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Open Access Study protocol

Australasian 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 protocol

Caroline A Crowther12*, Jane E Harding2, Philippa F Middleton1, Chad C Andersen3, Pat Ashwood1, Jeffrey S Robinson1 and for the A*STEROID Study Group

Author Affiliations

1 Australian Research Centre for Health of Women and Babies (ARCH), The Robinson Institute, Discipline of Obstetrics and Gynaecology, Women’s & Children’s Hospital, The University of Adelaide, 72 King William Road, North Adelaide, South Australia, 5006, Australia

2 Liggins Institute, The University of Auckland, Auckland, New Zealand

3 Department of Perinatal Medicine, Women’s and Children’s Hospital, Adelaide, Australia

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BMC Pregnancy and Childbirth 2013, 13:104  doi:10.1186/1471-2393-13-104

Published: 3 May 2013

Abstract

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

Trial registration number: ACTRN12608000631303

Keywords:
Antenatal corticosteroids; Dexamethasone; Betamethasone; Preterm birth; Randomised controlled trial; Neurosensory disability