Australasian Antenatal Study To Evaluate the Role Of Intramuscular Dexamethasone versus Betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability – a randomised controlled trial
Women’s and Children’s Hospital, SA
1,499 participants
Mar 5, 2009
Interventional
Conditions
Summary
The primary aim of this randomised controlled trial is to determine whether giving antenatal 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 2 years’ corrected age, compared with women given antenatal betamethasone. The primary hypothesis of the study is that, compared with betamethasone, antenatal dexamethasone given to women at risk of preterm birth (less than 34 weeks gestation) reduces the risk of death or any neurosensory disability, caused by impairments such as cerebral palsy, blindness, deafness or developmental delay, in their children at 2 years’ corrected age. Specific aims are to assess whether dexamethasone has greater short-term benefits than betamethasone (a greater reduction in the risk of intraventricular haemorrhage as suggested by a new systematic review) and whether there are longer-term effects on childhood neurological function, including motor function, cognition and behaviour, as well as body size, blood pressure and general health.
Eligibility
Inclusion Criteria1
- Women are eligible for the trial if they are at risk of preterm birth at less than 34 weeks gestation, have a singleton or twin pregnancy, have no contraindications to the use of antenatal corticosteroids and give informed consent.
Exclusion Criteria1
- Women are not eligible if they have chorioamnionitis requiring urgent delivery, a higher order multiple pregnancy, have already received antenatal corticosteroids, have known fetal lung maturation, or are in the second stage of labour.
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Interventions
Dexamethasone (antenatal corticosteroid) - 2 syringes of 12 mg dexamethasone (dexamethasone sodium phosphate - a non-sulphite containing preparation) administered as 2 intramuscular injections, 24 hours apart.
Locations(1)
View Full Details on ANZCTR
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ACTRN12608000631303