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This systematic review and meta-analysis synthesised the post-1990 literature examining the effect of human milk on morbidity, specifically necrotising enterocolitis (NEC), late onset sepsis (LOS), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) and neurodevelopment in infants born ≤28 weeks' gestation and/or publications with reported infant mean birth weight of ≤1500 g. Online databases including Medline, PubMed, CINAHL, Scopus, and the Cochrane Central Register of Controlled Trials were searched, and comparisons were grouped as follows: exclusive human milk (EHM) versus exclusive preterm formula (EPTF), any human milk (HM) versus EPTF, higher versus lower dose HM, and unpasteurised versus pasteurised HM. Experimental and observational studies were pooled separately in meta-analyses. Risk of bias was assessed for each individual study and the GRADE system used to judge the certainty of the findings. Forty-nine studies (with 56 reports) were included, of which 44 could be included in meta-analyses. HM provided a clear protective effect against NEC, with an approximate 4% reduction in incidence. HM also provided a possible reduction in LOS, severe ROP and severe NEC. Particularly for NEC, any volume of HM is better than EPTF, and the higher the dose the greater the protection. Evidence regarding pasteurisation is inconclusive, but it appears to have no effect on some outcomes. Improving the intake of mother's own milk (MOM) and/or donor HM results in small improvements in morbidity in this population.

Background: Babies born preterm are at an increased risk of dying in the first weeks of life, and those who survive have a higher rate of cerebral palsy (CP) compared with babies born at term. The aim of this individual participant data (IPD) meta-analysis (MA) was to assess the effects of antenatal magnesium sulphate, compared with no magnesium treatment, given to women at risk of preterm birth on important maternal and fetal outcomes, including survival free of CP, and whether effects differed by participant or treatment characteristics such as the reason the woman was at risk of preterm birth, why treatment was given, the gestational age at which magnesium sulphate treatment was received, or the dose and timing of the administration of magnesium sulphate., Methods and Findings: Trials in which women considered at risk of preterm birth (<37 weeks' gestation) were randomised to magnesium sulphate or control treatment and where neurologic outcomes for the baby were reported were eligible for inclusion. The primary outcomes were infant death or CP and severe maternal outcome potentially related to treatment. Studies were identified based on the Cochrane Pregnancy and Childbirth search strategy using the terms [antenatal or prenatal] and [magnesium] and [preterm or premature or neuroprotection or 'cerebral palsy']. The date of the last search was 28 February 2017. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. For each prespecified outcome, IPD were analysed using a 1-stage approach. All 5 trials identified were included, with 5,493 women and 6,131 babies. Overall, there was no clear effect of magnesium sulphate treatment compared with no treatment on the primary infant composite outcome of death or CP (relative risk [RR] 0.94, 95% confidence interval (CI) 0.85 to 1.05, 6,131 babies, 5 trials, p = 0.07 for heterogeneity of treatment effect across trials). In the prespecified sensitivity analysis restricted to data from the 4 trials in which the intent of treatment was fetal neuroprotection, there was a significant reduction in the risk of death or CP with magnesium sulphate treatment compared with no treatment (RR 0.86, 95% CI 0.75 to 0.99, 4,448 babies, 4 trials), with no significant heterogeneity (p = 0.28). The number needed to treat (NNT) to benefit was 41 women/babies to prevent 1 baby from either dying or having CP. For the primary outcome of severe maternal outcome potentially related to magnesium sulphate treatment, no events were recorded from the 2 trials providing data. When the individual components of the composite infant outcome were assessed, no effect was seen for death overall (RR 1.03, 95% CI 0.91 to 1.17, 6,131 babies, 5 trials) or in the analysis of death using only data from trials with the intent of fetal neuroprotection (RR 0.95, 95% CI 0.80 to 1.13, 4,448 babies, 4 trials). For cerebral palsy in survivors, magnesium sulphate treatment had a strong protective effect in both the overall analysis (RR 0.68, 95% CI 0.54 to 0.87, 4,601 babies, 5 trials, NNT to benefit 46) and the neuroprotective intent analysis (RR 0.68, 95% CI 0.53 to 0.87, 3,988 babies, 4 trials, NNT to benefit 42). No statistically significant differences were seen for any of the other secondary outcomes. The treatment effect varied little by the reason the woman was at risk of preterm birth, the gestational age at which magnesium sulphate treatment was given, the total dose received, or whether maintenance therapy was used. A limitation of the study was that not all trials could provide the data required for the planned analyses so that combined with low event rates for some important clinical events, the power to find a difference was limited., Conclusions: Antenatal magnesium sulphate given prior to preterm birth for fetal neuroprotection prevents CP and reduces the combined risk of fetal/infant death or CP. Benefit is seen regardless of the reason for preterm birth, with similar effects across a range of preterm gestational ages and different treatment regimens. Widespread adoption worldwide of this relatively inexpensive, easy-to-administer treatment would lead to important global health benefits for infants born preterm.

Objective: To compare the health and economic impacts of implementing efficacious treatment interventions with maintaining standard practice in maternal and perinatal health care., Design and Setting: We identified randomised clinical trials (RCTs) in the Perinatal Society of Australia and New Zealand trials database that commenced recruitment during 2008 and had completed recruitment by 2015. Data from clinical trial registries and publications were collated to calculate the potential cost savings achievable by implementing efficacious treatment interventions., Main Outcome Measure: Projected net cost savings over 5 years., Results: Twenty-three eligible RCTs covering a range of behavioural and clinical interventions were identified, of which six reported interventions superior to standard practice (four trials) or placebo (two). The outcomes (but not the costs) of 17 trials were excluded from analysis (no difference between intervention and comparator groups in seven trials, recruitment problems in six, findings not yet published in four). The total funding amount for the 23 trials was $20.3 million; the potential cost savings over 5 years if the findings of the six trials reporting superior interventions were implemented was estimated to be $26.3 million if 10% of the eligible populations received the effective interventions, and $262.8 million with 100% implementation., Conclusions: Our retrospective analysis highlights the value of research in perinatal care and the importance of implementing positive findings for realising its value. Future trials in maternal and perinatal health care may provide significant returns on investment by informing clinical practice, improving patient outcomes and reducing health care costs.

Background: Perinatal morbidity and mortality remain significant public health issues globally, with enduring impact on the health and well-being of women and their families. Pregnant women who adopt, practice and maintain healthy behaviours can potentially improve the health of themselves and their babies. Mobile applications are an increasingly popular mode of accessing, storing and sharing health information among pregnant women. The main objective of this review is to evaluate the effects of mobile application interventions during pregnancy on maternal behaviour and associated maternal and infant outcomes., Methods: This review will include randomised and non-randomised studies which tested use of mobile applications designed to improve either maternal knowledge or behaviours to address known risk factors associated with adverse perinatal health outcomes. This review will include studies which included pregnant women and/or women during birth. The search strategy will utilise a combination of keywords and MeSH terms. Literature databases such as PubMed, Embase, The Cochrane Library, CINAHL and WHO Global Health Library will be searched. Two reviewers will independently screen retrieved citations to determine if they meet inclusion criteria. Studies will be selected that provide information about interventions commenced in early pregnancy, late pregnancy or labour. Comparisons to be made include mobile applications versus interventions relying on paper-based or text-messaging-based communication; interpersonal communication such as face-to-face or telephone conversation; and no intervention or standard care. Quality assessment of included randomised studies will utilise established guidelines provided in the Cochrane Handbook for Systematic Reviews of Interventions. Quality assessment of non-randomised studies will be based on the Risk of Bias in Non-randomised Studies-of Interventions (ROBINS-I) assessment tool. Quality of the evidence will be evaluated using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Separate comparisons and analyses for primary and secondary outcomes will be performed. Results of the review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines., Discussion: This systematic review will identify and synthesize evidence about the effect of interventions delivered through mobile applications on influencing maternal behaviour and improving perinatal health outcomes., Systematic Review Registration: PROSPERO CRD42016037344 .

Background: Aboriginal and Torres Strait Islander women, hereafter called Indigenous women, can experience a lack of understanding of their cultural needs when accessing maternity care in the standard hospital care system., Aim: To explore the lived experiences described by Indigenous women accessing labour and birth care in the standard hospital care system at a tertiary public hospital in South Australia., Methods: An interpretive Heideggerian phenomenological approach was used. Indigenous women who accessed standard care voluntarily agreed to participate in semi-structured interviews with Indigenous interviewers. The interviews were transcribed and analysed informed by van Manen's approach., Findings: Thematic analysis revealed six main themes: "knowing what is best and wanting the best for my baby", "communicating my way", "how they made me feel", "all of my physical needs were met", "we have resilience and strength despite our hardships" and "recognising my culture"., Conclusion: Indigenous women in this study expressed and shared some of their cultural needs, identifying culturally unsafe practices. Recommendations to address these include the extension of current care planners to include cultural needs; Aboriginal Maternal Infant Care (AMIC) workers for women from rural and remote areas; AMIC workers on call to assist the women and midwives; increased education, employment and retention of Indigenous midwives; increased review into the women's experiences; removal of signs on the door restricting visitors in the birth suite; flexibility in the application of hospital rules and regulations; and changes to birthing services in rural and remote areas so women may not have to relocate for birth., (Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Background: Lack of appropriate health care seeking for ill mothers and neonates contributes to high mortality rates. A major challenge is the appropriate mix of strategies for creating demand as well as provision of services., Design: Systematic review and meta-analysis of experimental studies (last search: Jan 2015) to assess the impact of different strategies to improve maternal and neonatal health care seeking in low- and middle-income countries (LMIC)., Results: Fifty-eight experimental [randomized controlled trials (RCTs), non-RCTs, and before-after studies] with 310,652 participants met the inclusion criteria. Meta-analyses from 29 RCTs with a range of different interventions (e.g. mobilization, home visitation) indicated significant improvement in health care seeking for neonatal illnesses when compared with standard/no care [risk ratio (RR) 1.40; 95 confidence interval (CI): 1.17-1.68, 9 studies, n=30,572], whereas, no impact was seen on health care seeking for maternal illnesses (RR 1.06; 95% CI: 0.92-1.22, 5 studies, n=15,828). These interventions had a significant impact on reducing stillbirths (RR 0.82; 95% CI: 0.73-0.93, 11 studies, n=176,683), perinatal deaths (RR 0.84; 95% CI: 0.77-0.90, 15 studies, n=279,618), and neonatal mortality (RR 0.80; 95% CI: 0.72-0.89, 20 studies, n=248,848). On GRADE approach, evidence was high quality except for the outcome of maternal health care seeking, which was moderate., Conclusions: Community-based interventions integrating strategies such as home visiting and counseling can help to reduce fetal and neonatal mortality in LMIC.

Background: Aboriginal and Torres Strait islander(1) women face considerable health disparity in relation to their maternity health outcomes when compared to non-Aboriginal women. Culture and culturally appropriate care can contribute to positive health outcomes for Aboriginal women. How midwives provide culturally appropriate care and how the care is experienced by the women is central to this study., Aim: To explore the lived experiences of midwives providing care in the standard hospital care system to Aboriginal women at a large tertiary teaching hospital., Methods: An interpretive Heideggerian phenomenological approach was used. Semi-structured interviews were conducted with thirteen volunteer midwives which were transcribed, analysed and presented informed by van Manen's approach., Findings: Thematic analysis revealed six main themes: "Finding ways to connect with the women", "building support networks - supporting with and through Aboriginal cultural knowledge", "managing the perceived barriers to effective care", "perceived equity is treating women the same", "understanding culture" and "assessing cultural needs - urban versus rural/remote Aboriginal cultural needs"., Conclusion: The midwives in this study have shared their stories of caring for Aboriginal women. They have identified communication and building support with Aboriginal health workers and families as important. They have identified perceived barriers to the provision of care, and misunderstanding around the interpretation of cultural safety in practice was found. Suggestions are made to support midwives in their practice and improve the experiences for Aboriginal women., (Copyright © 2015 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Background: This study assessed the views of the women who participated in the DIAMIND randomised trial of postpartum SMS reminders to test for type 2 diabetes after gestational diabetes (GDM) on their preferred type of postpartum reminder system and barriers and facilitators to completion of postpartum diabetes testing., Method: A written questionnaire was sent to women with recent GDM who participated in the DIAMIND trial (n=276) via post or email at six months after the birth of their baby., Results: 208 women (75%) returned the study questionnaires. Preferred postpartum reminder types were: SMS (67%), email (17%), postal (12%) and voice call (1%). Women who had not yet completed an OGTT indicated that they planned to undertake one in the future (61%). Common barriers to postpartum OGTT completion included: not having enough time (73%), inadequate childcare (30%), and a need to focus on the health of the baby (30%). The most common facilitator was having a shorter test (33%)., Conclusions: Improved childcare quality and access as well as more research into a shorter, more convenient test procedure for type 2 diabetes screening are needed. Reminder systems for postpartum diabetes screening should be electronic where possible., (Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)

Background: The purpose of this study is to assess use of a booklet by pregnant women to record and assist dietary and lifestyle changes; to describe diet and exercise goals set during the initial lifestyle discussions; and to assess achievement of goals., Methods: Participants were women with borderline gestational diabetes who received a printed pregnancy record booklet, as part of a randomised trial, to record and set monthly goals for diet and exercise. Outcomes included women's use of the booklets and their achievement of dietary and exercise goals after 1 month., Results: Fifty-six women returned their used pregnancy record booklets and were included in this study. These women set a total of 197 dietary goals and 65 exercise goals. In the first month, over 80% of dietary goals that targeted grains, dairy and overall diet were achieved, but only 20-30% of goals about vegetables, and foods high in fat, sugar and/or salt were achieved. After 1 month, women had achieved 86.4% of their exercise goals to maintain their current level of activity, but only 25.0 % exercise goals to increase walking during pregnancy., Conclusions: Women who used pregnancy record booklets reported good achievement rates for goals related to grains, fruits, dairy and overall diet, but they were less likely to be successful in achieving goals to increase intake of vegetables, and limit foods that high in fat, sugar and/or salt. Maintaining an active lifestyle during pregnancy was feasible for women although increases in physical activity were less often achieved. Using a pregnancy record booklet may be helpful in assisting and encouraging behavioural changes, although further investigations of long-term effects and in different populations are warranted.

Aims: This parallel group randomized controlled trial assessed whether an SMS reminder system for women, after gestational diabetes, would increase their attendance for an oral glucose tolerance test (OGTT) by six months postpartum., Methods: Women were eligible for inclusion if they were diagnosed with gestational diabetes in their recent pregnancy, had a mobile phone and normal blood glucose profile prior to postnatal discharge from the Women's and Children's Hospital, Adelaide. A computer-generated random number sequence and telephone randomization were used. Two hundred and seventy-six women were randomized. Women in the six-week group (n = 140) were sent a text reminder to attend for an OGTT at six weeks postpartum, with further reminders at three and six months if required. Women in the control group (n = 136) received one text reminder at six months postpartum. Blinding was not feasible. The primary outcome was OGTT attendance within six months postpartum., Results: Women in the six-week group did not increase their attendance for an OGTT within six months postpartum compared with women in the control group, 104 (77.6% of 134) versus 103 (76.8% of 134), relative risk (RR) 1.01, 95% confidence interval (CI) 0.89-1.15., Conclusions: The SMS reminder system did not increase postpartum OGTT, fasting plasma glucose or HbA1c completion, although high rates of test completion were measured in both groups. Further research is required into factors influencing attendance for postpartum testing from the perspective of women, and into optimal counselling relating to Type 2 diabetes risk in the postpartum period for increasing postpartum glucose testing rates., (© 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.)

Background: Evidence-based interventions and strategies are needed to improve child survival in countries with a high burden of neonatal and child mortality. An overview of systematic reviews can focus implementation on the most effective ways to increase child survival., Methods: In this overview we included published Cochrane and other systematic reviews of experimental and observational studies on antenatal, childbirth, postnatal and child health interventions aiming to prevent perinatal/neonatal and child mortality using the WHO list of essential interventions. We assessed the methodological quality of the reviews using the AMSTAR criteria and assessed the quality of the outcomes using the GRADE approach. Based on the findings from GRADE criteria, interventions were summarized as effective, promising or ineffective., Findings: The overview identified 148 Cochrane and other systematic reviews on 61 reproductive, maternal, newborn and child health interventions. Of these, only 57 reviews reported mortality outcomes. Using the GRADE approach, antenatal corticosteroids for preventing neonatal respiratory distress syndrome in preterm infants; early initiation of breastfeeding; hygienic cord care; kangaroo care for preterm infants; provision and promotion of use of insecticide treated bed nets (ITNs) for children; and vitamin A supplementation for infants from six months of age, were identified as clearly effective interventions for reducing neonatal, infant or child mortality. Antenatal care, tetanus immunization in pregnancy, prophylactic antimalarials during pregnancy, induction of labour for prolonged pregnancy, case management of neonatal sepsis, meningitis and pneumonia, prophylactic and therapeutic use of surfactant, continuous positive airway pressure for neonatal resuscitation, case management of childhood malaria and pneumonia, vitamin A as part of treatment for measles associated pneumonia for children above 6 months, and home visits across the continuum of care, were identified as promising interventions for reducing neonatal, infant, child or perinatal mortality., Interpretation: Comprehensive adoption of the above six effective and 11 promising interventions can improve neonatal and child survival around the world. Choice of intervention and degree of implementation currently depends on resources available and policies in individual countries and geographical settings., Funding: This review was part of doctoral thesis which was funded by University of Adelaide, Australia.

Introduction: Little is known about women's views relating to a diagnosis of borderline gestational diabetes mellitus (GDM) and the subsequent management. This study aimed to explore women's experiences after being diagnosed with borderline GDM, their attitudes about treatment, and factors important to them for achieving any lifestyle changes., Methods: We conducted face-to-face, semistructured interviews with women diagnosed with borderline GDM., Results: A total of 22 women were interviewed. After a diagnosis of borderline GDM, 14 (64%) women reported not being concerned or worried. Management of borderline GDM was thought by 21 (95%) women to be very important or important. Eighteen (82%) women planned to improve their diet and/or exercise to manage their borderline GDM. The most frequently mentioned enabler for achieving intended lifestyle change was being more motivated to improve the health of their baby and/or themselves (15 women). The most frequent barrier was tiredness and/or being physically unwell (11 women)., Conclusions: A diagnosis of borderline GDM caused some concern to one-third of women interviewed. The majority of women believed managing their borderline GDM was important and they planned to improve their lifestyle. Women's own and their babies' future health were powerful motivators for lifestyle change.

Objectives: The aim of this study was to investigate the relationship between maternal diet during pregnancy and lactation and development of atopic disorders in childhood., Methods: We included studies published up to August 2011 that assessed food-based maternal dietary interventions or that examined associations between maternal dietary intake during pregnancy and/or lactation and allergic outcomes (eczema, asthma, hay fever, and sensitization) in their children., Results: We included 42 studies (>40 000 children): 11 intervention studies (including 7 randomized control trials), 26 prospective cohort studies, 4 retrospective cohort studies, and 1 case-control study. In the randomized control trials, no significant difference was noted overall in the prevalence of eczema and asthma in the offspring of women on diets free from common food allergens during pregnancy. The prospective cohorts investigated a large number of potential associations, but reported few significant associations between maternal dietary intake and development of allergy. Maternal diets rich in fruits and vegetables, fish, and foods containing vitamin D and Mediterranean dietary patterns were among the few consistent associations with lower risk for allergic disease in their children. Foods associated with higher risk included vegetable oils and margarine, nuts, and fast food., Conclusion: This review did not find widespread or consistent links between mothers' dietary intake and atopic outcomes in their children. However, maternal consumption of Mediterranean dietary patterns, diets rich in fruits and vegetables, fish, and vitamin D-containing foods were suggestive of benefit, requiring further evaluation., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To evaluate a slower (compared with a standard) infusion rate of the loading dose of magnesium sulphate for preterm fetal neuroprotection as a strategy to reduce maternal adverse effects., Design: Randomised controlled trial., Setting: South Australian maternity hospital., Population: Fifty-one women at <30 weeks of gestation, where birth was planned or expected within 24 hours., Methods: Women received a loading infusion of 4 g of magnesium sulphate over either 60 or 20 minutes (followed by maintenance of 1 g/hour until birth, or for up to 24 hours)., Main Outcome Measures: Any maternal adverse effects associated with the infusion., Results: Overall, 71% of women experienced adverse effects during the first hour of their infusion; the difference between groups was not significant [15/25 (60%) 60-minute loading; 21/26 (81%) 20-minute loading; risk ratio (RR) 0.74; 95% confidence interval (95% CI) 0.51-1.08]. Although no serious maternal complications occurred, adverse effects led to three women ceasing the loading treatment (1/25 in the 60-minute loading group; 2/26 in the 20-minute loading group; RR 0.52; 95% CI 0.05-5.38). Women in the 60-minute loading group experienced significantly less warmth and flushing at 20 minutes into the infusion (7/25 in the 60-minute loading group; 15/26 in the 20-minute loading group; RR 0.49; 95% CI 0.24-0.99). No other differences between groups for maternally reported and clinical adverse effects were shown., Conclusions: A slower rate of administering the loading dose of magnesium sulphate did not reduce the occurrence of maternal adverse effects overall. Flushing and warmth at 20 minutes into the infusion was reduced with a slower infusion., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Background: Babies born very preterm (before 30 weeks gestation) are at high risk of dying in their first weeks of life, and those who survive are at risk of developing cerebral palsy in childhood. Recent high-quality evidence has shown that giving women magnesium sulphate immediately prior to very early birth can significantly increase the chances of their babies surviving free of cerebral palsy. In 2010 Australian and New Zealand clinical practice guidelines recommended this therapy. The WISH (Working to Improve Survival and Health for babies born very preterm) Project aims to bi-nationally improve and monitor the use of this therapy to reduce the risk of very preterm babies dying or having cerebral palsy., Methods/design: The WISH Project is a prospective cohort study. The 25 Australian and New Zealand tertiary level maternity hospitals will be provided with a package of active implementation strategies to guide the introduction and local adaptation of guideline recommendations. Surveys will be conducted at individual hospitals to evaluate outcomes related to local implementation progress and the use and value of the WISH implementation strategies. For the hospitals participating in the 'WISH audit of uptake and health outcomes data collection', the primary health outcomes (assessed through case note review, and 24 month corrected age questionnaires) will be: the proportion of eligible women receiving antenatal magnesium sulphate; and rates of death prior to primary hospital discharge and cerebral palsy at two years corrected age in infants born to eligible mothers. For hospitals wishing to assess factors influencing translation locally, barriers and facilitators will be measured through interviews with health care professionals, to further guide implementation strategies. Study outcomes for the early phase of the project (Year 1) will be compared with the later intervention phase (Years 2 and 3)., Discussion: The WISH Project will offer insight into the effectiveness of a multifaceted implementation strategy to improve the uptake of a novel neuroprotective therapy in obstetric clinical practice. The successful implementation of antenatal magnesium sulphate for fetal neuroprotection in Australia and New Zealand could lead to over 90 fewer very preterm babies dying or suffering the long-term consequences of cerebral palsy each year.

Background: Antenatal magnesium sulphate, widely used in obstetrics to improve maternal and infant outcomes, may be associated with adverse effects for the mother sufficient for treatment cessation. This systematic review aimed to quantify maternal adverse effects attributed to treatment, assess how adverse effects vary according to different regimens, and explore women's experiences with this treatment., Methods: Bibliographic databases were searched from their inceptions to July 2012 for studies of any design that reported on maternal adverse effects associated with antenatal magnesium sulphate given to improve maternal or infant outcomes. Primary outcomes were life-threatening adverse effects of treatment (death, cardiac arrest, respiratory arrest). For randomised controlled trials, data were meta-analysed, and risk ratios (RR) pooled using fixed-effects or random-effects models. For non-randomised studies, data were tabulated by design, and presented as RR, odds ratios or percentages, and summarised narratively., Results: A total of 143 publications were included (21 randomised trials, 15 non-randomised comparative studies, 32 case series and 75 reports of individual cases), of mixed methodological quality. Compared with placebo or no treatment, magnesium sulphate was not associated with an increased risk of maternal death, cardiac arrest or respiratory arrest. Magnesium sulphate significantly increased the risk of 'any adverse effects' overall (RR 4.62, 95% CI 2.42-8.83; 4 trials, 13,322 women), and treatment cessation due to adverse effects (RR 2.77; 95% CI 2.32-3.30; 5 trials, 13,666 women). Few subgroup differences were observed (between indications for use and treatment regimens). In one trial, a lower dose regimen (2 g/3 hours) compared with a higher dose regimen (5 g/4 hours) significantly reduced treatment cessation (RR 0.05; 95% CI 0.01-0.39, 126 women). Adverse effect estimates from studies of other designs largely supported data from randomised trials. Case reports supported an association between iatrogenic overdose of magnesium sulphate and life-threatening consequences., Conclusions: Appropriate administration of antenatal magnesium sulphate was not shown to be associated with serious maternal adverse effects, though an increase in 'minor' adverse effects and treatment cessation was shown. Larger trials are needed to determine optimal regimens, achieving maximal effectiveness with minimal adverse effects, for each antenatal indication for use. Vigilance in the use of magnesium sulphate is essential for women's safety.

Background: Both dexamethasone and betamethasone, given to women at risk of preterm birth, substantially improve short-term neonatal health, increase the chance of the baby being discharged home alive, and reduce childhood neurosensory disability, remaining safe into adulthood. However, it is unclear which corticosteroid is of greater benefit to mother and child.This study aims to determine whether giving dexamethasone to women at risk of preterm birth at less than 34 weeks' gestation increases the chance of their children surviving free of neurosensory disability at two years' corrected age, compared with betamethasone., Methods/design: Design randomised, multicentre, placebo controlled trial.Inclusion criteria women at risk of preterm birth at less than 34 weeks' gestation with a singleton or twin pregnancy and no contraindications to the use of antenatal corticosteroids and who give informed consent.Trial entry & randomisation at telephone randomisation eligible women will be randomly allocated to either the dexamethasone group or the betamethasone group, allocated a study number and corresponding treatment pack.Study groups women in the dexamethasone group will be administered two syringes of 12 mg dexamethasone (dexamethasone sodium phosphate) and women in the betamethasone group will be administered two syringes of 11.4 mg betamethasone (Celestone Chronodose). Both study groups consist of intramuscular treatments 24 hours apart.Primary study outcome death or any neurosensory disability measured in children at two years' corrected age.Sample size a sample size of 1449 children is required to detect either a decrease in death or any neurosensory disability from 27.0% to 20.1% with dexamethasone compared with betamethasone, or an increase from 27.0% to 34.5% (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2)., Discussion: This study will provide high-level evidence of direct relevance for clinical practice. If one drug clearly results in significantly fewer deaths and fewer disabled children then it should be used consistently in women at risk of preterm birth and would be of great importance to women at risk of preterm birth, their children, health services and communities., Trial Registration Number: ACTRN12608000631303.

Background: Magnesium sulphate is currently recommended for neuroprotection of preterm infants for women at risk of preterm birth at less than 30 weeks' gestation, based on high quality evidence of benefit. However there remains uncertainty as to whether these benefits apply at higher gestational ages.The aim of this randomised controlled trial is to assess whether giving magnesium sulphate compared with placebo to women immediately prior to preterm birth between 30 and 34 weeks' gestation reduces the risk of death or cerebral palsy in their children at two years' corrected age., Design: Randomised, multicentre, placebo controlled trial., Inclusion Criteria: Women, giving informed consent, at risk of preterm birth between 30 to 34 weeks' gestation, where birth is planned or definitely expected within 24 hours, with a singleton or twin pregnancy and no contraindications to the use of magnesium sulphate.Trial entry & randomisation: Eligible women will be randomly allocated to receive either magnesium sulphate or placebo.Treatment groups: Women in the magnesium sulphate group will be administered 50 ml of a 100 ml infusion bag containing 8 g magnesium sulphate heptahydrate [16 mmol magnesium ions]. Women in the placebo group will be administered 50 ml of a 100 ml infusion bag containing isotonic sodium chloride solution (0.9%). Both treatments will be administered through a dedicated IV infusion line over 30 minutes.Primary study outcome: Death or cerebral palsy measured in children at two years' corrected age., Sample Size: 1676 children are required to detect a decrease in the combined outcome of death or cerebral palsy, from 9.6% with placebo to 5.4% with magnesium sulphate (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2)., Discussion: Given the magnitude of the protective effect in the systematic review, the ongoing uncertainty about benefits at later gestational ages, the serious health and cost consequences of cerebral palsy for the child, family and society, a trial of magnesium sulphate for women at risk of preterm birth between 30 to 34 weeks' gestation is both important and relevant for clinical practice globally., Trial Registration: Australian New Zealand Clinical Trials Registry - ACTRN12611000491965.

Background: The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes.This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities., Design: Multicentre, randomised controlled trial., Inclusion Criteria: Women between 240 and 346 weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L) and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L) with written, informed consent.Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L) will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the 'Routine Care Group' or the 'Intervention Group'.Study groups: Women in the 'Routine Care Group' will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the 'Intervention Group' will receive obstetric care, which will include dietary and lifestyle advice, monitoring of blood glucose and further medical treatment for hyperglycaemia as appropriate.Primary study outcome: Incidence of large for gestational age infants., Sample Size: A sample size of 682 women will be sufficient to show a 50% reduction in the risk of large for gestational age infants (alpha 0.05 two-tailed, 80% power, 4% loss to follow up) from 14% to 7% with dietary and lifestyle advice and treatment., Discussion: A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants., Trial Registration: Australian New Zealand Clinical Trials Registry - ACTRN12607000174482.

Background: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol., Methods/design: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia)., Discussion: Data analyses are expected to commence in 2011 with results publicly available in 2012.

Objective: To evaluate the effectiveness of surgical simulation compared with other methods of surgical training., Summary Background Data: Surgical simulation (with or without computers) is attractive because it avoids the use of patients for skills practice and provides relevant technical training for trainees before they operate on humans., Methods: Studies were identified through searches of MEDLINE, EMBASE, the Cochrane Library, and other databases until April 2005. Included studies must have been randomized controlled trials (RCTs) assessing any training technique using at least some elements of surgical simulation, which reported measures of surgical task performance., Results: Thirty RCTs with 760 participants were able to be included, although the quality of the RCTs was often poor. Computer simulation generally showed better results than no training at all (and than physical trainer/model training in one RCT), but was not convincingly superior to standard training (such as surgical drills) or video simulation (particularly when assessed by operative performance). Video simulation did not show consistently better results than groups with no training at all, and there were not enough data to determine if video simulation was better than standard training or the use of models. Model simulation may have been better than standard training, and cadaver training may have been better than model training., Conclusions: While there may be compelling reasons to reduce reliance on patients, cadavers, and animals for surgical training, none of the methods of simulated training has yet been shown to be better than other forms of surgical training.

The Australian Safety and Efficacy Register of New Interventiona lProcedures-Surgical (ASERNIP-S) exists primarily to assess new surgical technologies and techniques. It originally conducted systematic literature reviews, but now uses accelerated reviews, horizon scanning for emerging procedures, research and clinical audits,preparation of patient information, assistance with guideline development,and the production of research protocols of new surgical techniques. Future international cooperation and networking among health technology assessment groups will avoid duplication of effort and maximize outputs. Experience has shown that when surgeons lead in assessing new and emerging surgical techniques and technologies, the benefits of an evidence-based approach are realized, and the surgical community accepts the complementary role of evidence-based medicine in the provision of high-quality patient care.

The objective of this study was to evaluate the safety and efficacy of adult-to-adult living donor liver transplantation, specifically donor outcomes. A systematic review, with searches of the literature up to January 2004, was undertaken. Two hundred and fourteen studies provided information on donor outcomes. The majority of these were case series studies, although there were also studies comparing living donor liver transplantation with deceased donor liver transplantation. Both underreporting and duplicate reporting is likely to have occurred, and so caution is required in interpretation of these results. Overall reported donor mortality was 12 to 13 in about 6,000 procedures (0.2%) (117 studies). Mortality for right lobe donors to adult recipients is estimated to be 2 to 8 out of 3,800 (0.23 to 0.5%). The donor morbidity rate ranged from 0% to 100% with a median of 16% (131 studies). Biliary complications and infections were the most commonly reported donor morbidities. Nearly all donors had returned to normal function by 3 to 6 months (18 studies). In conclusion, there are small, but real, risks for living liver donors. Due to the short history of adult-to-adult living donor liver transplantation, the long-term risks for donors are unknown., (Copyright 2005 AASLD)

Purpose: The aim of this study was to systematically review the evidence relating to the safety and efficacy of transanal endoscopic microsurgery, a relatively new technique used to locally excise rectal tumors, compared with existing techniques such as anterior resections and abdominoperineal resections or local excisions., Methods: We conducted a systematic review of comparative studies and case series of transanal endoscopic microsurgery from 1980 to August 2002., Results: Three comparative studies (including one randomized, controlled trial) and 55 case series were included. The first area of study was the safety and efficacy of adenomas. In the randomized, controlled trial, no difference could be detected in the rate of early complications between transanal endoscopic microsurgery (10.3 percent) and direct local excision (17 percent) (relative risk, 0.61; 95 percent confidence interval, 0.29-1.29). Transanal endoscopic microsurgery resulted in less local recurrence (6/98; 6 percent) than direct local excision (20/90; 22 percent) (relative risk, 0.28; 95 percent confidence interval, 0.12-0.66). The 6 percent rate of local recurrence for transanal endoscopic microsurgery in this trial is consistent with the rates found in case series of transanal endoscopic microsurgery (median, 5 percent). The second area of study was the safety and efficacy of carcinomas. In the randomized, controlled trial, no difference could be detected in the rate of complications between transanal endoscopic microsurgery and direct local excision (relative risk for overall early complication rates, 0.56; 95 percent confidence interval, 0.22-1.42). No differences in survival or local recurrence rate between transanal endoscopic microsurgery and anterior resection could be detected in either the randomized, controlled trial (hazard ratio,1.02 for survival) or the nonrandomized, comparative study. There were 2 of 25 (8 percent) transanal endoscopic microsurgery recurrences in the randomized, controlled trial, but no figures were given for recurrence after anterior resection. In the case series, the median local recurrence rate for transanal endoscopic microsurgery was 8.4 percent, ranging from 0 percent to 50 percent. The third comparison was cost of the procedures. Transanal endoscopic microsurgery had both a lower recurrence rate and a lower cost than local excision or anterior resection for adenomas. Although the effectiveness of transanal endoscopic microsurgery could not be established for carcinomas, costs were lower than those for either anterior resection or abdominoperineal resection., Conclusions: The evidence regarding transanal endoscopic microsurgery is very limited, being largely based on a single relatively small randomized, controlled trial. However, transanal endoscopic microsurgery does appear to result in fewer recurrences than those with direct local excision in adenomas and thus may be a useful procedure for several small niches of patient types--e.g., for large benign lesions of the middle to upper third of the rectum, for T1 low-risk rectal cancers, and for palliative, not curative, use in more advanced tumors.

Objective: To pilot a clinical information service for general practitioners., Methods: A representative sample of 31 GPs was invited to submit clinical questions to a local academic department of general practice. Their views on the service and the usefulness of the information were obtained by telephone interview., Results: Over one month, nine GPs (29% of the sample, 45% of those stating an interest), submitted 20 enquiries comprising 45 discrete clinical questions. The median time to search for evidence, appraise it and write answers to each enquiry was 2.5 hours (range, 1.0-7.4 hours). The median interval between receipt of questions and dispatch of answers was 3 days (range, 1-12 days)., Conclusions: The GPs found the answers useful in clinical decision making; in four out of 20 cases patient management was altered.