Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: Insulin-Glucose-Infusion Versus Observational Approach - Is There a Difference in Neonatal Hypoglycemia Rate?

NCT02590016 Phase 4 UNKNOWN

Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour. In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia between the two groups and that the proportion of observational group participants that need infusion is low.

Details

Lead sponsor	Tampere University Hospital
Phase	Phase 4
Status	UNKNOWN
Enrolment	50
Start date	2015-09
Completion	2021-11

Conditions

• Gestational Diabetes
• Hypoglycemia, Neonatal

Interventions

• Insulin, Aspart

Primary outcomes

• Neonatal hypoglycemia — within 48 hours after birth
  Neonatal plasma blood glucose \< 3 mmol/l

Countries

Finland