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.
Author(s): Crowther CA(1), Harding JE, Middleton PF, Andersen CC, Ashwood P, Robinson JS;
A*STEROID Study Group.
Collaborators: Crowther CA, Harding JE, Middleton PF, Andersen CC, Ashwood P,
Robinson JS.
Affiliation(s): Author information:
(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. caroline.crowther@adelaide.edu.au
Publication date & source: 2013, BMC Pregnancy Childbirth. , 13:104
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.
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