ANZCTR - Registration

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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 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]

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

Respiratory distress syndrome

Transient tachypnoea of the newborn

Neonatal hypoglycaemia

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

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]

Prevention

Comparator / control treatment

0.9% NaCl in a visually matching syringe.

Control group

Placebo

Outcomes

Primary outcome [1]

Trial recruitment rate: number recruited/number of eligible participants.

Timepoint [1]

Six and twelve months after commencing recruitment.

Secondary outcome [1]

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]

Six and twelve months after commencing recruitment.

Secondary outcome [2]

To identify the duration of follow up that participants are willing to agree to via completion of a study-specific questionnaire.

Timepoint [2]

Six and twelve months after commencing recruitment.

Secondary outcome [3]

To identify the type of follow up that participants are willing to agree to via completion of a study-specific questionnaire.

Timepoint [3]

Six and twelve months after commencing recruitment.

Secondary outcome [4]

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]

Six and twelve months after commencing recruitment.

Secondary outcome [5]

To identify the barriers and enablers to trial participation by participant via a study specific questionnaire.

Timepoint [5]

Six and twelve months after commencing recruitment.

Secondary outcome [6]

To identify the barriers and enablers to trial participation by research staff, medical professional and recruiting site status via focus group interviews.

Timepoint [6]

Six and twelve months after commencing recruitment.

Secondary outcome [7]

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]

Six and twelve months after commencing recruitment.

Secondary outcome [8]

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]

At the end of recruitment.

Secondary outcome [9]

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]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland FRDF - Liggins New Staff Research Fund

Address [1]

Liggins Institute
The University of Auckland
85 Park Road
Private Bag 92019
Grafton
Auckland 1142
New Zealand

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Hugo Charitable Trust

Address [2]

PO Box 105-846
Auckland 1143
New Zealand

Country [2]

New Zealand

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Cure Kids

Address [3]

96 New North Road, Eden Terrace, Auckland 1021

Country [3]

New Zealand

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Lottery Health Research

Address [4]

The Department of Internal Affairs: Community Operations, 7 Ronwood Avenue, Manukau
Auckland 2104

Country [4]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
 Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/11/2018

Approval date [1]

31/01/2019

Ethics approval number [1]

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

A/Prof Katie Groom

Address

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

New Zealand

Phone

+64 9 373 7599 ext 89823

Fax

Email

k.groom@auckland.ac.nz

Contact person for public queries

Name

Katie Groom

Address

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

New Zealand

Phone

+64 9 373 7599 ext 89823

Fax

Email

k.groom@auckland.ac.nz

Contact person for scientific queries

Name

Katie Groom

Address

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

New Zealand

Phone

+64 9 373 7599 ext 89823

Fax

Email

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5678	Study protocol	https://doi.org/10.5281/zenodo.3239556

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	Corticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.	2022	https://dx.doi.org/10.1136/bmjopen-2022-062309

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