44: Randomized controlled trial of intrapartum glucose management in women with gestational diabetes: NCT02596932

Abstract

To assess the effect of tight compared to liberalized intrapartum maternal blood glucose management for women with gestational diabetes mellitus (GDM) on neonatal blood glucose concentrations. Randomized controlled trial of women with singleton gestations and GDM attempting vaginal delivery. After written informed consent, women were randomly allocated to one of two intrapartum maternal glucose management protocols: tight control (hourly blood glucose measurements and treatment for maternal blood glucose <60 mg/dL or >100 mg/dL) or liberalized control (blood glucose measurements every four hours and treatment for maternal blood glucose <60 mg/dL or >120 mg/dL). The pediatric team assessing and treating the neonates were blinded to study group. The primary study outcome was the first neonatal blood glucose concentration (assessed within 2 hours of birth); the study was powered to have 80% power to detect a mean difference of 10 mg/dL between groups. Secondary outcomes included neonatal blood glucose concentrations within the first 24 hours of life, number of glucose treatments (IV or PO) that neonates received to improve their glucose, NICU admission, and neonatal hyperbilirubinemia. From February 2016 to April 2018, 76 women were enrolled and all were included in the analysis: 38 in the tight control group and 38 in the liberalized group. Baseline characteristics of the two groups were comparable for all relevant obstetric variables; mean gestational age was 39 weeks in both groups. Antepartum, two thirds of women in each group were managed medically (almost exclusively with insulin). The primary outcome was similar between tight and liberalized groups: 53 mg/dL compared to 58 mg/dL, P=0.6. However, within the first 24 hours of life, mean neonatal glucose concentrations were lower in the tight control group: 54 mg/dL compared to 58 mg/dL, P=0.049. Other secondary outcomes were similar between groups. A protocol aimed at tight maternal glucose management in labor, compared to liberalized management for women with GDM did not result in better initial neonatal glucose values and was associated with lower mean neonatal blood glucose concentrations in the first 24 hours of life. This study supports raising the upper threshold for intrapartum maternal glucose concentration and decreasing the frequency of intrapartum glucose assessment for women with GDM.