Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002028280
Ethics application status
Approved
Date submitted
11/10/2018
Date registered
18/12/2018
Date last updated
12/12/2022
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
8/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The C*STEROID Feasibility Study: a two-site, randomised placebo controlled trial of corticosteroids before planned caesarean section delivery at 35+0 to 39+6 weeks of pregnancy to determine feasibility for recruitment to the C*STEROID Trial.
Scientific title
The C*STEROID Feasibility Study: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks
Secondary ID [1] 296308 0
Nil
Universal Trial Number (UTN)
U1111-1222-1430
Trial acronym
C*STEROID Feasibility Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean section delivery 310013 0
Respiratory distress syndrome 310014 0
Transient tachypnoea of the newborn 310015 0
Neonatal hypoglycaemia 310016 0
Condition category
Condition code
Respiratory 308771 308771 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 309404 309404 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.
Intervention code [1] 312638 0
Prevention
Comparator / control treatment
0.9% NaCl in a visually matching syringe.
Control group
Placebo

Outcomes
Primary outcome [1] 307750 0
Trial recruitment rate: number recruited/number of eligible participants.
Timepoint [1] 307750 0
Six and twelve months after commencing recruitment.
Secondary outcome [1] 352779 0
To identify which women (by gestational age and indication for delivery) are willing to participate in a randomised trial of corticosteroid use prior to planned CS at 35+0 to 39+6 weeks. Assessed by participant questionnaire and participant demographics (pregnancy and delivery information via data collection forms).
Timepoint [1] 352779 0
Six and twelve months after commencing recruitment.
Secondary outcome [2] 352780 0
To identify the duration of follow up that participants are willing to agree to via completion of a study-specific questionnaire.
Timepoint [2] 352780 0
Six and twelve months after commencing recruitment.
Secondary outcome [3] 352781 0
To identify the type of follow up that participants are willing to agree to via completion of a study-specific questionnaire.
Timepoint [3] 352781 0
Six and twelve months after commencing recruitment.
Secondary outcome [4] 352782 0
To identify the reasons why women may decline to participate in such a trial. This will be assessed via a study specific questionnaire.
Timepoint [4] 352782 0
Six and twelve months after commencing recruitment.
Secondary outcome [5] 352783 0
To identify the barriers and enablers to trial participation by participant via a study specific questionnaire.
Timepoint [5] 352783 0
Six and twelve months after commencing recruitment.
Secondary outcome [6] 353058 0
To identify the barriers and enablers to trial participation by research staff, medical professional and recruiting site status via focus group interviews.
Timepoint [6] 353058 0
Six and twelve months after commencing recruitment.
Secondary outcome [7] 353059 0
To accurately assess the feasibility of undertaking serial measurements of neonatal blood glucose concentrations. This will be assessed by the proportion of recruited mothers and babies who have blood sugar testing performed in accordance with trial protocol.
Timepoint [7] 353059 0
Six and twelve months after commencing recruitment.
Secondary outcome [8] 353060 0
Incidence of respiratory distress requiring >60 minutes of respiratory support. Including 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). (Safety/efficacy outcome)
Assessed by hospital records.
Timepoint [8] 353060 0
At the end of recruitment.
Secondary outcome [9] 353061 0
Incidence of hypoglycaemia (blood glucose level <2.6mmol/L) prior to primary hospital discharge. (Safety/efficacy outcome). Neonatal pre-feed blood glucose concentrations will be measured using a glucose oxidase method point-of-care device (e.g. i-STAT monitor) with levels measured at 1-2 hours of age after first feed, and then pre-feed 3-4 hourly until 12 hours of age. Any additional clinically indicated blood glucose levels recorded prior to primary hospital discharge will also be collected.
Timepoint [9] 353061 0
At the end of recruitment.

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.
Minimum age
14 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diabetes: pre-existing or gestational.
2. Non-viable fetus or major fetal abnormality.
3. Prior corticosteroid use in this 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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to COVID-19 and New Zealand’s Alert level 3/4 status we have the C*STEROID Feasibility Study to further recruitment. Recruitment was closed on 25th March 2020. We were able to recruit for 9 months of the planned 12 months of recruitment to this feasibility study and all aims and objectives will be achieved despite earlier than expected termination of recruitment.
Date of first participant enrolment
Anticipated
4/06/2019
Actual
21/06/2019
Date of last participant enrolment
Anticipated
31/05/2020
Actual
17/03/2020
Date of last data collection
Anticipated
28/04/2020
Actual
29/04/2020
Sample size
Target
400
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 20914 0
New Zealand
State/province [1] 20914 0

Funding & Sponsors
Funding source category [1] 300904 0
University
Name [1] 300904 0
University of Auckland FRDF - Liggins New Staff Research Fund
Country [1] 300904 0
New Zealand
Funding source category [2] 300911 0
Charities/Societies/Foundations
Name [2] 300911 0
Hugo Charitable Trust
Country [2] 300911 0
New Zealand
Funding source category [3] 304274 0
Charities/Societies/Foundations
Name [3] 304274 0
Cure Kids
Country [3] 304274 0
New Zealand
Funding source category [4] 304275 0
Charities/Societies/Foundations
Name [4] 304275 0
Lottery Health Research
Country [4] 304275 0
New Zealand
Primary sponsor type
University
Name
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] 300470 0
None
Name [1] 300470 0
Address [1] 300470 0
Country [1] 300470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301674 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 301674 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301674 0
New Zealand
Date submitted for ethics approval [1] 301674 0
01/11/2018
Approval date [1] 301674 0
31/01/2019
Ethics approval number [1] 301674 0

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 planned to be 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. The C*STEROID Feasibility Study will take place in two maternity units over a 12 month period to identify key issues that may arise for women considering trial participation and for the researchers and medical professionals involved in the trial in practice. The hypothesis of the C*STEROID Feasibility Study is that women will be willing to take part in a trial of antenatal corticosteroids prior to planned caesarean section at 35+0 to 39+6 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87742 0
A/Prof Katie Groom
Address 87742 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 87742 0
New Zealand
Phone 87742 0
+64 9 373 7599 ext 89823
Fax 87742 0
Email 87742 0
[email protected]
Contact person for public queries
Name 87743 0
A/Prof Katie Groom
Address 87743 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 87743 0
New Zealand
Phone 87743 0
+64 9 373 7599 ext 89823
Fax 87743 0
Email 87743 0
[email protected]
Contact person for scientific queries
Name 87744 0
A/Prof Katie Groom
Address 87744 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 87744 0
New Zealand
Phone 87744 0
+64 9 373 7599 ext 89823
Fax 87744 0
Email 87744 0
[email protected]

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: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5678Study protocolhttps://doi.org/10.5281/zenodo.3239556  



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes CHAN J, Mackay L, Bloomfield F, et al Corticostero... [More Details]
Plain language summaryNo This study was done as the first stage of a larger... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCorticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.2022https://dx.doi.org/10.1136/bmjopen-2022-062309
N.B. These documents automatically identified may not have been verified by the study sponsor.