Optimisation of Glycaemic Control in the Setting of Antenatal Corticosteroid Administration in Pregnancies Complicated by Diabetes

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001083684
• Date of registration: 09/10/2014
• Prospective Registration: Yes
• Primary sponsor: Royal Prince Alfred Hospital Diabetes Centre
• 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
• Date of first enrolment: 18/03/2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001083684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Arianne Sweeting

• Name: Dr Arianne Sweeting

Key inclusion & exclusion criteria

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.



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

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Diabetes in pregnancy;
Diabetes in pregnancy

Metabolic and Endocrine - Diabetes

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Intervention(s)

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.

Primary Outcome(s)

Optimisation of glycaemic control (maternal blood glucose targets 4.0-8.0mmol/L)[72 hours post-antenatal corticosteroid administration]

Secondary Outcome(s)

Incidence of maternal hypoglycaemia (defined as blood glucose level < 4.0 mmol/L) as assessed by bedside glucometer[72 hours post administration of antenatal corticosteroid therapy]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Australasian Diabetes in Pregnancy Society grant (sponsored by NovoNordisk)

Ethics review

Status: Approved
Approval date:
Contact:

SLHD Ethics Review Committee (RPAH Zone) / Animal Welfare Committee

Results

• Results available: Yes
• Date Posted: 30/07/2019
• Date Completed: 01/01/2017