Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001083684
Ethics application status
Approved
Date submitted
2/09/2014
Date registered
9/10/2014
Date last updated
30/07/2019
Date data sharing statement initially provided
30/07/2019
Date results information initially provided
30/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimisation of Glycaemic Control in the Setting of Antenatal Corticosteroid Administration in Pregnancies Complicated by Diabetes
Scientific title
Subcutaneous versus Intravenous Insulin Therapy for Glycaemic Control in the Setting of Antenatal Corticosteroid Administration in Pregnancies Complicated by Diabetes
Secondary ID [1] 285280 0
Nil
Universal Trial Number (UTN)
U1111-1161-1035
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes in pregnancy 292942 0
Condition category
Condition code
Metabolic and Endocrine 293239 293239 0 0
Diabetes
Reproductive Health and Childbirth 293430 293430 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subcutaneous insulin therapy titrated according to maternal blood glucose levels pre- and post-prandial and pre-bed in women with diabetes in pregnancy who receive antenatal corticosteroids for threatened preterm delivery. Subcutaneous insulin administration commenced at initial corticosteroid dose and continued until maternal blood glucose levels normalised, generally 48-72 hours following last corticosteroid dose.
Intervention code [1] 290170 0
Treatment: Drugs
Comparator / control treatment
Intravenous insulin therapy as per our established protocol titrated to hourly maternal blood glucose levels. Intravenous insulin administration commenced at initial corticosteroid dose and continued until maternal blood glucose levels normalised, generally 48-72 hours following last corticosteroid dose.
Control group
Active

Outcomes
Primary outcome [1] 293089 0
Optimisation of glycaemic control (maternal blood glucose targets 4.0-8.0mmol/L)
Timepoint [1] 293089 0
72 hours post-antenatal corticosteroid administration
Secondary outcome [1] 310314 0
Incidence of maternal hypoglycaemia (defined as blood glucose level < 4.0 mmol/L) as assessed by bedside glucometer
Timepoint [1] 310314 0
72 hours post administration of antenatal corticosteroid therapy

Eligibility
Key inclusion criteria
All women with diabetes in pregnancy (including gestational diabetes and pre-existing diabetes) admitted onto the antenatal or delivery ward at Royal Prince Alfred Hospital who receive emergency or elective antenatal corticosteroids for threatened pre-term delivery.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with diabetes in pregnancy who received a dose of antenatal corticosteroids at another institution prior to transfer to Royal Prince Alfred Hospital

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
18/03/2016
Date of last participant enrolment
Anticipated
Actual
3/11/2016
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
50
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2950 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 289898 0
Charities/Societies/Foundations
Name [1] 289898 0
Australasian Diabetes in Pregnancy Society grant (sponsored by NovoNordisk)
Country [1] 289898 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Diabetes Centre
Address
Level 6
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 288585 0
None
Name [1] 288585 0
Address [1] 288585 0
Country [1] 288585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291620 0
SLHD Ethics Review Committee (RPAH Zone) / Animal Welfare Committee
Ethics committee address [1] 291620 0
Level 2
Medical Centre
100 Carillon Ave
Camperdown NSW 2050
Ethics committee country [1] 291620 0
Australia
Date submitted for ethics approval [1] 291620 0
08/09/2014
Approval date [1] 291620 0
13/03/2015
Ethics approval number [1] 291620 0

Summary
Brief summary
Pregnancy may be complicated by threatened pre-term delivery, which is associated with neonatal respiratory distress syndrome. Antenatal corticosteroids reduce the incidence of neonatal respiratory distress syndrome in preterm delivery but cause acute severe maternal hyperglycaemia in pregnancies complicated by diabetes. Data is limited on the blood glucose profile following corticosteroid administration and guidelines to control hyperglycaemia are lacking. Intravenous (IV) insulin infusions may be utilised but are labour intensive and require significant expertise.

This prospective interventional study seeks to prospectively validate in-patient management principles utilising a supplementary subcutaneous (SC) insulin regimen in comparison to IV insulin infusion titrated to predicted maternal hyperglycaemia to reduce hyperglycaemia in diabetic pregnancies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51190 0
Dr Arianne Sweeting
Address 51190 0
Endocrinology & Metabolism Unit
Level 6
Missenden Road
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 51190 0
Australia
Phone 51190 0
+61 2 9515 7226
Fax 51190 0
Email 51190 0
Arianne.Sweeting@sswahs.nsw.gov.au
Contact person for public queries
Name 51191 0
Dr Arianne Sweeting
Address 51191 0
Endocrinology & Metabolism Unit
Level 6
Missenden Road
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 51191 0
Australia
Phone 51191 0
+61 2 9515 7226
Fax 51191 0
Email 51191 0
Arianne.Sweeting@sswahs.nsw.gov.au
Contact person for scientific queries
Name 51192 0
Dr Arianne Sweeting
Address 51192 0
Endocrinology & Metabolism Unit
Level 6
Missenden Road
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 51192 0
Australia
Phone 51192 0
+61 2 9515 7226
Fax 51192 0
Email 51192 0
Arianne.Sweeting@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregated data


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
No additional documents have been identified.