A*STEROID: Australian Antenatal Study To Evaluate the Role Of Intramuscular Desamethasone prior to preterm birth to increase survival free of childhood neurosensory disability.

This trial is currently recruiting.

Both dexamethasone or betamethasone, given to women at risk of preterm birth, substantially improve neonatal and child health. There are conflicting reports as to whether dexamethasone is better than betamethasone. This randomised trial will assess this.

Pregnant women with a singleton or twins at less than 34 weeks gestation with no contraindications to the use of antenatal corticosteroids and who give informed consent will be randomised to either dexamethasone or betamethasone, allocated a study number and corresponding treatment pack.
Each treatment pack looks identical and contains two opaque syringes of either 11.4 mg betamethasone (as Celestone Chronodose 11.4 mg) or 12 mgs dexamethasone (as sodium phosphate - a non-sulphite containing preparation).
The contents of each syringe are given to the women as an intramuscular injection, 24 hours apart. Details of the women's and baby's health will be collected.

The main study outcome is the risk of death or any neurosensory disability at 2 years' corrected age. The study will need to enrol 1499 women to detect statistically significant differences between the two corticosteroid treatment groups of 27% for betamethasone and 20.1% for dexamethasone as reported in the earlier synthesis of research.

If dexamethasone is more beneficial, there will be fewer babies who have an intraventricular haemorrhage which may lead to fewer disabled children. This will be of great importance for the care of women at risk of preterm birth, their children and health services in Australia and internationally.