Intrapartum Glycemic Control with Insulin Infusion versus Rotating Fluids: A Randomized Controlled Trial.

Abstract

Objective:  This study aimed to evaluate rotating intravenous (IV) fluids compared with insulin infusion for maternal intrapartum glycemic control of neonatal blood glucose within 2 hours of birth.

Study design:  This randomized controlled trial compared the use of rotating IV fluids to continuous insulin infusion for intrapartum glycemic control for patients with type II diabetes mellitus (DM) or medication-controlled gestational diabetes (A2GDM). A sample size of 74 participants was studied to detect a 10-mg/dL difference in neonatal blood glucose within 2 hours of birth between the groups with a standard deviation of 15, 80% power, and α 0.05. Secondary neonatal outcomes included neonatal blood glucose within 24 hours after birth, Apgar < 7 at 5 minutes, and a composite including neonatal hypoglycemia, NICU admission, hyperbilirubinemia, and respiratory distress syndrome. Secondary maternal outcomes included intrapartum hypoglycemia, blood glucose immediately prior to delivery, mode of delivery, and postpartum complications. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed.

Results:  A total of 114 patients were randomized, 57 in each arm. For the PP analysis, 51 patients were analyzed in the rotating IV fluids arm and 32 patients in the insulin infusion arm. There was no significant difference in neonatal blood glucose within 2 hours of birth when rotating IV fluids were used (ITT: 54.5 mg/dL [IQR: 42.5, 72.5], PP: 56.0 mg/dL [IQR: 42.0, 76.0]) when compared with an insulin infusion (ITT: 59.0 mg/dL [IQR: 41.0, 69.0], PP: 62.5 mg/dL [IQR: 44.5, 68.5], p = 0.89 [ITT] and p = 0.68 [PP]). No significant differences were noted in secondary outcomes. The median intrapartum maternal blood glucose was 98.5 mg/dL (IQR: 90.5, 105.0) in the rotating fluids arm and 96.3 mg/dL (IQR: 90.0, 108.5) in the insulin infusion arm (p = 0.96), and the rate of neonatal hypoglycemia was 11.8 versus 15.6%, respectively (p = 0.61) in the PP analysis.

Conclusion:  There was no difference in neonatal blood glucose within 2 hours of birth when rotating IV fluids were used for intrapartum glycemic control compared with a continuous insulin infusion.

Key points: · There is no optimal option for maternal glycemic control in labor.. · Maternal glycemic control was comparable in the two study arms.. · There was no difference in neonatal blood glucose between study arms..