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?
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Neonatal hypoglycemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with gestational diabetes mellitus and daily insulin dosage of 30 IU or more
排除标准
- •planned caesarean section,
- •premature birth (< 37 gestational weeks)
研究组 & 干预措施
Insulin-glucose-infusion
Insulin-glucose-infusion is administered once active labour begins and will be continued until birth.
干预措施: Insulin, Aspart (Drug)
Observation
Plasma glucose level is measured every 1-2 hours during active labour and insulin-glucose-infusion is started if plasma glucose level exceeds 7,5 mmol/l in two subsequent measurements.
干预措施: Insulin, Aspart (Drug)
结局指标
主要结局
Neonatal hypoglycemia
时间窗: within 48 hours after birth
Neonatal plasma blood glucose \< 3 mmol/l
次要结局
- Proportion of participants needing insulin-glucose-infusion in the observational arm(during active labour)
- Moderate neonatal hypoglycemia(within 48 hours after birth)
- Severe neonatal hypoglycemia(within 48 hours after birth)
- Duration of neonatal blood glucose monitoring(within a week after birth)
研究者
Elina Kivekäs
MD
Tampere University Hospital
