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

Subcutaneous versus Intravenous Insulin Therapy for Glycaemic Control in the Setting of Antenatal Corticosteroid Administration in Pregnancies Complicated by Diabetes

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001083684

Enrollment

Registered

2014-10-09

Start date

2016-03-18

Completion date

2016-11-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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

Outcome results