NCT03912363

Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: Female
• Age: 14 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Type II Diabetes Mellitus
• Gestational Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Rotating fluids protocol	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)
OTHER	Insulin infusion protocol	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

Timeline

• Start date: 2019-11-01
• Primary completion: 2024-05-30
• Completion: 2025-03-01
• First posted: 2019-04-11
• Last updated: 2025-06-12

Locations

2 sites across 1 country: United States