help' brief advice model at each visit (15.6-20.3%, p = 0.088). Post-implementation more women recalled conversations about stillbirth and risk reduction (32.2-50.4%, p < 0.001) and most HCPs reported including these conversations in their routine care (35.1-83.0%, p < 0.001). Most HCPs agreed that the SBB had become part of their routine practice (85.0%). CONCLUSIONS: Implementation of the SBB was associated with improvements in practice across all targeted elements of care in stillbirth prevention including conversations with women around stillbirth risk reduction. Further consideration is needed around strategies to increase uptake of practices that were more resistant to change such as smoking cessation support. 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.

Investigating Menstruation and Adverse Pregnancy Outcomes: Oxymoron or New Frontier? A Narrative Review.

Not discounting the important foetal or placental contribution, the endometrium is a key determinant of pregnancy outcomes. Given the inherently linked processes of menstruation, pregnancy and parturition with the endometrium, further understanding of menstruation will help to elucidate the maternal contribution to pregnancy. Endometrial health can be assessed via menstrual history and menstrual fluid, a cyclically shed, easily and non-invasively accessible biological sample that represents the distinct, heterogeneous composition of the endometrial environment. Menstrual fluid has been applied to the study of endometriosis, unexplained infertility and early pregnancy loss; however, it is yet to be examined regarding adverse pregnancy outcomes. These adverse outcomes, including preeclampsia, foetal growth restriction (FGR), spontaneous preterm birth and perinatal death (stillbirth and neonatal death), lay on a spectrum of severity and are often attributed to placental dysfunction. The source of this placental dysfunction is largely unknown and may be due to underlying endometrial abnormalities or endometrial interactions during placentation. We present existing evidence for the endometrial contribution to adverse pregnancy outcomes and propose that a more comprehensive understanding of menstruation can provide insight into the endometrial environment, offering great potential value as a diagnostic tool to assess pregnancy risk. As yet, this concept has hardly been explored.

Creatine and pregnancy outcomes: a prospective cohort study of creatine metabolism in low-risk pregnant females.

BACKGROUND: Physiological adaptations during pregnancy alter nutrient and energy metabolism. Creatine may be important for maintaining cellular energy homeostasis throughout pregnancy. However, the impact of pregnancy on endogenous and exogenous creatine availability has never been comprehensively explored. OBJECTIVES: To undertake a prospective cohort study and determine the physiological ranges of creatine and associated metabolites throughout human pregnancy. METHODS: Females with a singleton low-risk pregnancy were recruited at an Australian health service. Maternal blood and urine were collected at 5-time points from 10-36 weeks of gestation, and cord blood and placental samples were collected at birth. Creatine and associated amino acids and metabolites of creatine synthesis were analyzed. Dietary data were captured to determine effects of exogenous creatine intake. Associations between creatine metabolism and neonatal growth parameters were examined. RESULTS: Two hundred and eighty-two females were included. Maternal plasma creatine remained stable throughout pregnancy [ß: -0.003 µM; 95% confidence interval (CI): -0.07, 0.07; P = 0.94], though urinary creatine declined in late gestation (ß: 0.38 µM/mmol/L creatinine (CRN); 95% CI: -0.47, -0.29; P < 0.0001). Plasma guanidinoacetate (GAA; the precursor to creatine during endogenous synthesis) fell from 10-29 weeks of gestation before rising until birth (ß: -0.38 µM/mmol/L CRN; 95% CI: -0.47, -0.29; P < 0.0001). Urinary GAA followed an opposing pattern (ß: 2.52 µM/mmol/L CRN; 95% CI: 1.47, 3.58, P < 0.001). Animal protein intake was positively correlated with maternal plasma creatine until ∼32 weeks of gestation (ß: 0.07-0.18 µM; 95% CI: 0.006, 0.25; P ≤ 0.001). There were no links between creatine and neonatal growth, but increased urinary GAA in early pregnancy was associated with a slight reduction in head circumference at birth (ß: -0.01 cm; 95% CI: -0.02, -0.004; P = 0.003). CONCLUSIONS: Although maternal plasma creatine concentrations were highly conserved, creatine metabolism appears to adjust throughout pregnancy. An ability to maintain creatine concentrations through diet and shifts in endogenous synthesis may impact fetal growth. This trial was registered at [registry name] as ACTRN12618001558213.

The effects of intravenous hydration regimens in nulliparous women undergoing induction of labor: A systematic review and meta-analysis.

INTRODUCTION: Labor is both a physiological and physical activity that requires energy expenditure by the woman. Despite this, women are often fasted in labor, with hydration requirements addressed predominantly by intravenous therapy. Little is known about how best to manage this in nulliparous women undergoing induction of labor, who can be prone to lengthy labors. Therefore, we undertook a systematic review and meta-analysis to determine the effects of intravenous hydration regimens on nulliparous women undergoing induction of labor. MATERIAL AND METHODS: A systematic review and meta-analysis were conducted. Databases searched were PubMed, CINAHL, Embase, Cochrane, Scopus, and Web of Science using the search strategy combination of associated key concepts for intravenous therapy and nulliparous laboring women. The primary outcome was excessive neonatal weight loss. Meta-analyses for categorical outcomes included estimates of odds ratio (OR) and their 95% confidence intervals (CI) calculated; and for continuous outcomes the standardized mean difference, each with its 95% CI. Heterogeneity was assessed visually and by using the χ2 statistic and I2 with significance being set at p < 0.10. RESULTS: A total of 1512 studies were located and following screening, three studies met the eligibility criteria. No studies reported excessive neonatal weight loss. Increased rates of intravenous therapy (250 mL/h vs. 125 mL/h) during labor were not found to reduce the overall length of labor (mean difference -0.07 h, 95% CI -0.27 to 0.13 h) or reduce cesarean sections (OR 0.74, 95% CI 0.45-1.23), when women were not routinely fasted. CONCLUSIONS: Our review found no significant improvements for nulliparous women who received higher intravenous fluid volumes when undergoing induction of labor and were not routinely fasted. However, data are limited, and further research is needed.

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.

Effect of telehealth-integrated antenatal care on pregnancy outcomes in Australia: an interrupted time-series analysis.

BACKGROUND: During the COVID-19 pandemic, rapid integration of telehealth into antenatal care occurred to support ongoing maternity care. A programme of this scale had not been previously implemented. We evaluated whether telehealth-integrated antenatal care in an Australian public health system could achieve pregnancy outcomes comparable to those of conventional care to assess its safety and efficacy. METHODS: Routinely collected data for individuals who gave birth at Monash Health (Melbourne, VIC, Australia) during a conventional care period (Jan 1, 2018, to March 22, 2020) and telehealth-integrated period (April 20, 2020, to April 25, 2021) were analysed. We included all births that occurred at 20 weeks' gestation or later or with a birthweight of at least 400 g (if duration of gestation was unknown). We excluded multiple births, births for which private antenatal care was received, and births to individuals transferred from other hospitals or who had no antenatal care. Baseline demographics, telehealth uptake, and pregnancy complications (related to pre-eclampsia, fetal growth restriction [FGR], gestational diabetes, stillbirth, neonatal intensive care [NICU] admission, and preterm birth [<37 weeks' gestation]) were compared using comparative statistics and an interrupted time-series analysis. Results were stratified by care stream, with high-risk models consisting of obstetric specialist-led care, and all other streams categorised as low-risk models. The impact of the integrated period on outcomes was also assessed with stratification by parity. FINDINGS: 17 873 births occurred in the conventional period and 8131 in the integrated period. Compared with the conventional period, women giving birth during the integrated period were slightly older (30·63 years vs 30·88 years) and had slightly higher BMI (25·52 kg/m2vs 26·14 kg/m2), and more Australian-born women gave birth during the integrated period (37·37% vs 39·79%). There were no significant differences in smoking status or parity between the two groups. 107 (0·08%) of 129 514 antenatal consultations in the conventional period and 34 444 (45·94%) of 74 982 in the integrated period were delivered by telehealth. No significant differences between the conventional and integrated periods were seen in median gestational age at pre-eclampsia diagnosis (low-risk models 37·4 weeks in the conventional period vs 37·1 weeks in the integrated period, difference -0·3 weeks [-0·7 to 0·1]; high-risk models 35·5 weeks vs 36·3 weeks, difference 0·3 weeks [-0·3 to 1·1]), incidence of FGR below the 3rd birthweight percentile (low-risk models 1·62% vs 1·74%, difference 0·12 percentage points [-0·26 to 0·50]; high-risk 4·04% vs 4·13%, difference 0·089 percentage points [-1·08 to 1·26]), and incidence of preterm birth (low-risk models 4·99% vs 5·01%, difference 0·02% [-0·62 to 0·66]; high-risk models 15·76% vs 14·43%, difference -1·33% [-3·42 to 0·77]). Parity did not affect these findings. Interrupted time-series analysis showed a significant reduction in induction of labour for singletons with suspected FGR among women in low-risk models during the integrated period (-0·04% change per week [95% CI -0·07 to -0·01], p=0·0040), and NICU admission declined after telehealth integration (low-risk models -0·02% change per week [-0·03 to -0·003], p=0·018; high-risk models -0·10% change per week, -0·19 to -0·001; p=0·047). No significant differences in stillbirth rates were observed. The proportion of women diagnosed with gestational diabetes was significantly higher in the integrated period compared with the conventional period for both low-risk care models (22·28% vs 25·13%, difference 2·85 percentage points [1·60 to 4·11]) and high-risk care models (28·70% vs 34·02%, difference 5·32 percentage points [2·57 to 8·07]). However overall, when compared with the conventional period, there was no significant difference in proportion of women with gestational diabetes requiring insulin therapy (low-risk models 8·08% vs 7·73%, difference -0·35 percentage points [-1·13 vs 0·44]; high-risk models 14·81% vs 15·71%, difference 0·89 percentage points [-1·23 to 3·02]), or proportion of women with gestational diabetes who gave birth to a baby with macrosomia in the integrated period (low-risk models 3·16% vs 2·33%, difference -0·83 percentage points [-1·77 to 0·12]; high-risk models 5·58% vs 4·81%, difference -0·77 percentage points [-3·06 to 1·52]). INTERPRETATION: Telehealth-integrated antenatal care replaced around 46% of in-person consultations without compromising pregnancy outcomes. It might be associated with a reduction in labour induction for suspected FGR, particularly for women in low-risk models, without compromising FGR detection or perinatal morbidity. These findings support the ongoing use of telehealth in providing flexible antenatal care. FUNDING: None.

Endometrial Origins of Stillbirth (EOS), a case-control study of menstrual fluid to understand and prevent preterm stillbirth and associated adverse pregnancy outcomes: study protocol.

INTRODUCTION: Current research aimed at understanding and preventing stillbirth focuses almost exclusively on the role of the placenta. The underlying origins of poor placental function leading to stillbirth, however, remain poorly understood. There is evidence demonstrating that the endometrial environment in which the embryo implants impacts not only the establishment of pregnancy but also the development of some pregnancy outcomes. Menstrual fluid has recently been applied to the study of menstrual disorders such as heavy menstrual bleeding or endometriosis, however, it has great potential in the study of adverse pregnancy outcomes. This study aims to identify differences in menstrual fluid and menstrual cycle characteristics of women who have experienced preterm stillbirth and other associated adverse pregnancy outcomes, compared with those who have not. The association between menstrual fluid composition and menstrual cycle characteristics will also be determined. METHODS AND ANALYSIS: This is a case-control study of women who have experienced a late miscarriage, spontaneous preterm birth or preterm stillbirth or a pregnancy complicated by placental insufficiency (fetal growth restriction or pre-eclampsia), compared with those who have had a healthy term birth. Cases will be matched for maternal age, body mass index and gravidity. Participants will not currently be on hormonal therapy. Women will be provided with a menstrual cup and will collect their sample on day 2 of menstruation. Primary exposure measures include morphological and functional differences in decidualisation of the endometrium (cell types, immune cell subpopulations and protein composition secreted from the decidualised endometrium). Women will complete a menstrual history survey to capture menstrual cycle length, regularity, level of pain and heaviness of flow. ETHICS AND DISSEMINATION: Ethics approval was obtained from Monash University Human Research Ethics Committee (27900) on 14/07/2021 and will be conducted in accordance with these conditions. Findings from this study will be disseminated through peer-reviewed publications and conference presentations.

Fetal surveillance from 39 weeks' gestation to reduce stillbirth in South Asian-born women.

BACKGROUND: In July 2017, the State of Victoria's largest maternity service implemented a new clinical guideline to reduce the rates of stillbirth at term for South Asian women. OBJECTIVE: This study aimed to evaluate the impact of offering fetal surveillance from 39 weeks to South Asian-born women on rates of stillbirth and neonatal and obstetrical interventions. STUDY DESIGN: This was a cohort study of all women receiving antenatal care at 3 large metropolitan university-affiliated teaching hospitals in Victoria, who gave birth in the term period between January 2016 and December 2020. Differences in rates of stillbirth, neonatal deaths, perinatal morbidities, and interventions after July 2017 were determined. Multigroup interrupted time-series analysis was used to assess changes in rates of stillbirth and induction of labor. RESULTS: A total of 3506 South Asian-born women gave birth before, and 8532 after the change in practice. There was a 64% reduction in term stillbirth (95% confidence interval, 87% to 2%; P=.047) after the change in practice from 2.3 per 1000 births to 0.8 per 1000 births. The rates of early neonatal death (3.1/1000 vs 1.3/1000; P=.03) and special care nursery admission (16.5% vs 11.1%; P<.001) also decreased. There were no significant differences in admission to the neonatal intensive care unit, 5-minute Apgar score <7, or birthweight, or differences in the trends of induction of labor per month. CONCLUSION: Fetal monitoring from 39 weeks may offer an alternative to routine earlier induction of labor to reduce the rates of stillbirth without causing an increase in neonatal morbidity and attenuating trends in obstetrical interventions.

Mechanical methods for induction of labour.

BACKGROUND: Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012. OBJECTIVES: To determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low-dose misoprostol (oral and vaginal), amniotomy or oxytocin. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review. SELECTION CRITERIA: Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods. Mechanical methods include: (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space (EASI). This review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: This review includes a total of 112 trials, with 104 studies contributing data (22,055 women; 21 comparisons). Risk of bias of trials varied. Overall, the evidence was graded from very-low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.   Balloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; low-quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate-quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate-quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate-quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five-minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively. Balloon versus low-dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low-quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate-quality evidence) but may increase the risk of a caesarean section (RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low-quality evidence, and five-minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low-quality evidence. Balloon versus low-dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate-quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low-quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low-quality evidence, five-minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low-quality evidence. AUTHORS' CONCLUSIONS: Low- to moderate-quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted. Moderate-quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low-dose vaginal misoprostol, low-quality evidence shows a balloon may be less effective, but probably has a better safety profile. Future research could be focused more on safety aspects for the neonate and maternal satisfaction.

South-Asian women's experiences of earlier additional, fetal monitoring to reduce stillbirth: An exploratory qualitative study.

BACKGROUND: In an attempt to reduce the rates of stillbirth at term among South-Asian born women, Victoria's largest maternity service, Monash Health, implemented a new clinical guideline in 2017 that recommended additional earlier, twice weekly monitoring to assess fetal wellbeing from 39 weeks for South-Asian women. In acknowledging the importance of woman centred, culturally responsive care, this study aimed to understand South-Asian women's, experiences, of the additional earlier fetal monitoring. METHODS: An exploratory qualitative study was conducted using semi-structured phone interviews six weeks postpartum, across June and July 2021, with South-Asian born women who underwent the earlier monitoring from 39 weeks. Women were asked questions regarding their understanding of the monitoring, their experiences of the monitoring process and any impact the monitoring or results had on their pregnancy, labour and birth. Interviews were recorded and transcribed verbatim. Data were analysed using a thematic approach and an inductive coding strategy. RESULTS: Seventeen women from India, Sri Lanka, Pakistan and Afghanistan were interviewed. the main themes were i: gaining peace of mind, need for better communication, did the women really have a choice? and comparisons to maternity care in the country of origin. Women experienced positive reassurance of their baby's well-being from the monitoring and were happy with the earlier, extra care. However, women described receiving variable explanations of the purpose of the monitoring. Ineffective communication and logistical barriers were highlighted to negatively impact women's ability to engage in shared decision making and their overall experience of the earlier monitoring. CONCLUSIONS: The additional monitoring is reported by these women to have an overall positive impact on their maternity care. Future work should explore the experiences of non-English speaking South-Asian women and those who declined monitoring.

Virtual reality and its use in post-operative pain following laparoscopy: a feasibility study.

Pain following laparoscopic surgery remains a neglected healthcare issue. Virtual reality-mediated therapy's (VRT) analgesic potential could address this. However, its effect in this setting remains unexplored. We aimed to establish the feasibility and safety of VRT as an adjunct analgesic following gynaecological laparoscopy and explore differences between active distraction and passive meditation content. 35 women were enrolled into an open crossover pilot and randomised to either intervention group 1 (active then passive content) or intervention group 2 (passive then active content) following surgery. VRT was administered in two 10-min segments with a 10-min washout period in between. Pain scores, opioid requirements and side effects were recorded before and after each segment whilst questionnaires evaluated acceptability. We observed a significant reduction in pain over time for the entire study population (F = 8.63, p < 0.0005) but no differences between intervention groups, in contrast to many studies demonstrating an increase in pain during this time. During segment one, intervention group 1 (n = 18) were administered significantly less opioid than intervention group 2 (n = 17) [0.0 (0.0-7.5) vs. 3.0(0.0-10.0), p = 0.04]. Intervention group 1 rated the VRT experience significantly higher than intervention group 2 (7.97 vs. 6.62. p = 0.017). 97.1% (n = 34) would recommend VRT to a friend and use it as the standard-of-care in future procedures. These results demonstrate that post-operative VRT is feasible and safe. However, adequately powered studies are needed to appropriately determine its efficacy.

The association between intrapartum interventions and immediate and ongoing breastfeeding outcomes: an Australian retrospective population-based cohort study.

BACKGROUND: The use of intrapartum interventions is becoming increasingly common globally. Interventions during birth, including caesarean section (CS), epidural analgesia and synthetic oxytocin infusion, can be important in optimizing obstetric care, but have the potential to impact breastfeeding. This study aimed to identify whether women who have certain intrapartum interventions have greater odds of unfavourable breastfeeding outcomes, both the immediate post-partum period and in the months after birth. METHODS: This was a population-based cohort study of singleton livebirths at ≥37 weeks' gestation between 2010 and 2018 in Victoria, Australia using routinely-collected state-wide data from the Victorian Perinatal Data Collection (VPDC) and the Child Development Information System (CDIS). The interventions included were pre-labour CS, in-labour CS, epidural analgesia, and synthetic oxytocin infusion (augmentation and/or induction of labour). Outcomes were formula supplementation in hospital, method of last feed before hospital discharge and breastfeeding status at 3-months and 6-months. Descriptive statistics and multivariable logistic regression models adjusting for potential confounders were employed. RESULTS: In total, 599,191 women initiated breastfeeding. In-labour CS (aOR 1.96, 95%CI 1.93,1.99), pre-labour CS (aOR 1.75, 95%CI 1.72,1.77), epidural analgesia (aOR 1.45, 95%CI 1.43,1.47) and synthetic oxytocin infusion (aOR 1.24, 95%CI 1.22,1.26) increased the odds of formula supplementation in hospital. Long-term breastfeeding data was available for 105,599 infants. In-labour CS (aOR 0.79, 95%CI 0.76,0.83), pre-labour CS (aOR 0.73, 95%CI 0.71,0.76), epidural analgesia (aOR 0.77, 95%CI 0.75,0.80) and synthetic oxytocin infusion (aOR 0.89, 95%CI 0.86-0.92) decreased the odds of exclusive breastfeeding at 3-months post-partum, which was similar at 6-months. There was a dose-response effect between number of interventions received and odds of each unfavourable breastfeeding outcome. CONCLUSION: Common intrapartum interventions are associated with less favourable breastfeeding outcomes, both in hospital and in the months after birth. This confirms the importance of only undertaking interventions when necessary. When interventions are used intrapartum, an assessment and identification of women at increased risk of early discontinuation of breastfeeding has to be performed. Targeted breastfeeding support for women who have intrapartum interventions, when they wish to breastfeed, is important.

Influence of Maternal Region of Birth on Placental Pathology of Babies Born Small.

BACKGROUND: Placental pathology is a common antecedent factor in infants born small for gestational age. Maternal region of birth can influence rates of SGA. AIMS: To determine the association of maternal region of birth on placental pathology in babies that are born small, comparing a South Asian born population with Australia and New Zealand born women. MATERIALS AND METHODS: A retrospective cohort study was conducted at Monash Health, the largest public health service in Victoria. Mother-baby pairs above 34 weeks' gestation and birth weight less than 10th centile born in 2016 were included. Placental pathology reports and medical records were reviewed. Statistical analyses of placental and selected neonatal outcomes data were performed. RESULTS: Three hundred and eleven small for gestational age babies were included in this study, of which 171 were born to South Asian mothers and 140 to Australian and New Zealand mothers. There were no significant differences in gestational age at birth between the groups (38.7 (1.6) vs. 38.3 (1.7) weeks, p = 0.06). Placental pathology (macroscopic and microscopic) data comparisons showed no significant differences between the two groups (81% major abnormality in both groups). This was despite South Asian small for gestational age babies being less likely to require admission to a special care nursery or neonatal intensive care unit (35 vs. 41%, p = 0.05), or have a major congenital abnormality (2.3 vs. 4.3%, p = 0.04). CONCLUSION: In this observational study, maternal region of birth did not have an influence on placental pathology of babies born small, despite some differences in neonatal outcomes.

Causes of perinatal deaths in Australia: Slow progress in the preterm period.

AIM: The majority of perinatal deaths occur in the preterm period; however, current approaches predominantly focus on prevention in the term period. Reducing perinatal deaths in the preterm period is, therefore, key to reducing the rates of perinatal death overall in Australia. The aim was to understand the classifications of causes of preterm stillbirth and neonatal death in Victoria over time and by gestation. MATERIALS AND METHODS: Retrospective study using state-wide, publicly available data. All births in Victoria between 2010 and 2018 included in the Victorian Perinatal Data Collection, excluding terminations of pregnancy for maternal psychosocial indications, were studied. Differences in causes of preterm perinatal mortality gestation group and over time were determined. RESULTS: Out of 7977 perinatal deaths reported, 85.9% (n = 6849) were in the preterm period. The most common cause of preterm stillbirths was congenital anomalies (n = 1574, 29.8%), followed by unexplained antepartum deaths (n = 557, 14.2%). The most common cause of preterm neonatal death was spontaneous preterm birth (sPTB; n = 599, 38.2%), followed by congenital anomalies (n = 493, 31.4%). The rate of preterm stillbirths due to hypertension (-14.9% (95% CI -27.1% to -2.7%; P = 0.02)), maternal conditions (-24.1% (95% CI -44.2% to -4.0%; P = 0.03)) and those that were unexplained (-5.4% (95% CI -9.8% to -1.2%; P = 0.02)) decreased per annum between 2010 and 2018. All other classifications did not change significantly over time. CONCLUSION: Prevention of congenital anomalies and sPTB is critical to reducing preterm perinatal mortality. Greater emphasis on understanding causes of preterm deaths through mortality investigations may reduce the proportion of those considered 'unexplained'.

Vaginal pressure sensor measurement during maximal voluntary pelvic floor contraction correlates with vaginal birth and pelvic organ prolapse-A pilot study.

AIMS: To measure the force applied along the anterior and posterior vaginal walls in a cohort of 46 patients measured by a fiber-optic pressure sensor and determine if this correlates with vaginal parity and pelvic organ prolapse (POP). METHODS: An intravaginal fiber-optic sensor measured pressure at nine locations along the anterior and posterior vaginal walls during a maximal voluntary pelvic floor muscle contraction (MVC). An automated probe dilation cycle measured the tissue resistance incorporating the vagina and surrounding anatomy. MVC and resting tissue resistance (RTR) were assessed between subjects grouped by the number of vaginal births and prolapse stage. RESULTS: A previous vaginal birth was associated with a significant threefold decrease in the overall anterior pressure measurement during MVC. Decreased anterior pressure measurements were observed at Sensors 1 and 3 (distal vagina) and, posteriorly at Sensors 4-6 (midvagina). Women with Stage 2 posterior prolapse exhibited a decreased MVC pressure in the midvagina than those with Stage 0/1. In this pilot study, there was no difference in the vaginal wall RTR according to previous vaginal birth or stage of prolapse. CONCLUSION: This pilot study found that a decrease in vaginal pressure measured during MVC is associated with vaginal birth and with posterior POP. Greater sample size is required to assess the role of resting tissue pressure measurement.

Where do low risk women live relative to maternity services across Victoria? Expanding access to public homebirth models across Victoria.

PROBLEM: Currently <1% of Australian women give birth at home. BACKGROUND: In Australia there are very few options for women to access public funded homebirth. AIM: We aimed to use geo-mapping to identify the number of women eligible for homebirth in Victoria, based on the criteria of uncomplicated pregnancies and residing within 15-25kms of suitable maternity services, to plan future maternity care options. METHODS: Retrospective study of births between 2015 and 2017 in Victoria, Australia. All women who were identified as having a low risk pregnancy at the beginning of pregnancy were included. The number of women within 15 and 25km of a suitable Victorian public maternity hospital and catchment boundaries around each hospital were determined. FINDINGS: Between 2015 and 2017, 126,830 low risk women gave birth in Victoria, of whom half live within 25km of seven Victorian hospitals. Currently, 2% of suitable women who live close to the current public homebirth models accessed them. DISCUSSION: We present a method to inform the expansion of maternity service options using Victoria as an example. On the basis of the maximum number of low risk women living close by, we have also identified the Victorian maternity services that would be most suitable for creation of public homebirth or low risk continuity of midwifery models. CONCLUSION: This approach could can be used to plan other maternity care services.

Fetal monitoring from 39 weeks' gestation to identify South Asian-born women at risk of perinatal compromise: a retrospective cohort study.

To investigate whether earlier "post-term" monitoring of South Asian (SA) pregnancies from 39 weeks' gestation with amniotic fluid index (AFI) and cardiotocography (CTG) detected suspected fetal compromise. Retrospective cohort study of all SA-born women at an Australian health service with uncomplicated, singleton pregnancies following the introduction of twice-weekly AFI and CTG monitoring from 39 weeks. Monitoring results, and their association with a perinatal compromise composite (including assisted delivery for fetal compromise, stillbirth, and NICU admission) were determined. 771 SA-born women had earlier monitoring, triggering delivery in 82 (10.6%). 31 (4%) had a non-reassuring antepartum CTG (abnormal fetal heart rate or variability, or decelerations) and 21 (2.7%) had an abnormal AFI (≤ 5 cm). Women with abnormal monitoring were 53% (95% CI 1.2-1.9) more likely to experience perinatal compromise and 83% (95% CI 1.2-2.9) more likely to experience intrapartum compromise than women with normal monitoring. Monitoring from 39 weeks identified possible fetal compromise earlier than it otherwise would have been, and triggered intervention in 10% of women. Without robust evidence to guide timing of birth in SA-born women to reduce rates of stillbirth, earlier monitoring provides an alternative to routine induction of labour.

Widespread implementation of a low-cost telehealth service in the delivery of antenatal care during the COVID-19 pandemic: an interrupted time-series analysis.

BACKGROUND: Little evidence is available on the use of telehealth for antenatal care. In response to the COVID-19 pandemic, we developed and implemented a new antenatal care schedule integrating telehealth across all models of pregnancy care. To inform this clinical initiative, we aimed to assess the effectiveness and safety of telehealth in antenatal care. METHODS: We analysed routinely collected health data on all women giving birth at Monash Health, a large health service in Victoria (Australia), using an interrupted time-series design. We assessed the impact of telehealth integration into antenatal care from March 23, 2020, across low-risk and high-risk care models. Allowing a 1-month implementation period from March 23, 2020, we compared the first 3 months of telehealth integrated care delivered between April 20 and July 26, 2020, with conventional care delivered between Jan 1, 2018, and March 22, 2020. The primary outcomes were detection and outcomes of fetal growth restriction, pre-eclampsia, and gestational diabetes. Secondary outcomes were stillbirth, neonatal intensive care unit admission, and preterm birth (birth before 37 weeks' gestation). FINDINGS: Between Jan 1, 2018, and March 22, 2020, 20 031 women gave birth at Monash Health during the conventional care period and 2292 women gave birth during the telehealth integrated care period. Of 20 154 antenatal consultations provided in the integrated care period, 10 731 (53%) were delivered via telehealth. Overall, compared with the conventional care period, no significant differences were identified in the integrated care period with regard to the number of babies with fetal growth restriction (birthweight below the 3rd percentile; 2% in the integrated care period vs 2% in the conventional care period, p=0·72, for low-risk care models; 5% in the integrated care period vs 5% in the conventional care period, p=0·50 for high-risk care models), number of stillbirths (1% vs 1%, p=0·79; 2% vs 2%, p=0·70), or pregnancies complicated by pre-eclampsia (3% vs 3%, p=0·70; 9% vs 7%, p=0·15), or gestational diabetes (22% vs 22%, p=0·89; 30% vs 26%, p=0·06). Interrupted time-series analysis showed a significant reduction in preterm birth among women in high-risk models (-0·68% change in incidence per week [95% CI -1·37 to -0·002]; p=0·049), but no significant differences were identified in other outcome measures for low-risk or high-risk care models after telehealth integration compared with conventional care. INTERPRETATION: Telehealth integrated antenatal care enabled the reduction of in-person consultations by 50% without compromising pregnancy outcomes. This care model can help to minimise in-person interactions during the COVID-19 pandemic, but should also be considered in post-pandemic health-care models. FUNDING: None.

Preventing critical failure. Can routinely collected data be repurposed to predict avoidable patient harm? A quantitative descriptive study.

OBJECTIVES: To determine whether sharing of routinely collected health service performance data could have predicted a critical safety failure at an Australian maternity service. DESIGN: Observational quantitative descriptive study. SETTING: A public hospital maternity service in Victoria, Australia. DATA SOURCES: A 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 MEASURES: Numbers and rates for events (activity, deaths, complaints, litigation, practitioner notifications). Correlation coefficients. RESULTS: Between 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. CONCLUSION: While 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.