Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/78853
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dc.contributor.authorCrowther, C.en
dc.contributor.authorHarding, J.en
dc.contributor.authorMiddleton, P.en
dc.contributor.authorAndersen, C.en
dc.contributor.authorAshwood, P.en
dc.contributor.authorRobinson, J.en
dc.date.issued2013en
dc.identifier.citationBMC Pregnancy and Childbirth, 2013; 13(104):1-7en
dc.identifier.issn1471-2393en
dc.identifier.issn1471-2393en
dc.identifier.urihttp://hdl.handle.net/2440/78853-
dc.description.abstractBACKGROUND 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 Trial registration number: ACTRN12608000631303en
dc.description.statementofresponsibilityCaroline A Crowther, Jane E Harding, Philippa F Middleton, Chad C Andersen, Pat Ashwood, Jeffrey S Robinsonen
dc.language.isoenen
dc.publisherBioMed Central Ltd.en
dc.rights© 2013 Crowther et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.subjectAntenatal corticosteroids; Dexamethasone; Betamethasone; Preterm birth; Randomised controlled trial; Neurosensory disabilityen
dc.titleAustralasian randomised trial to evaluate the role of maternal intramuscular dexamethasone versus betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability (A*STEROID): Study protocolen
dc.typeJournal articleen
dc.identifier.rmid0020128925en
dc.identifier.doi10.1186/1471-2393-13-104en
dc.identifier.pubid19157-
pubs.library.collectionObstetrics and Gynaecology publicationsen
pubs.verification-statusVerifieden
pubs.publication-statusPublisheden
dc.identifier.orcidCrowther, C. [0000-0002-9079-4451]en
dc.identifier.orcidMiddleton, P. [0000-0002-8573-338X]en
dc.identifier.orcidRobinson, J. [0000-0002-4515-6039]en
Appears in Collections:Obstetrics and Gynaecology publications

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