Clinical trial NCT02590016: Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
Official title: 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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gestational Diabetes
Hypoglycemia, Neonatal
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Intrapartum blood glucose level has negative correlation to neonatal blood glucose level in type 1 diabetics. In gestational diabetes the correlation is less clear. In the view of current knowledge, it seems that moderately elevated intrapartum blood glucose may not cause neonatal hypoglycemia. There is no consensus of how to treat intrapartum blood glucose level in gestational diabetics. Some studies have implied that most of mothers with gestational diabetes would have normal blood glucose level during labour and hence would not need any intervention if their daily insulin dosage is less than 0,5-1 IU/kg.

Study participants are recruited into the study at Tampere University Hospital Maternity Ward when their daily insulin dose exceeds 30 IU. Randomization is done at 37th gestational week, if vaginal delivery is planned, and HbA1c is measured. Randomization envelope is opened at the delivery ward when active labour begins and treatment of blood glucose level is carried out accordingly. If insulin dose is 1 IU/kg or more, the participant is treated as in active treatment group despite of result of randomization. All neonates will receive milk substitute after birth in labour ward. Plasma glucose is measured immediately if neonate has symptoms of low blood sugar. If not, plasma glucose is measured approximately two hours after birth and after that every 4 hours until plasma glucose is 3,0 mmol/l or more in three consecutive measurements.

Eligibility criteria: Inclusion Criteria:

* pregnant women with gestational diabetes mellitus and daily insulin dosage of 30 IU or more

Exclusion Criteria:

* planned caesarean section,
* premature birth (\< 37 gestational weeks)

Primary outcomes:
measure: Neonatal hypoglycemia
timeFrame: within 48 hours after birth
Secondary outcomes:
measure: Moderate neonatal hypoglycemia
timeFrame: within 48 hours after birth
measure: Severe neonatal hypoglycemia
timeFrame: within 48 hours after birth
measure: Duration of neonatal blood glucose monitoring
timeFrame: within a week after birth
measure: Proportion of participants needing insulin-glucose-infusion in the observational arm
timeFrame: during active labour
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Obstetrics and Gynecology Unit: Tampere University Hospital
Study officials:
affiliation: Obstetrics and Gynecology Unit: Tampere University Hospital
name: Elina Kivekäs, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Stenninger E, Schollin J, Aman J. Early postnatal hypoglycaemia in newborn infants of diabetic mothers. Acta Paediatr. 1997 Dec;86(12):1374-6. doi: 10.1111/j.1651-2227.1997.tb14916.x.
citation: Ryan EA, Al-Agha R. Glucose control during labor and delivery. Curr Diab Rep. 2014 Jan;14(1):450. doi: 10.1007/s11892-013-0450-4.
citation: Ryan EA, Sia WW, Khurana R, Marnoch CA, Nerenberg KA, Ghosh M. Glucose control during labour in diabetic women. J Obstet Gynaecol Can. 2012 Dec;34(12):1149-1157. doi: 10.1016/S1701-2163(16)35462-7.