ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000631303

Ethics application status

Approved

Date submitted

12/11/2008

Date registered

12/12/2008

Date last updated

10/01/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

A*STEROID

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Long-term childhood neurosensory disability following antenatal corticosteroids given to women at risk of preterm birth at less than 34 weeks gestatation

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Betamethasone (antenatal corticosteroid) - 2 syringes of 11.4 mg betamethasone (as Celestone Chronodose 11.4 mg) administered as 2 intramuscular injections, 24 hours apart.

Control group

Active

Outcomes

Primary outcome [1]

Composite of incidence of death (defined as stillbirths, deaths from live born infants before hospital discharge and deaths after hospital discharge) or any neurosensory disability in the children (includes the neurosensory impairments of cerebral palsy, blindness, deafness and any developmental delay defined as a standardised score more than 1 SD below the mean (<-1SD)).

Timepoint [1]

At 2 years' corrected age.

Secondary outcome [1]

Composite of incidence of death or major neurosensory disability in the children (with major neurosensory disability defined as severe and moderate disability and includes blindness, deafness, cerebral palsy in a child non-ambulant by 2 years of age or a standardised score <-2SD).

Timepoint [1]

At 2 years' corrected age.

Secondary outcome [2]

Individual components and severity of the primary outcome (cerebral palsy, blindness, deafness, developmental delay).

Timepoint [2]

At 2 years' corrected age

Secondary outcome [3]

Neonatal outcomes including intraventricular haemorrahge (IVH), severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity needing treatment, patent ductus arteriosus needing treatment, use of inotropes, respiratory distress syndrome, severity of any neonatal lung disease, chronic lung disease (need for oxygen at 36 weeks post-menstrual age), use of mechanical ventilation, confirmed infection within the first 48 hours, infection after the first 48 hours, body size at birth (weight, length and head circumference) and at discharge home after birth

Timepoint [3]

At primary hospital discharge

Secondary outcome [4]

Childhood outcomes: developmental domains as measured by Ages & Stages Questionnaire (Bricker & Squires 1999)

Timepoint [4]

At 1 year corrected age

Secondary outcome [5]

Childhood outcomes: Body size and corresponding Z scores, General health of the child (including use of health services since primary hospitalisation), Childhood respiratory morbidity, Blood pressure Z scores and proportions in hypertensive ranges and Behaviour

Timepoint [5]

At 2 years corrected age

Secondary outcome [6]

Maternal perinatal infectious morbidity (defined as clinical chorioamnionitis requiring intrapartum antibiotics, use of postpartum antibiotics).

Timepoint [6]

Up to 6 weeks post hospital discharge

Eligibility

Key inclusion criteria

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.

Minimum age

13 Years

Maximum age

55 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligible women are counselled and must give signed, informed consent. Trial entry details are given and eligibility is confirmed, the woman is randomised by contacting the central telephone randomisation service at the University of Adelaide. Assignment to one of two treatment groups: either the dexamethasone group or the betamethasone group. A Study Number and a corresponding numbered treatment pack will be allocated.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation schedule will use balanced variable blocks and will be created using computer software (i.e., computerised sequence generation) by researchers not involved in clinical care. Assignment to either group will be stratified for collaborating centre, gestational age (<28 weeks, >= 28 weeks gestation), and number of fetuses (1 or 2).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2009

Actual

5/03/2009

Date of last participant enrolment

Anticipated

Actual

7/02/2013

Date of last data collection

Anticipated

Actual

30/09/2016

Sample size

Target

1499

Accrual to date

Final

1509

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,TAS

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Physical address:
Level 5, 20 Allara Street
Canberra ACT 2601

Postal address:
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Women’s and Children’s Hospital, SA

Address

72 King William Road,
North Adelaide
SA , 5006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children, Youth & Women's Health Service (CYWHS) Human Research Ethics Committee (HREC)

Ethics committee address [1]

Women's and Children's Hospital,
72 King William Road,
North Adelaide 
SA  
5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/10/2008

Ethics approval number [1]

REC2074/7/11

Summary

Brief 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.

Trial website

http://www.adelaide.edu.au/arch/research/clinical_trials/asteroid.html

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Caroline Crowther

Address

University of Adelaide Obstetrics & Gynaecology
Level 1, Queen Victoria Building
Women's and Children's Hospital
72 King William St
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

caroline.crowther@adelaide.edu.au

Contact person for public queries

Name

Ms Pat Ashwood

Address

Australian Research Centre for Health of Women and Babies (ARCH)
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide
South Australia 5006

Country

Australia

Phone

+61 8 8161 7767

Fax

+61 8 8161 7652

pat.ashwood@adelaide.edu.au

Contact person for scientific queries

Name

Professor Caroline Crowther

Address

University of Adelaide
Obstetrics & Gynaecology
Level 1, Queen Victoria Building
Women's and Children's Hospital
72 King William St
North Adelaide
SA
5006

Country

Australia

Phone

+61 8 8161 7647

Fax

+61 8 8161 7652

caroline.crowther@adelaide.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial.	2019	https://dx.doi.org/10.1016/S2352-4642%2819%2930292-5
Embase	Short-Term Effects of Dexamethasone versus Betamethasone on Ultrasonic Measures of Fetal Well-Being: Cohort from a Blinded, Randomized Trial.	2021	https://dx.doi.org/10.1159/000517623
Embase	Maternal and infant morbidity following administration of repeat dexamethasone or betamethasone prior to preterm birth: A secondary analysis of the ASTEROID Trial.	2022	https://dx.doi.org/10.1371/journal.pone.0263927

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically