ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1189-8132

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preterm birth

Diabetes in pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Metabolic and Endocrine

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]

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]

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]

Within 48 hours of first dose

Secondary outcome [1]

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]

Hospital discharge

Secondary outcome [2]

Cord blood insulin

Timepoint [2]

Birth

Secondary outcome [3]

Neonatal hypoglycaemia requiring treatment by supplemental feeding or intravenous therapy

Timepoint [3]

Hospital discharge

Secondary outcome [4]

Neonatal sepsis, defined as raised c-reactive protein and requirement for antibiotic therapy

Timepoint [4]

Hospital discharge

Secondary outcome [5]

Maternal infectious morbidity, defined as requirement for antibiotic treatment

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Women and Infants Research Foundation

Address [1]

Carson House
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008

Country [1]

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]

University

Name [1]

The University of Western Australia

Address [1]

School of Women's and Infants' Health
King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women and Newborns Health Service Human Research Ethics Committee

Ethics committee address [1]

King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/08/2016

Approval date [1]

08/11/2016

Ethics approval number [1]

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

Dr Scott White

Address

King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008

Country

Australia

Phone

+61864582222

Fax

+61864581060

Scott.White@health.wa.gov.au

Contact person for public queries

Name

Scott White

Address

King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008

Country

Australia

Phone

+61864582222

Fax

+61864581060

Scott.White@health.wa.gov.au

Contact person for scientific queries

Name

Scott White

Address

King Edward Memorial Hospital
374 Bagot Road
SUBIACO WA 6008

Country

Australia

Phone

+61864582222

Fax

+61864501060

Scott.White@health.wa.gov.au

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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Documents added automatically

No additional documents have been identified.

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