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临床试验/NCT02590016
NCT02590016Unknown4 期

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?

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Insulin-glucose-infusion is administered once active labour begins and will be continued until birth.

干预措施: Insulin, Aspart (Drug)

Observation

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elina Kivekäs

MD

Tampere University Hospital

研究点 (1)

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