Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

Study Overview
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Brief Summary
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This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.

Detailed Description
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Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%). Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia. Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L&D) unit. The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.

Official Title
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Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)

Conditions
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Type II Diabetes Mellitus, Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: Rotating fluids protocol
* Other: Insulin infusion protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2) Singleton pregnancies Gestational age between 37 0/7 weeks and 40 0/7 weeks Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV) English or Spanish speaking Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization) Exclusion Criteria: Women with Type 1 diabetes mellitus or use of insulin pump Evidence of diabetic ketoacidosis at time of admission for delivery Multifetal gestation Gestational age < 37 0/7 weeks or > 40 0/7 weeks Non-English or Non-Spanish speaking Anticipated delivery < 4 hours from randomization (e.g., cervical dilation > 7 cm at time of randomization, first cesarean delivery of the day) Oral corticosteroid use within 48 hours of planned delivery Antenatal corticosteroid use within 7 days of admission for delivery Delivery planned outside of GMC or GWV Fetal demise Prenatal diagnosis of lethal fetal anomaly Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 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
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotating fluids<br>Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery. | Other: Rotating fluids protocol<br>* IV fluids at a rate of 100-150 ml/hr will be administered: For blood glucose < 100 mg/dL or less: IV fluids with 5% dextrose For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose For blood glucose > 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2)<br>|
| Active Comparator: Insulin infusion<br>Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery. | Other: Insulin infusion protocol<br>* Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered: For blood glucose < 80 mg/dL: No insulin AND IV fluids with 5% dextrose For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose For blood glucose > 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal blood glucose value | Neonatal blood glucose value from birth to 2 hours of life | Within 2 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean neonatal blood glucose value | Average of neonatal blood glucose values from birth to 24 hours of life | First 24 hours of life | 
| Incidence of maternal hypoglycemia | Blood glucose value < 50 mg/dL without symptoms OR Blood glucose value < 70 mg/dL with symptoms such as perspiration, palpitations, tremor, weakness, anxiety | During labor (average time 24 hours) | 
| Mean intrapartum maternal blood glucose value | Average of maternal blood glucose values during labor | During labor (average time 24 hours) | 
| Maternal blood glucose value before delivery | Blood glucose value | Within one hour of delivery | 
| Incidence of composite neonatal outcome | Neonatal hypoglycemia, NICU admission, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome | First 24 hours of life until discharge (average time 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrapartum, glycemic control, diabetes, insulin