Caroline A Crowther

University of Adelaide, Tarndarnya, South Australia, Australia

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Publications (306)2004.43 Total impact

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    ABSTRACT: To report the influence of maternal overweight and obesity on fetal growth and adiposity and effects of an antenatal dietary and lifestyle intervention among these women on measures of fetal growth and adiposity as secondary outcomes of the LIMIT Trial. Randomised controlled trial. Public maternity hospitals in metropolitan Adelaide, South Australia. Pregnant women with a body mass index ≥ 25 kg/m2, and singleton gestation between 10+0 and 20+0 weeks. Women were randomised to Lifestyle Advice or continued Standard Care and offered two research ultrasound scans at 28 and 36 weeks of gestation. Ultrasound measures of fetal growth and adiposity. For each fetal body composition parameter, mean Z-scores were substantially higher when compared with population standards. Fetuses of women receiving Lifestyle Advice demonstrated significantly greater mean mid-thigh fat mass, when compared with fetuses of women receiving Standard Care (adjusted difference in means 0.17; 95% CI 0.02–0.32; P = 0.0245). While subscapular fat mass increased between 28 and 36 weeks of gestation in fetuses in both treatment groups, the rate of adipose tissue deposition slowed among fetuses of women receiving Lifestyle Advice, when compared with fetuses of women receiving Standard Care (P = 0.0160). No other significant differences were observed. These findings provide the first evidence of changes to fetal growth following an antenatal dietary and lifestyle intervention among women who are overweight or obese. Lifestyle advice for overweight and obese pregnant women modifies fetal body composition.
    No preview · Article · Feb 2016 · BJOG An International Journal of Obstetrics & Gynaecology
  • Emily Bain · Philippa Middleton · Caroline A Crowther
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    ABSTRACT: Outcomes in gestational diabetes Cochrane protocols and reviews before and after development of 'standard outcomes' by WOMBAT (WOMen and Babies health and well-being: Action through Trials) were surveyed. An increase in 'common' outcomes (those prespecified by ≥50% of the protocols and reviews) over time was observed (2001-2009: 27 vs 2010-2014: 46). There were discrepancies in outcomes prespecified in reviews and reported by randomised trials. Efforts are needed to develop a core outcome set, to reduce research waste and improve health outcomes.
    No preview · Article · Jan 2016 · Australian and New Zealand Journal of Obstetrics and Gynaecology
  • Tineke J Crawford · Caroline A Crowther · Jane Alsweiler · Julie Brown
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    ABSTRACT: Background: Gestational diabetes, glucose intolerance with onset or first recognition during pregnancy, is a rising problem worldwide. Both non-pharmacological and pharmacological approaches to the prevention of gestational diabetes have been, and continue to be explored. Myo-inositol, an isomer of inositol, is a naturally occurring sugar commonly found in cereals, corn, legumes and meat. It is one of the intracellular mediators of the insulin signal and correlated with insulin sensitivity in type 2 diabetes. The potential beneficial effect on improving insulin sensitivity suggests that myo-inositol may be useful for women in preventing gestational diabetes. Objectives: To assess if antenatal dietary supplementation with myo-inositol is safe and effective, for the mother and fetus, in preventing gestational diabetes. Search methods: We searched the Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, WHO ICTRP (2 November 2015) and reference lists of retrieved studies. Selection criteria: We sought published and unpublished randomised controlled trials, including conference abstracts, assessing the effects of myo-inositol for the prevention of gestational diabetes mellitus (GDM). Quasi-randomised and cross-over trials were not eligible for inclusion, but cluster designs were eligible. Participants in the trials were pregnant women. Women with pre-existing type 1 or type 2 diabetes were excluded. Trials that compared the administration of any dose of myo-inositol, alone or in a combination preparation were eligible for inclusion. Trials that used no treatment, placebo or another intervention as the comparator were eligible for inclusion. Data collection and analysis: Two review authors independently assessed trials for inclusion, risk of bias and extracted the data. Data were checked for accuracy. Main results: We included four randomised controlled trials (all conducted in Italy) reporting on 567 women who were less than 11 weeks' to 24 weeks' pregnant at the start of the trials. The trials had small sample sizes and one trial only reported an interim analysis. Two trials were open-label. The overall risk of bias was unclear.For the mother, supplementation with myo-inositol was associated with a reduction in the incidence of gestational diabetes compared with control (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.29 to 0.64; three trials; n = 502 women). Using GRADE methods this evidence was assessed as low with downgrading due to unclear risk of bias for allocation concealment in two of the included trials and lack of generalisability of findings. For women who received myo-inositol supplementation, the incidence of GDM ranged from 8% to 18%; for women in the control group, the incidence of GDM was 28%, using International Association of Diabetes and Pregnancy Study Groups Consensus Panel 2010 criteria to diagnose GDM.Two trials reported on hypertensive disorders of pregnancy, a primary maternal outcome of this review. There was no clear difference in risk of hypertensive disorders of pregnancy between the myo-inositol and control groups (average RR 0.43, 95% CI 0.02 to 8.41; two trials; n = 398 women; Tau(2) = 3.23; I(2) = 69%). Using GRADE methods, this evidence was assessed as very low, with downgrading due to wide confidence intervals with very low event rates, a small sample size, and lack of blinding and unclear allocation concealment methods, and a lack of generalisability. For women who received myo-inositol the risk of hypertensive disorders of pregnancy ranged from 0% to 33%; for women in the control group the risk was 4%.For the infant, none of the included trials reported on the primary neonatal outcomes of this systematic review (large-for-gestational age, perinatal mortality, mortality or morbidity composite).In terms of this review's secondary outcomes, there was no clear difference in the risk of caesarean section between the myo-inositol and control groups (RR 0.95, 95% CI 0.76 to 1.19; two trials; n = 398 women). Using GRADE methods, this evidence was assessed as low, with downgrading due to unclear risk of bias in one trial and lack of generalisability. For women who received myo-inositol supplementation, the risk of having a caesarean section ranged from 34% to 54%; for women in the control group the was 45%. There were no maternal adverse effects of therapy in the two trials that reported on this outcome (the other two trials did not report this outcome).Two trials found no clear difference in the risk of macrosomia between infants whose mothers received myo-inositol supplementation compared with controls (average RR 0.35, 95% CI 0.02 to 6.37; two trials; n = 398 infants;Tau(2) = 3.33; I(2) = 73%). Similarly, there was no clear difference between groups in terms of neonatal hypoglycaemia (RR 0.36, 95% CI 0.01 to 8.66) or shoulder dystocia (average RR 2.33, 95% CI 0.12 to 44.30, Tau(2) = 3.24; I(2) = 72%).There was a lack of data available for a large number of maternal and neonatal secondary outcomes, and no data for any of the long-term childhood or adulthood outcomes, or for health service cost outcomes. Authors' conclusions: Evidence from four trials of antenatal dietary supplementation with myo-inositol during pregnancy shows a potential benefit for reducing the incidence of gestational diabetes. No data were reported for any of this review's primary neonatal outcomes. There were very little outcome data for the majority of this review's secondary outcomes. There is no clear evidence of a difference for macrosomia when compared with control.The current evidence is based on small trials that are not powered to detect differences in outcomes including perinatal mortality and serious infant morbidity. All of the included studies were conducted in Italy which raises concerns about the lack of generalisability of the evidence to other settings. There is evidence of inconsistency and indirectness and as a result, many of the judgements on the quality of the evidence were downgraded to low or very low quality (GRADEpro Guideline Development Tool).Further trials for this promising antenatal intervention for preventing gestational diabetes are encouraged and should include pregnant women of different ethnicities and varying risk factors and use of myo-inositol (different doses, frequency and timing of administration) in comparison with placebo, diet and exercise or pharmacological interventions. Outcomes should include potential harms including adverse effects.
    No preview · Article · Dec 2015 · Cochrane database of systematic reviews (Online)
  • Helen C McNamara · Caroline A Crowther · Julie Brown
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    ABSTRACT: Background: Magnesium sulphate has been used to inhibit preterm labour to prevent preterm birth. There is no consensus as to the safety profile of different treatment regimens with respect to dose, duration, route and timing of administration. Objectives: To assess the efficacy and safety of alternative magnesium sulphate regimens when used as single agent tocolytic therapy during pregnancy. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2015) and reference lists of retrieved studies. Selection criteria: Randomised trials comparing different magnesium sulphate treatment regimens when used as single agent tocolytic therapy during pregnancy in women in preterm labour. Quasi-randomised trials were eligible for inclusion but none were identified. Cross-over and cluster trials were not eligible for inclusion. Health outcomes were considered at the level of the mother, the infant/child and the health service. Intervention: intravenous or oral magnesium sulphate given alone for tocolysis.Comparison: alternative dosing regimens of magnesium sulphate given alone for tocolysis. Data collection and analysis: Two review authors independently assessed trial eligibility and quality and extracted data. Main results: Three trials including 360 women and their infants were identified as eligible for inclusion in this review. Two trials were rated as low risk of bias for random sequence generation and concealment of allocation. A third trial was assessed as unclear risk of bias for these domains but did not report data for any of the outcomes examined in this review. No trials were rated to be of high quality overall.Intravenous magnesium sulphate was administered according to low-dose regimens (4 g loading dose followed by 2 g/hour continuous infusion and/or increased by 1 g/hour hourly until successful tocolysis or failure of treatment), or high-dose regimens (4 g loading dose followed by 5 g/hour continuous infusion and increased by 1 g/hour hourly until successful tocolysis or failure of treatment, or 6 g loading dose followed by 2 g/hour continuous infusion and increased by 1 g/hour hourly until successful tocolysis or failure of treatment).There were no differences seen between high-dose magnesium sulphate regimens compared with low-dose magnesium sulphate regimens for the primary outcome of fetal, neonatal and infant death (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.12 to 1.56; one trial, 100 infants). Using the GRADE approach, the evidence for fetal, neonatal and infant death was considered to be VERY LOW quality. No data were reported for any of the other primary maternal and infant health outcomes (birth less than 48 hours after trial entry; composite serious infant outcome; composite serious maternal outcome).There were no clear differences seen between high-dose magnesium sulphate regimens compared with low-dose magnesium sulphate regimens for the secondary infant health outcomes of fetal death; neonatal death; and rate of hypocalcaemia, osteopenia or fracture; and secondary maternal health outcomes of rate of caesarean birth; pulmonary oedema; and maternal self-reported adverse effects. Pulmonary oedema was reported in two women given high-dose magnesium sulphate, but not in any of the women given low-dose magnesium sulphate.In a single trial of high and low doses of magnesium sulphate for tocolysis including 100 infants, the risk of respiratory distress syndrome was lower with use of a high-dose regimen compared with a low-dose regimen (RR 0.31, 95% CI 0.11 to 0.88; one trial, 100 infants). Using the GRADE approach, the evidence for respiratory distress syndrome was judged to be LOW quality. No difference was seen in the rate of admission to the neonatal intensive care unit. However, for those babies admitted, a high-dose regimen was associated with a reduction in the length of stay in the neonatal intensive care unit compared with a low-dose regimen (mean difference -3.10 days, 95% confidence interval -5.48 to -0.72).We found no data for the majority of our secondary outcomes. Authors' conclusions: There are limited data available (three studies, with data from only two studies) comparing different dosing regimens of magnesium sulphate given as single agent tocolytic therapy for the prevention of preterm birth. There is no evidence examining duration of therapy, timing of therapy and the role for repeat dosing.Downgrading decisions for our primary outcome of fetal, neonatal and infant death were based on wide confidence intervals (crossing the line of no effect), lack of blinding and a limited number of studies. No data were available for any of our other important outcomes: birth less than 48 hours after trial entry; composite serious infant outcome; composite serious maternal outcome. The data are limited by volume and the outcomes reported. Only eight of our 45 pre-specified primary and secondary maternal and infant health outcomes were reported on in the included studies. No long-term outcomes were reported. Downgrading decisions for the evidence on the risk of respiratory distress were based on wide confidence intervals (crossing the line of no effect) and lack of blinding.There is some evidence from a single study suggesting a reduction in the length of stay in the neonatal intensive care unit and a reduced risk of respiratory distress syndrome where a high-dose regimen of magnesium sulphate has been used compared with a low-dose regimen. However, given that evidence has been drawn from a single study (with a small sample size), these data should be interpreted with caution.Magnesium sulphate has been shown to be of benefit in a wide range of obstetric settings, although it has not been recommended for tocolysis. In clinical settings where health benefits are established, further trials are needed to address the lack of evidence regarding the optimal dose (loading dose and maintenance dose), duration of therapy, timing of therapy and role for repeat dosing in terms of efficacy and safety for mothers and their children. Ongoing examination of different regimens with respect to important health outcomes is required.
    No preview · Article · Dec 2015 · Cochrane database of systematic reviews (Online)
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    ABSTRACT: Strong evidence supports administration of magnesium sulphate prior to birth at less than 30 weeks' gestation to prevent very preterm babies dying or developing cerebral palsy. This study was undertaken as part of The WISH (Working to Improve Survival and Health for babies born very preterm) Project, to assess health professionals' self-reported use of antenatal magnesium sulphate, and barriers and enablers to implementation of 2010 Australian and New Zealand clinical practice guidelines. Semi-structured, one-to-one interviews were conducted with obstetric and neonatal consultants and trainees, and midwives in 2011 (n = 24) and 2012-2013 (n = 21) at the Women's and Children's Hospital, South Australia. Transcribed interview data were coded using the Theoretical Domains Framework (describing 14 domains related to behaviour change) for analysis of barriers and enablers. In 2012-13, health professionals more often reported 'routinely' or 'sometimes' administering or advising their colleagues to administer magnesium sulphate for fetal neuroprotection (86 % in 2012-13 vs. 46 % in 2011). 'Knowledge and skills', 'memory, attention and decision processes', 'environmental context and resources', 'beliefs about consequences' and 'social influences' were key domains identified in the barrier and enabler analysis. Perceived barriers were the complex administration processes, time pressures, and the unpredictability of preterm birth. Enablers included education for staff and women at risk of very preterm birth, reminders and 'prompts', simplified processes for administration, and influential colleagues. This study has provided valuable data on barriers and enablers to implementing magnesium sulphate for fetal neuroprotection, with implications for designing and modifying future behaviour change strategies, to ensure optimal uptake of this neuroprotective therapy for very preterm infants.
    Full-text · Article · Dec 2015 · BMC Pregnancy and Childbirth
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    ABSTRACT: Preterm birth and very small size at birth have long-term effects on neurodevelopment and growth. A relatively small percentage of extremely low birthweight babies suffer from severe neurological disability; however, up to 50 % experience some neurodevelopmental or learning disability in childhood. Current international consensus is that increased protein intake in the neonatal period improves both neurodevelopment and growth, but the quantum of protein required is not known. This trial aims to assess whether providing an extra 1 to 2 g.kg(-1).d(-1) protein in the first 5 days after birth will improve neurodevelopmental outcomes and growth in extremely low birthweight babies. The ProVIDe study is a multicentre, two-arm, double-blind, parallel, randomised, controlled trial. In addition to standard intravenous nutrition, 430 babies with a birthweight of less than 1000 g who have an umbilical arterial line in situ will be randomised in 1:1 ratio to receive either an amino acid solution (TrophAmine®) or placebo (saline) administered through the umbilical arterial catheter for the first 5 days. Exclusion criteria are admission to neonatal intensive care more than 24 h after birth; multiple births of more than 2 babies; known chromosomal or genetic abnormality, or congenital disorder affecting growth; inborn error of metabolism, and in danger of imminent death. Survival free from neurodevelopmental disability at 2 years' corrected age, where neurodevelopmental disability is defined as cerebral palsy, blindness, deafness, developmental delay (standardised score more than 1 SD below the mean on the cognitive, language or motor subscales of the Bayley Scales of Infant Development Edition 3), or Gross Motor Function Classification System score ≥1. Growth, from birth to 36 weeks' corrected gestational age, at neonatal intensive care discharge and at 2 years' corrected age; body composition at 36 to 42 weeks' corrected postmenstrual age and at 2 years' corrected age; neonatal morbidity, including length of stay; nutritional intake. This trial will provide the first direct evidence of the effects of giving preterm babies a higher intake of intravenous protein in the first week after birth on neurodevelopmental outcomes at 2 years corrected age. Australian New Zealand Clinical Trials Registry: ACTRN12612001084875 .
    Full-text · Article · Dec 2015 · BMC Pediatrics
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    ABSTRACT: Introduction: Our aim was to evaluate the effect of dietary and lifestyle advice to women who were overweight or obese during pregnancy on maternal quality of life, anxiety and risk of depression, and satisfaction with care. Material and methods: We conducted a randomized trial, involving pregnant women with body mass index >25kg/m(2) , recruited from maternity units in South Australia. Women were randomized to Lifestyle Advice or Standard Care, and completed questionnaires assessing risk of depression (Edinburgh Postnatal Depression Scale), anxiety (Speilberger State-Trait Anxiety Inventory), and quality of life (SF-36) at trial-entry, 28 and 36 weeks gestation, and four months postpartum. Secondary trial outcomes assessed for this analysis were risk of depression, anxiety, maternal quality of life, and satisfaction with care. Results: One or more questionnaires were completed by 976 of 1,108 (90.8%) women receiving Lifestyle Advice and 957 of 1,104 (89.7%) women receiving Standard Care. The risk of depression (adjusted risk ratio 1.01; 95% CI 0.82-1.24; p=0.95), anxiety (adjusted risk ratio 1.09; 95% CI 0.93-1.27; p=0.31), and health related quality of life were similar between the two groups. Women receiving Lifestyle Advice reported improved healthy food choice (Lifestyle Advice 404 (68.9%) vs Standard Care 323 (51.8%); p<0.0001), and exercise (Lifestyle Advice 444 (75.8%) vs Standard Care 367 (58.8%); p<0.0001) knowledge, and reassurance about their (Lifestyle Advice 499 (85.3%) vs Standard Care 485 (77.9%); p=0.0112), and their baby's health (Lifestyle Advice 527 (90.2%) vs Standard Care 545 (87.6%); p=0.0143). Conclusion: Lifestyle Advice in pregnancy improved knowledge and provided reassurance without negatively impacting well-being. This article is protected by copyright. All rights reserved.
    No preview · Article · Nov 2015 · Acta Obstetricia Et Gynecologica Scandinavica
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    ABSTRACT: Background: Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. We aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity. Methods: The PPROMT trial was a multicentre randomised controlled trial done at 65 centres across 11 countries. Women aged over 16 years with singleton pregnancies and ruptured membranes before the onset of labour between 34 weeks and 36 weeks and 6 days weeks who had no signs of infection were included. Women were randomly assigned (1:1) by a computer-generated randomisation schedule with variable block sizes, stratified by centre, to immediate delivery or expectant management. The primary outcome was the incidence of neonatal sepsis. Secondary infant outcomes included a composite neonatal morbidity and mortality indicator (ie, sepsis, mechanical ventilation ≥24 h, stillbirth, or neonatal death); respiratory distress syndrome; any mechanical ventilation; and duration of stay in a neonatal intensive or special care unit. Secondary maternal outcomes included antepartum or intrapartum haemorrhage, intrapartum fever, postpartum treatment with antibiotics, and mode of delivery. Women and caregivers could not be masked, but those adjudicating on the primary outcome were masked to group allocation. Analyses were by intention to treat. This trial is registered with the International Clinical Trials Registry, number ISRCTN44485060. Findings: Between May 28, 2004, and June 30, 2013, 1839 women were recruited and randomly assigned: 924 to the immediate birth group and 915 to the expectant management group. One woman in the immediate birth group and three in the expectant group were excluded from the primary analyses. Neonatal sepsis occurred in 23 (2%) of 923 neonates whose mothers were assigned to immediate birth and 29 (3%) of 912 neonates of mothers assigned to expectant management (relative risk [RR] 0·8, 95% CI 0·5-1·3; p=0·37). The composite secondary outcome of neonatal morbidity and mortality occurred in 73 (8%) of 923 neonates of mothers assigned to immediate delivery and 61 (7%) of 911 neonates of mothers assigned to expectant management (RR 1·2, 95% CI 0·9-1·6; p=0·32). However, neonates born to mothers in the immediate delivery group had increased rates of respiratory distress (76 [8%] of 919 vs 47 [5%] of 910, RR 1·6, 95% CI 1·1-2·30; p=0·008) and any mechanical ventilation (114 [12%] of 923 vs 83 [9%] of 912, RR 1·4, 95% CI 1·0-1·8; p=0·02) and spent more time in intensive care (median 4·0 days [IQR 0·0-10·0] vs 2·0 days [0·0-7·0]; p<0·0001) compared with neonates born to mothers in the expectant management group. Compared with women assigned to the immediate delivery group, those assigned to the expectant management group had higher risks of antepartum or intrapartum haemorrhage (RR 0·6, 95% CI 0·4-0·9), intrapartum fever (0·4, 0·2-0·9), and use of postpartum antibiotics (0·8, 0·7-1·0), and longer hospital stay (p<0·0001), but a lower risk of caesarean delivery (RR 1·4, 95% CI 1·2-1·7). Interpretation: In the absence of overt signs of infection or fetal compromise, a policy of expectant management with appropriate surveillance of maternal and fetal wellbeing should be followed in pregnant women who present with ruptured membranes close to term. Funding: Australian National Health and Medical Research Council, the Women's and Children's Hospital Foundation, and The University of Sydney.
    Full-text · Article · Nov 2015 · The Lancet
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    Alice Rumbold · Erika Ota · Chie Nagata · Sadequa Shahrook · Caroline A Crowther
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    ABSTRACT: Background: Vitamin C supplementation may help reduce the risk of pregnancy complications such as pre-eclampsia, intrauterine growth restriction and maternal anaemia. There is a need to evaluate the efficacy and safety of vitamin C supplementation in pregnancy. Objectives: To evaluate the effects of vitamin C supplementation, alone or in combination with other separate supplements on pregnancy outcomes, adverse events, side effects and use of health resources. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies. Selection criteria: All randomised or quasi-randomised controlled trials evaluating vitamin C supplementation in pregnant women. Interventions using a multivitamin supplement containing vitamin C or where the primary supplement was iron were excluded. Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Main results: Twenty-nine trials involving 24,300 women are included in this review. Overall, 11 trials were judged to be of low risk of bias, eight were high risk of bias and for 10 trials it was unclear. No clear differences were seen between women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control for the risk of stillbirth (risk ratio (RR) 1.15, 95% confidence intervals (CI) 0.89 to 1.49; 20,038 participants; 11 studies; I² = 0%; moderate quality evidence), neonatal death (RR 0.79, 95% CI 0.58 to 1.08; 19,575 participants; 11 studies; I² = 0%), perinatal death (average RR 1.07, 95% CI 0.77 to 1.49; 17,105 participants; seven studies; I² = 35%), birthweight (mean difference (MD) 26.88 g, 95% CI -18.81 to 72.58; 17,326 participants; 13 studies; I² = 69%), intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06; 20,361 participants; 12 studies; I² = 15%; high quality evidence), preterm birth (average RR 0.99, 95% CI 0.90 to 1.10; 22,250 participants; 16 studies; I² = 49%; high quality evidence), preterm PROM (prelabour rupture of membranes) (average RR 0.98, 95% CI 0.70 to 1.36; 16,825 participants; 10 studies; I² = 70%; low quality evidence), term PROM (average RR 1.26, 95% CI 0.62 to 2.56; 2674 participants; three studies; I² = 87%), and clinical pre-eclampsia (average RR 0.92, 95% CI 0.80 to 1.05; 21,956 participants; 16 studies; I² = 41%; high quality evidence).Women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control were at decreased risk of having a placental abruption (RR 0.64, 95% CI 0.44 to 0.92; 15,755 participants; eight studies; I² = 0%; high quality evidence) and had a small increase in gestational age at birth (MD 0.31, 95% CI 0.01 to 0.61; 14,062 participants; nine studies; I² = 65%), however they were also more likely to self-report abdominal pain (RR 1.66, 95% CI 1.16 to 2.37; 1877 participants; one study). In the subgroup analyses based on the type of supplement, vitamin C supplementation alone was associated with a reduced risk of preterm PROM (average RR 0.66, 95% CI 0.48 to 0.91; 1282 participants; five studies; I² = 0%) and term PROM (average RR 0.55, 95% CI 0.32 to 0.94; 170 participants; one study). Conversely, the risk of term PROM was increased when supplementation included vitamin C and vitamin E (average RR 1.73, 95% CI 1.34 to 2.23; 3060 participants; two studies; I² = 0%). There were no differences in the effects of vitamin C on other outcomes in the subgroup analyses examining the type of supplement. There were no differing patterns in other subgroups of women based on underlying risk of pregnancy complications, timing of commencement of supplementation or dietary intake of vitamin C prior to trial entry. The GRADE quality of the evidence was high for intrauterine growth restriction, preterm birth, and placental abruption, moderate for stillbirth and clinical pre-eclampsia, low for preterm PROM. Authors' conclusions: The data do not support routine vitamin C supplementation alone or in combination with other supplements for the prevention of fetal or neonatal death, poor fetal growth, preterm birth or pre-eclampsia. Further research is required to elucidate the possible role of vitamin C in the prevention of placental abruption and prelabour rupture of membranes. There was no convincing evidence that vitamin C supplementation alone or in combination with other supplements results in other important benefits or harms.
    Full-text · Article · Sep 2015 · Cochrane database of systematic reviews (Online)
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    ABSTRACT: Aim: To identify factors influencing postpartum healthcare seeking, from the perspective of women who have experienced gestational diabetes mellitus (GDM). Methods: Systematic review that searched PubMed, Web of Science, EMBASE and CINAHL on 27th February 2013. Qualitative studies and surveys, with women as participants, which reported pre-specified outcomes, including barriers and facilitators to healthcare seeking for GDM after birth, were included. Two authors independently extracted data and assessed quality. Results were thematically synthesised. Results: Forty-two studies were included, with data from 7949 women in several countries. The diagnosis of GDM was sometimes a concerning or upsetting experience. A need for more specific information about GDM to be available around the time of diagnosis was identified. Women had varied experiences of antenatal GDM care and management, ranging from very positive to difficult and confusing. Non-judgemental and positively focussed care was preferred. While women were often knowledgeable about type 2 diabetes risk and prevention, they faced multiple barriers to undertaking preventive behaviours. A need for lifestyle change support and more pro-active postpartum care was identified. Conclusions: Provision of improved GDM education, as well as positive and pro-active care from diagnosis until postpartum follow-up may increase healthcare seeking by women with recent GDM.
    No preview · Article · Sep 2015 · Diabetes Research and Clinical Practice
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    ABSTRACT: Background: Neonatal hypoglycaemia is common, affecting up to 15 % of newborn babies and 50 % of those with risk factors (preterm, infant of a diabetic, high or low birthweight). Hypoglycaemia can cause brain damage and death, and babies born at risk have an increased risk of developmental delay in later life. Treatment of hypoglycaemia usually involves additional feeding, often with infant formula, and admission to Neonatal Intensive Care for intravenous dextrose. This can be costly and inhibit the establishment of breast feeding. Prevention of neonatal hypoglycaemia would be desirable, but there are currently no strategies, beyond early feeding, for prevention of neonatal hypoglycaemia. Buccal dextrose gel is safe and effective in treatment of hypoglycaemia. The aim of this trial is to determine whether 40 % dextrose gel given to babies at risk prevents neonatal hypoglycaemia and hence reduces admission to Neonatal Intensive Care. Methods/design: Design: Randomised, multicentre, placebo controlled trial. Inclusion criteria: Babies at risk of hypoglycaemia (preterm, infant of a diabetic, small or large), less than 1 h old, with no apparent indication for Neonatal Intensive Care Unit admission and mother intends to breastfeed. Trial entry & randomisation: Eligible babies of consenting parents will be allocated by online randomisation to the dextrose gel group or placebo group, using a study number and corresponding trial intervention pack. Study groups: Babies will receive a single dose of 0.5 ml/kg study gel at 1 h after birth; either 40 % dextrose gel (200 mg/kg) or 2 % hydroxymethylcellulose placebo. Gel will be massaged into the buccal mucosal and followed by a breast feed. Primary study outcome: Admission to Neonatal Intensive Care. Sample size: 2,129 babies are required to detect a decrease in admission to Neonatal Intensive Care from 10-6 % (two-sided alpha 0.05, 90 % power, 5 % drop-out rate). Discussion: This study will investigate whether admission to Neonatal Intensive Care can be prevented by prophylactic oral dextrose gel; a simple, cheap and painless intervention that requires no special expertise or equipment and hence is applicable in almost any birth setting. Trial registration: Australian New Zealand Clinical Trials Registry - ACTRN 12614001263684 .
    Full-text · Article · Sep 2015 · BMC Pediatrics
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    Alice Rumbold · Erika Ota · Hiroyuki Hori · Celine Miyazaki · Caroline A Crowther
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    ABSTRACT: Background: Vitamin E supplementation may help reduce the risk of pregnancy complications involving oxidative stress, such as pre-eclampsia. There is a need to evaluate the efficacy and safety of vitamin E supplementation in pregnancy. Objectives: To assess the effects of vitamin E supplementation, alone or in combination with other separate supplements, on pregnancy outcomes, adverse events, side effects and use of health services. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies. Selection criteria: All randomised or quasi-randomised controlled trials evaluating vitamin E supplementation in pregnant women. We excluded interventions using a multivitamin supplement that contained vitamin E. Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Main results: Twenty-one trials, involving 22,129 women were eligible for this review. Four trials did not contribute data. All of the remaining 17 trials assessed vitamin E in combination with vitamin C and/or other agents. Overall the risk of bias ranged from low to unclear to high; 10 trials were judged to be at low risk of bias, six trials to be at unclear risk of bias and five trials to be at high risk of bias. No clear difference was found between women supplemented with vitamin E in combination with other supplements during pregnancy compared with placebo for the risk of stillbirth (risk ratio (RR) 1.17, 95% confidence interval (CI) 0.88 to 1.56, nine studies, 19,023 participants, I² = 0%; moderate quality evidence), neonatal death (RR 0.81, 95% CI 0.58 to 1.13, nine trials, 18,617 participants, I² = 0%), pre-eclampsia (average RR 0.91, 95% CI 0.79 to 1.06; 14 trials, 20,878 participants; I² = 48%; moderate quality evidence), preterm birth (average RR 0.98, 95% CI 0.88 to 1.09, 11 trials, 20,565 participants, I² = 52%; high quality evidence) or intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06, 11 trials, 20,202 participants, I² = 17%; high quality evidence). Women supplemented with vitamin E in combination with other supplements compared with placebo were at decreased risk of having a placental abruption (RR 0.64, 95% CI 0.44 to 0.93, seven trials, 14,922 participants, I² = 0%; high quality evidence). Conversely, supplementation with vitamin E was associated with an increased risk of self-reported abdominal pain (RR 1.66, 95% CI 1.16 to 2.37, one trial, 1877 participants) and term prelabour rupture of membranes (PROM) (average RR 1.77, 95% CI 1.37 to 2.28, two trials, 2504 participants, I² = 0%); however, there was no corresponding increased risk for preterm PROM (average RR 1.27, 95% CI 0.93 to 1.75, five trials, 1999 participants, I² = 66%; low quality evidence). There were no clear differences between the vitamin E and placebo or control groups for any other maternal or infant outcomes. There were no clear differing patterns in subgroups of women based on the timing of commencement of supplementation or baseline risk of adverse pregnancy outcomes. The GRADE quality of the evidence was high for preterm birth, intrauterine growth restriction and placental abruption, moderate for stillbirth and clinical pre-eclampsia, and low for preterm PROM. Authors' conclusions: The data do not support routine vitamin E supplementation in combination with other supplements for the prevention of stillbirth, neonatal death, preterm birth, pre-eclampsia, preterm or term PROM or poor fetal growth. Further research is required to elucidate the possible role of vitamin E in the prevention of placental abruption. There was no convincing evidence that vitamin E supplementation in combination with other supplements results in other important benefits or harms.
    Full-text · Article · Sep 2015 · Cochrane database of systematic reviews (Online)
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    ABSTRACT: Importance: Antenatal magnesium sulfate given to pregnant women at imminent risk of very preterm delivery reduces the risk of cerebral palsy in early childhood, although its effects into school age have not been reported from randomized trials. Objective: To determine the association between exposure to antenatal magnesium sulfate and neurological, cognitive, academic, and behavioral outcomes at school age. Design, setting, and participants: The ACTOMgSO4 was a randomized clinical trial conducted in 16 centers in Australia and New Zealand, comparing magnesium sulfate with placebo given to pregnant women (n = 535 magnesium; n = 527 placebo) for whom imminent birth was planned or expected before 30 weeks' gestation. Children who survived from the 14 centers who participated in the school-age follow-up (n = 443 magnesium; n = 424 placebo) were invited for an assessment at 6 to 11 years of age between 2005 and 2011. Main outcomes and measures: Mortality, cerebral palsy, motor function, IQ, basic academic skills, attention and executive function, behavior, growth, and functional outcomes. Main analyses were imputed for missing data. Results: Of the 1255 fetuses known to be alive at randomization, the mortality rate to school age was 14% (88/629) in the magnesium sulfate group and 18% (110/626) in the placebo group (risk ratio [RR], 0.80; 95% CI, 0.62-1.03, P = .08). Of 867 survivors available for follow-up, outcomes at school age (corrected age 6-11 years) were determined for 669 (77%). Comparing the magnesium sulfate and placebo groups revealed no statistically significant difference in proportions with cerebral palsy (23/295 [8%] and 21/314 [7%], respectively; odds ratio [OR], 1.26; 95% CI, 0.84-1.91; P = .27) or abnormal motor function (80/297 [27%] and 80/300 [27%], respectively; OR, 1.16; 95% CI, 0.88-1.52; P = .28). There was also little difference between groups on any of the cognitive, behavioral, growth, or functional outcomes. Conclusions and relevance: Magnesium sulfate given to pregnant women at imminent risk of birth before 30 weeks' gestation was not associated with neurological, cognitive, behavioral, growth, or functional outcomes in their children at school age, although a mortality advantage cannot be excluded. The lack of long-term benefit requires confirmation in additional studies. Trial registration: anzctr.org.au Identifier: ACTRN12606000252516.
    No preview · Article · Sep 2015 · Obstetric Anesthesia Digest
  • Emer Van Ryswyk · Philippa Middleton · William Hague · Caroline Crowther
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    ABSTRACT: 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. 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. 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%). 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.
    No preview · Article · Jul 2015 · Primary Care Diabetes
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    ABSTRACT: Australian and New Zealand clinical practice guidelines, endorsed by the NHMRC in 2010, recommend administration of antenatal magnesium sulphate to women at risk of imminent preterm birth at less than 30 weeks' gestation to reduce the risk of their very preterm babies dying or having cerebral palsy. The purpose of the ongoing Working to Improve Survival and Health for babies born very preterm (WISH) implementation project is to monitor and improve the uptake of this neuroprotective therapy across Australia and New Zealand. To quantify and explore reasons for nonreceipt of antenatal magnesium sulphate at the Women's and Children's Hospital, in Adelaide, South Australia. Data from the case records of women who gave birth between 23(+0) and 29(+6) weeks' gestation from 2010 to mid-2013 were reviewed to determine the proportion of eligible mothers not receiving antenatal magnesium sulphate and to explore reason(s) for nonreceipt over this time period. There was a reduction in the proportion of eligible mothers not receiving antenatal magnesium sulphate from 2010 (69.7%) to 2011 (26.9%), which was maintained in 2012 and 2013 (22.5%). In 2012-2013, nonreceipt was predominantly associated with immediately imminent (advanced labour, rapid progression of labour) or indicated emergent birth (actual or suspected maternal or fetal compromise). Use of antenatal magnesium sulphate at the Women's and Children's Hospital is now predominantly in-line with the binational guideline recommendations. Ongoing education and enhanced familiarity with procedures may facilitate timely administration in the context of some precipitous or immediately imminent births. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
    No preview · Article · Jun 2015 · Australian and New Zealand Journal of Obstetrics and Gynaecology
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    ABSTRACT: 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.
    Full-text · Article · May 2015 · EBioMedicine
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    Full-text · Article · Apr 2015 · Cochrane database of systematic reviews (Online)
  • Emer Van Ryswyk · Philippa Middleton · William Hague · Caroline Crowther
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    ABSTRACT: AimsThis 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.ResultsWomen 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), 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.This article is protected by copyright. All rights reserved.
    No preview · Article · Mar 2015 · Diabetic Medicine
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    Full-text · Dataset · Mar 2015
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    ABSTRACT: Background Overweight and obesity during pregnancy is common, although robust evidence about the economic implications of providing an antenatal dietary and lifestyle intervention for women who are overweight or obese is lacking. We conducted a health economic evaluation in parallel with the LIMIT randomised trial. Women with a singleton pregnancy, between 10+0-20+0 weeks, and BMI ≥25 kg/m2 were randomised to Lifestyle Advice (a comprehensive antenatal dietary and lifestyle intervention) or Standard Care. The economic evaluation took the perspective of the health care system and its patients, and compared costs encountered from the additional use of resources from time of randomisation until six weeks postpartum. Increments in health outcomes for both the woman and infant were considered in the cost-effectiveness analysis. Mean costs and effects in the treatment groups allocated at randomisation were compared, and incremental cost effectiveness ratios (ICERs) and confidence intervals (95%) calculated. Bootstrapping was used to confirm the estimated confidence intervals, and to generate acceptability curves representing the probability of the intervention being cost-effective at alternative monetary equivalent values for the outcomes avoiding high infant birth weight, and respiratory distress syndrome. Analyses utilised intention to treat principles. Results Overall, the increase in mean costs associated with providing the intervention was offset by savings associated with improved immediate neonatal outcomes, rendering the intervention cost neutral (Lifestyle Advice Group $11261.19±$14573.97 versus Standard Care Group $11306.70±$14562.02; p=0.094). Using a monetary value of $20,000 as a threshold value for avoiding an additional infant with birth weight above 4 kg, the probability that the antenatal intervention is cost-effective is 0.85, which increases to 0.95 when the threshold monetary value increases to $45,000. Conclusions Providing an antenatal dietary and lifestyle intervention for pregnant women who are overweight or obese is not associated with increased costs or cost savings, but is associated with a high probability of cost effectiveness. Ongoing participant follow-up into childhood is required to determine the medium to long-term impact of the observed, short-term endpoints, to more accurately estimate the value of the intervention on risk of obesity, and associated costs and health outcomes.
    Full-text · Article · Mar 2015

Publication Stats

9k Citations
2,004.43 Total Impact Points

Institutions

  • 1993-2016
    • University of Adelaide
      • • School of Paediatrics and Reproductive Health
      • • Discipline of Obstetrics and Gynaecology
      Tarndarnya, South Australia, Australia
  • 2012-2015
    • University of Auckland
      • Liggins Institute
      Окленд, Auckland, New Zealand
    • Academisch Medisch Centrum Universiteit van Amsterdam
      Amsterdamo, North Holland, Netherlands
  • 2013
    • La Trobe University
      • Faculty of Health Sciences
      Melbourne, Victoria, Australia
  • 2006-2012
    • United Nations Development Programme
      New York, New York, United States
  • 2008
    • Western Sydney University
      • Centre for Complementary Medicine Research (CompleMED)
      Penrith, New South Wales, Australia
  • 2005
    • Royal Adelaide Hospital
      Tarndarnya, South Australia, Australia
  • 2004
    • University of South Australia
      • School of Health Sciences
      Tarndarnya, South Australia, Australia
  • 2001
    • McMaster University
      • Department of Obstetrics and Gynaecology
      Hamilton, Ontario, Canada
    • Women`s and Children`s Hospital
      Tarndarnya, South Australia, Australia
  • 1995
    • University of Wollongong
      City of Greater Wollongong, New South Wales, Australia