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Clinical trial

Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial

ID
Name
0056-17-EMC
Description
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.
Trial arms
Trial start
2017-10-31
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Treatment
glucose solution and Insulin
Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour. Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution. Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour. Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour.
Arms:
glucose solution and insulin, glucose solution only
Other names:
Group 1
glucose solution only
Women in group 2, will receive intravenous saline solution boosted with 5% glucose only, at a rate of 125mL/h. Women in this group will be treated similar to group 1 if glucose levels crossed over 100 mg/dL.
Arms:
glucose solution and insulin
Other names:
Group 2
Size
200
Primary endpoint
Neonatal hypoglycemia
2-3 hours postpartum
Eligibility criteria
Inclusion Criteria: * \>37 weeks gestation * gestational diabetes mellitus according to Carpenter and Coustan * pregestational diabetes mellitus Exclusion Criteria: * Intrauterine fetal death * estimated fetal weight\<10p * multiple gestation * major fetal malformations
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-10-11

1 organization

Organization
HaEmek Medical Center