Pat Ashwood
University of Adelaide
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BMC Pregnancy and Childbirth | 2013
Caroline A Crowther; Jane E. Harding; Philippa Middleton; Chad Andersen; Pat Ashwood; Jeffrey S. Robinson
AbstractBackgroundBoth 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/DesignDesign 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).DiscussionThis 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 registrationTrial registration number: ACTRN12608000631303
BMC Pregnancy and Childbirth | 2013
Caroline A Crowther; Philippa Middleton; Emily Bain; Pat Ashwood; Tanya Bubner; Vicki Flenady; Jonathan M. Morris; Sarah McIntyre
BackgroundBabies 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/DesignThe 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).DiscussionThe 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.
Pediatrics | 2016
Caroline A Crowther; Peter Anderson; Christopher J.D. McKinlay; Jane E. Harding; Pat Ashwood; Ross Haslam; Jeffery S. Robinson; Lex W. Doyle
OBJECTIVE: To assess if exposure to repeat dose(s) of antenatal corticosteroids has beneficial effects on neurodevelopment and general health in mid-childhood, at 6 to 8 years’ corrected age. METHODS: Women at risk for very preterm birth, who had received a course of corticosteroids ≥7 days previously, were randomized to intramuscular betamethasone (11.4 mg Celestone Chronodose) or saline placebo, repeated weekly if risk of very preterm birth remained. Mid-childhood assessments included neurocognitive function, behavior, growth, lung function, blood pressure, health-related quality of life, and health service utilization. The primary outcome was survival free of neurosensory disability. RESULTS: Of the 1059 eligible long-term survivors, 963 (91%) were included in the primary outcome; 479 (91%) in the repeat corticosteroid group and 484 (91%) in the placebo group. The rate of survival free of neurosensory disability was similar in both groups (78.3% repeat versus 77.3% placebo; risk ratio 1.00, 95% confidence interval, 0.94–1.08). Neurodevelopment, including cognitive function, and behavior, body size, blood pressure, spirometry, and health-related quality of life were similar in both groups, as was the use of health services. CONCLUSIONS: Treatment with repeat dose(s) of antenatal corticosteroids was associated with neither benefit nor harm in mid-childhood. Our finding of long-term safety supports the use of repeat dose(s) of antenatal corticosteroids, in view of the related neonatal benefits. For women at risk for preterm birth before 32 weeks’ gestation, ≥7 days after an initial course of antenatal corticosteroids, clinicians could consider using a single injection of betamethasone, repeated weekly if risk remains.
BMC Pregnancy and Childbirth | 2012
Caroline A Crowther; William M. Hague; Philippa Middleton; Peter Baghurst; Andrew J. McPhee; Thach S. Tran; Lisa N. Yelland; Pat Ashwood; Shan Han; Jodie M Dodd; Jeffrey S. Robinson
AbstractBackgroundThe 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.Methods/designDesign: 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.DiscussionA conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants.Trial registrationAustralian New Zealand Clinical Trials Registry - ACTRN12607000174482
British Journal of Obstetrics and Gynaecology | 2014
Emily Bain; Philippa Middleton; Lisa N. Yelland; Pat Ashwood; Caroline A Crowther
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.
Australian & New Zealand Journal of Obstetrics & Gynaecology | 2007
Jodie M Dodd; Pat Ashwood; Vicki Flenady; Sue Jenkins-Manning; Rob Cincotta; Caroline A Crowther
Background and aims: To assess the current use of vaginal progesterone in women at increased risk of preterm birth among practitioners within Australia and New Zealand, and the willingness of both clinicians and women to participate in a randomised controlled trial to further evaluate the role of progesterone in preterm birth.
Australian & New Zealand Journal of Obstetrics & Gynaecology | 2013
Emily Bain; Tanya Bubner; Pat Ashwood; Caroline A Crowther; Philippa Middleton
Health professionals at 25 Australian and New Zealand tertiary maternity hospitals were surveyed about local implementation of a clinical practice guideline for antenatal magnesium sulphate for fetal neuroprotection. Seventy‐six percent of respondents reported that their hospital is currently following a guideline; 36% confirmed that their hospital is auditing uptake. Estimates of uptake ranged from 53 to 90%. Ongoing education and support are needed to ensure that the guidelines are optimally implemented, and uptake and important health outcomes are monitored.
PLOS Medicine | 2017
Caroline A. Crowther; Pat Ashwood; Andrew J. McPhee; Vicki Flenady; Thach S. Tran; Jodie M Dodd; Jeffrey S. Robinson
Background Neonatal respiratory distress syndrome, as a consequence of preterm birth, is a major cause of early mortality and morbidity. The withdrawal of progesterone, either actual or functional, is thought to be an antecedent to the onset of labour. There remains limited information on clinically relevant health outcomes as to whether vaginal progesterone may be of benefit for pregnant women with a history of a previous preterm birth, who are at high risk of a recurrence. Our primary aim was to assess whether the use of vaginal progesterone pessaries in women with a history of previous spontaneous preterm birth reduced the risk and severity of respiratory distress syndrome in their infants, with secondary aims of examining the effects on other neonatal morbidities and maternal health and assessing the adverse effects of treatment. Methods Women with a live singleton or twin pregnancy between 18 to <24 weeks’ gestation and a history of prior preterm birth at less than 37 weeks’ gestation in the preceding pregnancy, where labour occurred spontaneously or in association with cervical incompetence or following preterm prelabour rupture of the membranes, were eligible. Women were recruited from 39 Australian, New Zealand, and Canadian maternity hospitals and assigned by randomisation to vaginal progesterone pessaries (equivalent to 100 mg vaginal progesterone) (n = 398) or placebo (n = 389). Participants and investigators were masked to the treatment allocation. The primary outcome was respiratory distress syndrome and severity. Secondary outcomes were other respiratory morbidities; other adverse neonatal outcomes; adverse outcomes for the woman, especially related to preterm birth; and side effects of progesterone treatment. Data were analysed for all the 787 women (100%) randomised and their 799 infants. Findings Most women used their allocated study treatment (740 women, 94.0%), with median use similar for both study groups (51.0 days, interquartile range [IQR] 28.0–69.0, in the progesterone group versus 52.0 days, IQR 27.0–76.0, in the placebo group). The incidence of respiratory distress syndrome was similar in both study groups—10.5% (42/402) in the progesterone group and 10.6% (41/388) in the placebo group (adjusted relative risk [RR] 0.98, 95% confidence interval [CI] 0.64–1.49, p = 0.912)—as was the severity of any neonatal respiratory disease (adjusted treatment effect 1.02, 95% CI 0.69–1.53, p = 0.905). No differences were seen between study groups for other respiratory morbidities and adverse infant outcomes, including serious infant composite outcome (155/406 [38.2%] in the progesterone group and 152/393 [38.7%] in the placebo group, adjusted RR 0.98, 95% CI 0.82–1.17, p = 0.798). The proportion of infants born before 37 weeks’ gestation was similar in both study groups (148/406 [36.5%] in the progesterone group and 146/393 [37.2%] in the placebo group, adjusted RR 0.97, 95% CI 0.81–1.17, p = 0.765). A similar proportion of women in both study groups had maternal morbidities, especially those related to preterm birth, or experienced side effects of treatment. In 9.9% (39/394) of the women in the progesterone group and 7.3% (28/382) of the women in the placebo group, treatment was stopped because of side effects (adjusted RR 1.35, 95% CI 0.85–2.15, p = 0.204). The main limitation of the study was that almost 9% of the women did not start the medication or forgot to use it 3 or more times a week. Conclusions Our results do not support the use of vaginal progesterone pessaries in women with a history of a previous spontaneous preterm birth to reduce the risk of neonatal respiratory distress syndrome or other neonatal and maternal morbidities related to preterm birth. Individual participant data meta-analysis of the relevant trials may identify specific women for whom vaginal progesterone might be of benefit. Trial registration Current Clinical Trials ISRCTN20269066.
The Journal of Pediatrics | 2018
Matthew J. Glasgow; Jane E. Harding; Richard Edlin; Jane M. Alsweiler; J. Geoffery Chase; Deborah L. Harris; Benjamin Thompson; Trecia A. Wouldes; Judith M. Ansell; Anne Jaquiery; Kelly Jones; Sapphire Martin; Christina McQuoid; Jenny Rogers; Heather Stewart; Anna Catherine Tottman; Kate Williamson; Ellen Campbell; Coila Bevan; Tineke J Crawford; Kelly Fredell; Kate Sommers; Claire Hahnhaussen; Safayet Hossin; Karen Frost; Grace McKnight; Janine Paynter; Jess Wilson; R P Young; Anna Gsell
Objective To evaluate the costs of using dextrose gel as a primary treatment for neonatal hypoglycemia in the first 48 hours after birth compared with standard care. Study design We used a decision tree to model overall costs, including those specific to hypoglycemia monitoring and treatment and those related to the infants length of stay in the postnatal ward or neonatal intensive care unit, comparing the use of dextrose gel for treatment of neonatal hypoglycemia with placebo, using data from the Sugar Babies randomized trial. Sensitivity analyses assessed the impact of dextrose gel cost, neonatal intensive care cost, cesarean delivery rate, and costs of glucose monitoring. Results In the primary analysis, treating neonatal hypoglycemia using dextrose gel had an overall cost of NZ
Cochrane Database of Systematic Reviews | 2011
Andrea R Deussen; Pat Ashwood; Ruth Martis
6863.81 and standard care (placebo) cost NZ