Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there is a paucity of data guiding practitioners in the intrapartum management of blood glucose levels for women with GDM, particularly those treated with insulin antepartum. The goal of this project is to compare two protocols of intrapartum glucose management in women with GDM and investigate the impact on neonatal blood glucose levels.

Detailed Description
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Research objective- To compare Tight vs. Less Tight intrapartum glucose management Hypothesis: Neonates born to mothers managed via the Less Tight intrapartum glucose management protocol will have lower mean glucose levels in the first 24 hours of life when compared to mean glucose levels among infants born to mothers managed via the Tight intrapartum glucose management protocol. Study Design: Randomized trial Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital Once enrolled, patients will then be randomized to Tight or Less Tight intrapartum glucose control. Once admitted to the labor floor for intrapartum management the appropriate power plan for glucose control will be initiated. The specifics of labor management will be left to the discretion of the provider.

Official Title
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Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: Standard Protocol for intrapartum glucose management
* Other: Experimental Protocol for intrapartum glucose management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital Exclusion Criteria: Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require NICU admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tight control<br>Intervention Standard Care: Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60 mg/dL | Other: Standard Protocol for intrapartum glucose management<br>* Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60mg/dL<br>* Other names: Tight Control;|
| Experimental: Less tight control<br>Intervention: Less Tight glucose control protocol: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60mg/dL | Other: Experimental Protocol for intrapartum glucose management<br>* Less Tight: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60 mg/dL<br>* Other names: Less Tight Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean neonatal blood glucose levels |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Intensive Care Unit (NICU) admission | Any admission to Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home | Birth of neonate until time of discharge of neonate to home up to 7 days | 
| Hours in Neonatal Intensive Care Unit (NICU) | Any time spent in Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home | Birth of neonate until time of discharge of neonate to home up to 7 days | 
| Maternal hypoglycemia |  | Intrapartum period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrapartum