Comparison of Outcomes Among Neonates Born to Diabetic Mothers Receiving Insulin and Metformin: A Prospective Observational Study

Abstract

Background: Indian national guidelines (2018) adopted treatment with metformin as first choice of pharmacological agent next to medical nutritional therapy during pregnancy for diabetic mothers after 20 weeks of gestation. Objectives: A prospective observational study was planned to compare outcome of neonates of diabetic mothers categorized across different treatment regimens (I: meal plan only, II: meal plan and metformin or III: meal plan and insulin). Materials and methods: 100 neonates born to mothers with diabetes mellitus (DM) were included; early neonatal outcomes such as hypoglycemia, hypocalcemia, neonatal hyperbilirubinemia (NNH), birth asphyxia, polycythemia, respiratory distress (RD), birth injuries, congenital anomalies, large for gestational age (LGA) and admission to neonatal intensive care unit (NICU) were compared across the different categories of treatment in mothers. Results: Among the 100 included neonates, 37 were born to mothers who received only meal plan; 44 to mothers who received meal plan and metformin; 19 to mothers with meal plan and insulin. There was statistically significant (Fisher’s exact test) increase in incidence of congenital anomalies (P value= 0.0000); hypoglycemia (P value= 0.023), hypocalcemia (P value= 0.00004), NNH (P value= 0.0001), RD (P value= 0.013), LGA (P value= 0.0027) and NICU admissions (P value= 0.005) in meal plan and insulin group (Group III). Binary logistic regression analysis revealed that neonates of mothers treated with meal plan and insulin had 11 times increased odds of experiencing NNH. Conclusion: There was no difference in outcomes of neonates born to mothers receiving different treatments for DM (meal plan only/ meal plan and metformin/ meal plan and insulin) except NNH.