CompletedPhase 3ACTRN12608000631303

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


Sponsor

Women’s and Children’s Hospital, SA

Enrollment

1,499 participants

Start Date

Mar 5, 2009

Study Type

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

Sex: FemalesMin Age: 13 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for pregnant women aged 13 to 55 who are at risk of delivering their baby early (before 34 weeks) and are carrying one or two babies. It compares two types of steroid injections (dexamethasone versus betamethasone) given before preterm birth to help the baby's lungs develop and reduce the risk of disability.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 hou

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)

New Zealand

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ACTRN12608000631303