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Trial registered on ANZCTR


Registration number
ACTRN12616001577404
Ethics application status
Approved
Date submitted
12/11/2016
Date registered
15/11/2016
Date last updated
15/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Fetal focus: fetal intramuscular steroids for diabetic women at risk of preterm birth
Scientific title
Effect of fetal intramuscular steroids on maternal hyperglycaemia or ketoacidosis in diabetic women at risk of preterm birth
Secondary ID [1] 290530 0
None
Universal Trial Number (UTN)
U1111-1189-8132
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 300950 0
Diabetes in pregnancy 300951 0
Condition category
Condition code
Reproductive Health and Childbirth 300747 300747 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 300763 300763 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of betamethasone (as Celestone Chronodose (R)) 0.2mg/kg ultrasound-estimated fetal weight, administered by a maternal fetal medicine specialist by ultrasound-guided injection into the fetal thigh between 34w0d and 36w4d gestation
Intervention code [1] 296379 0
Prevention
Comparator / control treatment
2 doses, 24 hours apart, of betamethasone (as Celestone Chronodose (R)) 11.4mg, administered as intramuscular injections to the mother with the first dose given between 34w0d and 36w4d gestation
Control group
Active

Outcomes
Primary outcome [1] 300164 0
Composite of either:
(a) maternal hyperglycaemia, defined as fasting glucose > 5.0 mmol/L or 2h postprandial glucose > 6.6 mmol/L requiring an increase in insulin dose, or
(b) maternal ketoacidosis, defined as positive capillary ketone test or arterial pH < 7.3
Timepoint [1] 300164 0
Within 48 hours of first dose
Secondary outcome [1] 329222 0
Neonatal respiratory morbidity, defined as requirement of at least 2 hours of supplemental oxygen therapy, continuous positive airway pressure, mechanical ventilator support, or surfactant therapy
Timepoint [1] 329222 0
Hospital discharge
Secondary outcome [2] 329223 0
Cord blood insulin
Timepoint [2] 329223 0
Birth
Secondary outcome [3] 329224 0
Neonatal hypoglycaemia requiring treatment by supplemental feeding or intravenous therapy
Timepoint [3] 329224 0
Hospital discharge
Secondary outcome [4] 329225 0
Neonatal sepsis, defined as raised c-reactive protein and requirement for antibiotic therapy
Timepoint [4] 329225 0
Hospital discharge
Secondary outcome [5] 329226 0
Maternal infectious morbidity, defined as requirement for antibiotic treatment
Timepoint [5] 329226 0
6 weeks

Eligibility
Key inclusion criteria
Pregnant woman
Pregestational type 1 or type 2 diabetes mellitus
Delivery indicated between 34w0d and 36w6d gestation
Treating clinician feels that antenatal corticosteroid therapy is indicated
Fetus accessible for intramuscular injection
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years
Unable to provide informed consent
Known fetal anomaly
Multiple 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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
This pilot study will recruit 20 participants. This will afford adequate statistical power to assess the primary outcome, and will also inform the feasibility of recruiting and carrying out a larger, study with adequate power to detect clinically meaningful differences in the secondary outcomes.
Assuming alpha of 0.05 and beta of 0.1, detecting a reduction in maternal hyperglycaemia requiring an increase in insulin dose from 90% in the maternal administration group to 30% in the fetal administration group, would require a total sample size of 18 participants.
Statistical analysis will be by intention to treat and, if appropriate, by treatment received. Maternal and fetal/neonatal characteristics will be assessed with descriptive statistics and compared with appropriate parametric or non-parametric tests for normal and skewed distributions, respectively. The proportional rates of the primary and secondary outcomes will be compared with Chi-squared tests. Continuous outcomes will be assessed with t-tests. A p-value of <0.05 will be considered significant. For outcomes with multiple comparisons, the Bonferroni correction will be applied to account for multiple testing. In this pilot study there will be no planned interim analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2016
Actual
Date of last participant enrolment
Anticipated
15/06/2017
Actual
Date of last data collection
Anticipated
30/08/2017
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6927 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 14604 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 294952 0
Charities/Societies/Foundations
Name [1] 294952 0
Women and Infants Research Foundation
Country [1] 294952 0
Australia
Primary sponsor type
Government body
Name
Women and Newborns Health Service
Address
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 293777 0
University
Name [1] 293777 0
The University of Western Australia
Address [1] 293777 0
School of Women's and Infants' Health
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008
Country [1] 293777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296319 0
Women and Newborns Health Service Human Research Ethics Committee
Ethics committee address [1] 296319 0
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008
Ethics committee country [1] 296319 0
Australia
Date submitted for ethics approval [1] 296319 0
24/08/2016
Approval date [1] 296319 0
08/11/2016
Ethics approval number [1] 296319 0
2016105EW

Summary
Brief summary
Background: Administration of corticosteroids prior to birth is of clear benefit to the preterm neonate, with reductions in respiratory, neurological, gastrointestinal, and infectious morbidity, as well as decreased mortality. This benefit was previously proven to exist up to 34 weeks’ gestation but has recently been demonstrated to apply to all neonates born prior to 37 weeks. This benefit is not achieved without potential complications, however, including hyperglycaemia and ketoacidosis in diabetic mothers and neonatal hypoglycaemia. Direct fetal administration of corticosteroids, by ultrasound-guided intramuscular injection may provide the neonatal benefits of steroids while avoiding the maternal and neonatal complications.
Objectives: This pilot study aims to assess the feasibility of a larger randomised controlled trial of direct fetal administration versus maternal administration of corticosteroids with the following objectives:
a. To assess the effects of directly administered fetal corticosteroids upon maternal glucose homeostasis (hyperglycaemia and ketoacidosis).
b. To demonstrate that direct administration of fetal corticosteroids is not associated with adverse fetal/neonatal outcomes including excess preterm birth or neurovascular injuries
Trial plan: This pilot randomised controlled trial will recruit 20 pregnant women with pregestational type 1 or type 2 diabetes who are planned for delivery between 34+0 and 36+6 weeks’ gestation and therefore candidates for antenatal corticosteroid administration. Consenting women will be randomised to receive either standard maternal administration of two doses of betamethasone or direct fetal intramuscular injection of a single dose of betamethasone. The primary outcome will be the rate of hyperglycaemia or ketoacidodis requiring treatment. Secondary outcomes will include neonatal rates of respiratory morbidity, hypoglycaemia, and sepsis, and maternal infectious morbidity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70426 0
Dr Scott White
Address 70426 0
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008
Country 70426 0
Australia
Phone 70426 0
+61864582222
Fax 70426 0
+61864581060
Email 70426 0
[email protected]
Contact person for public queries
Name 70427 0
Scott White
Address 70427 0
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008
Country 70427 0
Australia
Phone 70427 0
+61864582222
Fax 70427 0
+61864581060
Email 70427 0
[email protected]
Contact person for scientific queries
Name 70428 0
Scott White
Address 70428 0
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008
Country 70428 0
Australia
Phone 70428 0
+61864582222
Fax 70428 0
+61864501060
Email 70428 0
[email protected]

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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