Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women

Study Overview
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Brief Summary
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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.

Detailed Description
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About 2 to 9% of pregnant women are diagnosed with gestational diabetes. Peripartum complications attributed to diabetes include: birth trauma, neonatal hypoglycemia and hyperinsulinemia and neonatal hyperbilirubinemia. The incidence of neonatal hypoglycemia is about 40%. Strict glycemic control may lower the risk of neonatal complications. There is a lack of evidence on how to manage women with diabetes during labor. Previous studies recommended the use of intravenous saline solution boosted with 5% glucose and insulin as needed, glucose 5% with constant insulin infusion and others recommended the use lactated Ringer's solution. Most of these studies are either retrospective or have a small number of participants. In this study we will examine the effect of 2 different protocols on glycemic control during labor and the immediate neonatal period. Women in group 1, will receive intravenous saline solution boosted with 5% glucose and constant insulin infusion. Women in group 2, will receive intravenous saline solution boosted with 5% glucose alone. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Women in both groups will receive additional insulin infusion in cases of glucose levels above 100 mg/dL. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution in cases of glucose levels above 140 mg/dL. Intravenous fluid regimens will be assigned according to a computer randomization sequence generation program. Women will randomly assigned to the 2 groups in a 1:1 ratio. The randomization sequence results will be kept in the delivery ward in a closed study box. Site investigators will enroll participants after confirming eligibility. The sequence will be concealed until intervention is assigned (and after obtaining a signed informed consent). Our hypothesis is that 5% glucose combined with constant insulin infusion will achieve better glycemic control and thus will lead to lower rate of neonatal hypoglycemia. In order to detect a reduction of neonatal hypoglycemia from 40% to 20%, 182 women will be needed in both groups in order to achieve a level of significance of 95% (α, 2-sided = 0.05) and a power of 80% (β = 0.2).

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

Conditions
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Obstetric Labor, Pregnancy in Diabetics

Intervention / Treatment
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* Drug: glucose solution and Insulin
* Drug: glucose solution only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glucose solution and insulin<br>Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h. | Drug: glucose solution and Insulin<br>* 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.<br>* Other names: Group 1;Drug: glucose solution only<br>* 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.<br>* Other names: Group 2;|
| Active Comparator: glucose solution only<br>Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h. | Drug: glucose solution and Insulin<br>* 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.<br>* Other names: Group 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal hypoglycemia | about 2-3 hours postpartum the neonate will have a capillary glucose test | 2-3 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal glycemic control during labor | During labor glucose level will be obtained every hour. Average glucose level during labor will be calculated after labor. | 24 hours | 
| Maternal urine ketones | Immediately post partum maternal urine will be checked for ketones | 1 hour | 
| Total amount of regular insulin during labor | The total amount of regular insulin during labor will be calculated post partum | 24 hours | 
| Mode of delivery | Mode of delivery | 1 hour | 
| Length of delivery | Length of delivery | 24 hours | 
| Breastfeeding | How many women breastfed in every study group | 48 hours | 
| Neonatal APGAR score | Neonatal APGAR score | 5 minutes | 
| Umbilical cord PH | Umbilical cord PH | 30 minutes | 
| Umbilical cord glucose level | Umbilical cord glucose level | 30 minutes | 
| The need for neonatal IV glucose infusion | The need for neonatal IV glucose infusion | 48 hours | 
| Neonatal jaundice | Neonatal jaundice- hyperbilirubinemia | 48 hours | 
| Length of neonatal hospital stay | Length of neonatal hospital stay | 30 days | 
| NICU admission | NICU admission | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes mellitus, Pre-gestational diabetes mellitus, Treatment, Neonatal hypoglycemia