Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000282886
Ethics application status
Approved
Date submitted
28/02/2012
Date registered
9/03/2012
Date last updated
30/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fetal cardiovascular response to maternal corticosteroid administration: a comparison of dexamethasone versus betamethasone
Scientific title
Fetal cardiovascular response to maternal corticosteroid administration for fetal lung maturity: an observational comparison of dexamethasone versus betamethasone ultrasound and cardiotocograph effects within the A*STEROID randomised controlled trial
Secondary ID [1] 280048 0
Nil
Universal Trial Number (UTN)
U1111-1128-6330
Trial acronym
SUPER-A*STEROID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal cardiovascular status, and its correlation with neonatal outcome and long-term childhood neurosensory disability, following antenatal corticosteroids given to women at risk of preterm birth at less than 34 weeks gestation 285962 0
Condition category
Condition code
Reproductive Health and Childbirth 286147 286147 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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. (Performed as part of parent A*STEROID trial, ACTRN 12608000631303 - drugs not administered by this trial's investigators)

Observational component: Fetal cardiovascular and behavioural effects of corticosteroids (as measured by ultrasound and cardiotocograph) in the first week after maternal corticosteroid administration. Correlation with neonatal and early childhood outcome.
Intervention code [1] 284372 0
Not applicable
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. (Performed as part of parent A*STEROID trial, ACTRN 12608000631303 - drugs not administered by this trial's investigators)
Control group
Active

Outcomes
Primary outcome [1] 286619 0
Fetal middle cerebral artery pulsatility index measurement as measured by Doppler ultrasound.
Timepoint [1] 286619 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Primary outcome [2] 286620 0
Fetal heart rate short term-variability on cardiotocograph.
Timepoint [2] 286620 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [1] 296280 0
Fetal umbilical artery pulsatility index measurement as measured by Doppler ultrasound.
Timepoint [1] 296280 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [2] 296281 0
Fetal umbilical artery resistive index measurement as measured by Doppler ultrasound.
Timepoint [2] 296281 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [3] 296282 0
Fetal myocardial performance index measurement as measured by Doppler ultrasound.
Timepoint [3] 296282 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [4] 296283 0
Fetal middle cerebral artery peak systolic volume measurement as measured by Doppler ultrasound.
Timepoint [4] 296283 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [5] 296284 0
Maternal uterine artery pulsatility index measurement as measured by Doppler ultrasound.
Timepoint [5] 296284 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [6] 296285 0
Fetal ductus venosus waveform measurement as measured by Doppler ultrasound.
Timepoint [6] 296285 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [7] 296286 0
Fetal biophysical profile score (standardised ultrasound measure).
Timepoint [7] 296286 0
Baseline (prior to corticosteroid administration), 24 hours (range 18-30 hours), 48 hours (range 42-54 hours), 96 hours (range 3-5 days), 7 days (range 7-10 days, prior to any repeat dose corticosteroid).
Secondary outcome [8] 296287 0
Umbilical arterial cord pH <7.20
Timepoint [8] 296287 0
As measured after birth
Secondary outcome [9] 296288 0
Placental weight >90th centile for gestation
Timepoint [9] 296288 0
As measured after birth
Secondary outcome [10] 296289 0
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 [10] 296289 0
At hospital discharge
Secondary outcome [11] 296290 0
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 [11] 296290 0
At 2 years corrected age

Eligibility
Key inclusion criteria
Women are eligible for the trial if they are at risk of preterm birth at less than 34 weeks gestation, are aged 18-50, have a singleton or twin pregnancy, have no contraindications to the use of antenatal corticosteroids and give informed consent to both the A*STEROID trial and this trial.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
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, are in the second stage of labour, have an abnormal morphology scan, are taking digoxin or pure beta-blocker, have psychiatric illness precluding informed consent, or have insufficient English for valid consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2012
Actual
23/02/2012
Date of last participant enrolment
Anticipated
Actual
31/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5316 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 5317 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 5031 0
2031
Recruitment postcode(s) [2] 5032 0
2217

Funding & Sponsors
Funding source category [1] 284801 0
Charities/Societies/Foundations
Name [1] 284801 0
Australasian Society of Ultrasound in Medicine
Country [1] 284801 0
Australia
Primary sponsor type
Individual
Name
Dr Amanda Henry
Address
School of Women's and Children's Health
University of New South Wales
Level 1, Royal Hospital for Women,
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 283683 0
Individual
Name [1] 283683 0
Professor Alec Welsh
Address [1] 283683 0
Professor of Maternal-Fetal Medicine
School of Women's and Children's Health
University of New South Wales
Level 1, Royal Hospital for Women,
Randwick
NSW 2031
Country [1] 283683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286789 0
South Eastern Sydney Local Health District HREC - Northern Sector
Ethics committee address [1] 286789 0
Room G71 East Wing
Edmund Blackett Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 286789 0
Australia
Date submitted for ethics approval [1] 286789 0
Approval date [1] 286789 0
23/01/2012
Ethics approval number [1] 286789 0
1/11/0202

Summary
Brief summary
The primary aims of the trial are (within the context of the RCT A*STEROID)
1) To evaluate the effects of betamethasone and dexamethasone on fetal cardiovascular status as assessed by the ultrasound parameters of umbilical artery Doppler, middle cerebral artery Doppler, ductus venosus Doppler, uterine artery Doppler, and myocardial performance index.
2) To evaluate the effects of betamethasone and dexamethasone on fetal cardiovascular status as assessed by computerized cardiotocograph (cCTG) using Dawes-Redman criteria.
3) To evaluate the effects of betamethasone and dexamethasone on placental weight, morphology and histological evidence of villous maturation postpartum, and correlate this with placental ultrasound and uterine artery Doppler findings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33850 0
Dr Amanda Henry
Address 33850 0
School of Women's and Children's Health, UNSW
Level 1, Royal Hospital for Women
Barker St (Locked Bag 2000),
Randwick, NSW 2031
Country 33850 0
Australia
Phone 33850 0
+61 2 91132315
Fax 33850 0
Email 33850 0
amanda.henry@unsw.edu.au
Contact person for public queries
Name 17097 0
Dr Dr Amanda Henry
Address 17097 0
School of Women's and Children's Health
University of New South Wales
Level 1, Royal Hospital for Women
Randwick NSW 2031
Country 17097 0
Australia
Phone 17097 0
+61 2 91132315
Fax 17097 0
+61 2 9382 6444
Email 17097 0
Amanda.Henry@unsw.edu.au
Contact person for scientific queries
Name 8025 0
Dr Dr Amanda Henry
Address 8025 0
School of Women's and Children's Health
University of New South Wales
Level 1, Royal Hospital for Women
Randwick NSW 2031
Country 8025 0
Australia
Phone 8025 0
+61 2 91132315
Fax 8025 0
+61 2 9382 6444
Email 8025 0
Amanda.Henry@unsw.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

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