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Trial registered on ANZCTR


Registration number
ACTRN12620000914965
Ethics application status
Approved
Date submitted
25/06/2020
Date registered
16/09/2020
Date last updated
3/05/2021
Date data sharing statement initially provided
16/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The C*STEROID Trial: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy.
Scientific title
The C*STEROID Trial. Antenatal corticosteroids prior to planned caesarean section delivery from 35+0 to 39+6 weeks gestation; a randomised controlled trial assessing the effects on neonatal respiratory morbidity and glycaemic control.
Secondary ID [1] 301624 0
None
Universal Trial Number (UTN)
U1111-1254-2168
Trial acronym
The C*STEROID Trial
Linked study record
ACTRN12618002028280. This record is the C*STEROID Feasibility Study a pilot study of this study with participant data contributing to The C*STEROID Trial.

Health condition
Health condition(s) or problem(s) studied:
Caesarean section delivery 318015 0
Respiratory distress syndrome 318016 0
Transient tachypnoea of the newborn 318017 0
Neonatal hypoglycaemia 318018 0
Condition category
Condition code
Respiratory 316042 316042 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 316043 316043 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two doses of 11.4mg betamethasone by intramuscular injection into the thigh, arm or buttock, 24 hours apart given within seven days of planned caesarean section. Adherence will be assessed by review of the drug accountability log and/or medication chart.
Intervention code [1] 317926 0
Prevention
Comparator / control treatment
0.9% sodium chloride (NaCl) in a visually matching syringe.
Control group
Placebo

Outcomes
Primary outcome [1] 324254 0
Incidence of respiratory distress requiring >60 minutes of respiratory support (neonatal outcome). Includes mechanical and non-invasive ventilation where sum of both is >60 minutes (e.g. intermittent positive pressure via endotracheal tube, nasal continuous positive airway pressure, Hi- or Lo-flow oxygen/air mix or increased ambient oxygen delivered into an incubator). >60 minutes has been selected to eliminate short-term support which may be subject to variation by clinician. Data will be collected by review of hospital/neonatal unit records.
Timepoint [1] 324254 0
Primary hospital discharge
Primary outcome [2] 324255 0
Incidence of neonatal hypoglycaemia (blood glucose level <2.6 mmol/L) prior to primary hospital discharge. Data will be collected by review of hospital records and/or glucose oxidase test results.
Timepoint [2] 324255 0
Primary hospital discharge
Secondary outcome [1] 384177 0
Neonatal Unit (NNU) admission assessed by review of hospital/neonatal unit medical records.
Timepoint [1] 384177 0
Primary hospital discharge
Secondary outcome [2] 384178 0
Duration of Neonatal Unit (NNU) stay assessed by review of hospital/neonatal unit medical records.
Timepoint [2] 384178 0
Primary hospital discharge
Secondary outcome [3] 384179 0
Duration of neonatal hospital stay (to primary hospital discharge) assessed by review of hospital medical records.
Timepoint [3] 384179 0
Primary hospital discharge
Secondary outcome [4] 384180 0
Duration of respiratory support (sum of mechanical and non-invasive) (neonatal outcome). Data will be collected from hospital medical records.
Timepoint [4] 384180 0
Primary hospital discharge
Secondary outcome [5] 384181 0
A composite outcome of severe respiratory distress defined as any mechanical ventilation and/or need for surfactant therapy (neonatal outcome). Data will be collected from hospital medical records.
Timepoint [5] 384181 0
Primary hospital discharge
Secondary outcome [6] 384182 0
Severe hypoglycaemia defined as blood glucose level <1.2 mmol/L (neonatal outcome). Data will be collected by review of hospital records and/or glucose oxidase test results.
Timepoint [6] 384182 0
Primary hospital discharge
Secondary outcome [7] 384183 0
Early onset infection and/or late onset infection as defined by the Australian and New Zealand Neonatal Network (ANZNN). Data will be collected from hospital medical records.
Timepoint [7] 384183 0
Primary hospital discharge
Secondary outcome [8] 384184 0
Maternal self-reported adverse effects of injections including gastrointestinal upset; insomnia; pain, bruising or infection at injection site. Data will be collected from hospital records and study-specific surveys.
Timepoint [8] 384184 0
Primary hospital discharge
Secondary outcome [9] 384185 0
Maternal perinatal infectious morbidity requiring postpartum antibiotic therapy. Data will be collected from a study-specific survey and if required additional details will be obtained from the hospital records, prescription records, study-specific surveys and GP/LMC records.
Timepoint [9] 384185 0
Six weeks postpartum
Secondary outcome [10] 384186 0
Duration of maternal postnatal stay (to primary hospital discharge). Data will be collected from hospital medical records.
Timepoint [10] 384186 0
Primary hospital discharge
Secondary outcome [11] 384187 0
Breastfeeding (exclusive and full) at six weeks postpartum. This will be collected from a study-specific survey.
Timepoint [11] 384187 0
Six weeks postpartum
Secondary outcome [12] 384188 0
Maternal wellbeing and psychological status measured at six weeks postpartum.This will be collected from a study-specific survey and the Edinburgh Postnatal Depression Scale.
Timepoint [12] 384188 0
Six weeks postpartum
Secondary outcome [13] 384884 0
Moderate respiratory distress defined as respiratory support (sum of mechanical and non-invasive) for >24 hours (neonatal outcome). Data will be collected from hospital medical records.
Timepoint [13] 384884 0
Primary hospital discharge

Eligibility
Key inclusion criteria
1. Women for whom caesarean section is planned pre-labour at 35+0 to 39+6 weeks gestation.
2. >24 hours and <7 days before planned birth.
3. Singleton or twin pregnancy with a live fetus.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diabetes: pre-existing or gestational.
2. Major fetal abnormality.
3. Prior corticosteroid use in this pregnancy (intramuscular corticosteroid use for fetal lung maturity).
4. Prior enrolment in the C*STEROID Feasibility Study or C*STEROID Trial, in a previous pregnancy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 22694 0
New Zealand
State/province [1] 22694 0

Funding & Sponsors
Funding source category [1] 306055 0
Government body
Name [1] 306055 0
Health Research Council of New Zealand (HRC)
Address [1] 306055 0
Level 3, ProCare Building, 110 Stanley Street, Auckland 1010, New Zealand
Country [1] 306055 0
New Zealand
Funding source category [2] 306056 0
Charities/Societies/Foundations
Name [2] 306056 0
Cure Kids
Address [2] 306056 0
96 New North Road, Eden Terrace, Auckland 1021
Country [2] 306056 0
New Zealand
Funding source category [3] 306057 0
Charities/Societies/Foundations
Name [3] 306057 0
Lottery Health Research
Address [3] 306057 0
The Department of Internal Affairs: Community Operations, 7 Ronwood Avenue, Manukau
Auckland 2104
Country [3] 306057 0
New Zealand
Funding source category [4] 306058 0
Charities/Societies/Foundations
Name [4] 306058 0
The Hugo Charitable Trust
Address [4] 306058 0
Level 3, General Buildings
29-33 Shortland Street
Auckland 1143
New Zealand
Country [4] 306058 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Liggins Institute
The University of Auckland
85 Park Road
Private Bag 92019
Grafton
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 306519 0
None
Name [1] 306519 0
Address [1] 306519 0
Country [1] 306519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306281 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 306281 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306281 0
New Zealand
Date submitted for ethics approval [1] 306281 0
21/07/2020
Approval date [1] 306281 0
28/09/2020
Ethics approval number [1] 306281 0
20/NTB/166

Summary
Brief summary
Birth by planned caesarean section poses some risk to babies, in particular, the need for admission to the neonatal unit for breathing support. Corticosteroid injections given to mothers expecting a preterm birth reduce neonatal respiratory morbidity but is not known if corticosteroids before a planned caesarean section at or near term have the same effect. Limited research suggests that as well as benefits on babies’ breathing these injections may lower babies’ blood sugar levels and so possibly cause harm. The C*STEROID Trial is a multi-centre, placebo-controlled, randomised trial to assess the effects of corticosteroids given to mothers before a planned caesarean section at or near term on neonatal and childhood health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103354 0
A/Prof Katie Groom
Address 103354 0
Associate Professor of Maternal and Perinatal Health
Hugo Charitable Trust Research Fellow
Maternal Fetal Medicine Subspecialist
The University of Auckland, 85 Park Road, Grafton
Private Bag 92019, Auckland 1142
Country 103354 0
New Zealand
Phone 103354 0
+64 9 3737599
Fax 103354 0
Email 103354 0
k.groom@auckland.ac.nz
Contact person for public queries
Name 103355 0
A/Prof Katie Groom
Address 103355 0
Associate Professor of Maternal and Perinatal Health
Hugo Charitable Trust Research Fellow
Maternal Fetal Medicine Subspecialist
The University of Auckland, 85 Park Road, Grafton
Private Bag 92019, Auckland 1142
Country 103355 0
New Zealand
Phone 103355 0
+64 9 3737599
Fax 103355 0
Email 103355 0
k.groom@auckland.ac.nz
Contact person for scientific queries
Name 103356 0
A/Prof Katie Groom
Address 103356 0
Associate Professor of Maternal and Perinatal Health
Hugo Charitable Trust Research Fellow
Maternal Fetal Medicine Subspecialist
The University of Auckland, 85 Park Road, Grafton
Private Bag 92019, Auckland 1142
Country 103356 0
New Zealand
Phone 103356 0
+64 9 3737599
Fax 103356 0
Email 103356 0
k.groom@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results.
When will data be available (start and end dates)?
Immediately following publication which is anticipated to occur after 2024, no end date determined.
Available to whom?
The de-identified data that support the findings of this study will be made available upon request to researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Available for what types of analyses?
Any purpose which has received approval from an independent review committee, and is approved by the Trial Steering Committee.
How or where can data be obtained?
Access subject to approvals by Trial Steering Committee. Contact via Katie Groom: k.groom@auckland.ac.nz
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 8339 0
Study protocol
Citation [1] 8339 0
Link [1] 8339 0
Email [1] 8339 0
k.groom@auckland.ac.nz
Other [1] 8339 0
Attachment [1] 8339 0
Summary results
No Results