OBJECTIVES: To study glibenclamide as a treatment for gestational diabetes mellitus (GDM) and its impact on newborn birth weight and neonatal glycemia as compared to insulin. METHODS: A randomized and open-label clinical trial, conducted from October 1st, 2003 to March 8, 2005. Seventy-two pregnant women with gestational diabetes mellitus requiring drug therapy were randomized and allocated into two groups--insulin and glibenclamide. RESULTS: The general characteristics in both groups were similar, except for the results of the 75 g OGTT, which were higher in the glibenclamide group (p= 0.02). Maternal fasting and postprandial glucose levels presented no difference. Six (18.75%) pregnant women received the maximum dose of glibenclamide with no glycemic control. The birth weight was higher in the group treated with glibenclamide (p= 0.01), and the incidence of macrosomic newborns statistically different (p= 0.01). Neonatal hypoglycemia was more frequent (p= 0.01) in newborns of glibenclamide group, with one single case of persistent hypoglycemia. CONCLUSION:Glibenclamide can be the first line drug for glycemic control in most GDM patients. The birth weight and incidence of hypoglycemia were higher in the glibenclamide group, but with one single case of persistent hypoglycemia that required intravenous infusion of glucose.
RCT Entities:
OBJECTIVES: To study glibenclamide as a treatment for gestational diabetes mellitus (GDM) and its impact on newborn birth weight and neonatal glycemia as compared to insulin. METHODS: A randomized and open-label clinical trial, conducted from October 1st, 2003 to March 8, 2005. Seventy-two pregnant women with gestational diabetes mellitus requiring drug therapy were randomized and allocated into two groups--insulin and glibenclamide. RESULTS: The general characteristics in both groups were similar, except for the results of the 75 g OGTT, which were higher in the glibenclamide group (p= 0.02). Maternal fasting and postprandial glucose levels presented no difference. Six (18.75%) pregnant women received the maximum dose of glibenclamide with no glycemic control. The birth weight was higher in the group treated with glibenclamide (p= 0.01), and the incidence of macrosomic newborns statistically different (p= 0.01). Neonatal hypoglycemia was more frequent (p= 0.01) in newborns of glibenclamide group, with one single case of persistent hypoglycemia. CONCLUSION:Glibenclamide can be the first line drug for glycemic control in most GDM patients. The birth weight and incidence of hypoglycemia were higher in the glibenclamide group, but with one single case of persistent hypoglycemia that required intravenous infusion of glucose.
Authors: Marianna Faraci; Fosca A F Di Prima; Oriana Valenti; Entela Hyseni; Santo Monte; Elsa Giorgio; Roberta De Domenico Journal: J Prenat Med Date: 2011-07
Authors: Diane Farrar; Mark Simmonds; Maria Bryant; Trevor A Sheldon; Derek Tuffnell; Su Golder; Debbie A Lawlor Journal: BMJ Open Date: 2017-06-24 Impact factor: 2.692