Nayereh Ghomian1, Seyede Houra Mousavi Vahed1, Samaneh Firouz1, Mohammad Ali Yaghoubi2, Masoud Mohebbi3, Amirhossein Sahebkar4,5,6. 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 2. Birjand University of Medical Sciences, Birjand, Iran. 3. Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 4. Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran. 5. Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 6. School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Abstract
BACKGROUND:Insulin has been a conventional medication in the treatment of female patients suffering from gestational diabetes mellitus (GDM). However, the need for a large number of insulin injections in these patients causes them a lot of discomforts. Recently, an alternative medication, metformin, has received considerable attention in the treatment of GDM. The aim of this study was to compare the efficacy of metformin and insulin in regulating blood glucose levels and fetal outcomes in GDM. METHODS: This randomized clinical trial included 286 pregnant women diagnosed with positive GDM at 24-28 weeks of pregnancy. The subjects were randomly divided into two groups of 143 patients, with one group receiving insulin and the other undergoing a treatment plan using metformin. Fasting plasma glucose (FPG), 2-hr plasma glucose (PG) and glycated hemoglobin (HbA1c) were recorded twice a month until delivery. Other variables, including birth delivery method, cause of cesarean section, gestational age at the delivery time, birth trauma, Apgar score, birth weight, admission at neonatal intensive care unit (NICU), and neonatal hypoglycemia were also registered. RESULTS: Age of mother, body mass index, history of diabetes in the family, previous history of GDM, parity, FPG, 1- and 2-hr PG after meals, and 75-g glucose tolerance test before treatment were not statistically different between the two groups. FPG, PG, and HbA1c did not show significant differences between the two groups after completing the course of treatment. There was also no significant difference between two groups regarding the birth delivery method, the cause of cesarean section, birth trauma, Apgar score, birth weight, admission at NICU, and neonatal hypoglycemia. CONCLUSION: As mean FPG and 2-hr PG were not significantly different between the two groups, it seems that metformin can be recommended as an effective substitute for insulin in the treatment of GDM. However, there are still some undesirable risk factors with both treatments that may threaten the mother and the newborn.
RCT Entities:
BACKGROUND:Insulin has been a conventional medication in the treatment of female patients suffering from gestational diabetes mellitus (GDM). However, the need for a large number of insulin injections in these patients causes them a lot of discomforts. Recently, an alternative medication, metformin, has received considerable attention in the treatment of GDM. The aim of this study was to compare the efficacy of metformin and insulin in regulating blood glucose levels and fetal outcomes in GDM. METHODS: This randomized clinical trial included 286 pregnant women diagnosed with positive GDM at 24-28 weeks of pregnancy. The subjects were randomly divided into two groups of 143 patients, with one group receiving insulin and the other undergoing a treatment plan using metformin. Fasting plasma glucose (FPG), 2-hr plasma glucose (PG) and glycated hemoglobin (HbA1c) were recorded twice a month until delivery. Other variables, including birth delivery method, cause of cesarean section, gestational age at the delivery time, birth trauma, Apgar score, birth weight, admission at neonatal intensive care unit (NICU), and neonatal hypoglycemia were also registered. RESULTS: Age of mother, body mass index, history of diabetes in the family, previous history of GDM, parity, FPG, 1- and 2-hr PG after meals, and 75-g glucose tolerance test before treatment were not statistically different between the two groups. FPG, PG, and HbA1c did not show significant differences between the two groups after completing the course of treatment. There was also no significant difference between two groups regarding the birth delivery method, the cause of cesarean section, birth trauma, Apgar score, birth weight, admission at NICU, and neonatal hypoglycemia. CONCLUSION: As mean FPG and 2-hr PG were not significantly different between the two groups, it seems that metformin can be recommended as an effective substitute for insulin in the treatment of GDM. However, there are still some undesirable risk factors with both treatments that may threaten the mother and the newborn.