Comparison of glibenclamide and insulin on neonatal outcomes in pregnant women with gestational diabetes

Abstract

Background:Untreated or poorly controlled gestational diabetes can cause serious complications for mother and newborn. Glibenclamide is rarely used in treating mothers with this disease. This study aimed at comparing the effect of glibenclamide and insulin on neonatal outcomes in women with gestational diabetes mellitus.Methods:In this randomized controlled clinical trial, 249 pregnant women aged 18–45 years within the 11th–33rd weeks of gestation with gestational diabetes, single fetus pregnancy, and in need of hyperglycemia treatment were entered and grouped randomly as either glibenclamide or insulin. In the insulin group (n = 129), insulin was administered with an initial dose of 0.2 IU/kg subcutaneously twice per day, whereas in the glibenclamide group (n = 120), 1.25 mg oral glibenclamide was administered once daily and increased if needed.Results:The results showed no significant difference in means age, gestational age, and body mass index between women in the two groups. In addition, there were no significant differences in the frequency of neonatal hypoglycemia, anomaly, hyperbilirubinemia, admission in Neonatal Intensive Care Unit (NICU), and neonatal respiratory distress between two groups. Macrosomia was lower in the glibenclamide group than the insulin group (3.3% vs. 13.2%, respectively, P = 0.005). Regression logistics model results showed that the type of treatment (odds ratio [OR]: 4.62; confidence interval [CI]: 1.45–14.02; P = 0.01) and gestational age at delivery (OR: 1.41; CI: 1.04–1.74; P = 0.01) were as predictor factors of macrosomia.Conclusions:The results of this study revealed that glibenclamide is able to reduce the risk of fetal macrosomia without increasing neonatal anomalies, jaundice, hypocalcemia, infant respiratory distress, and NICU admission.

Comparison of glyburide and insulin in the management of gestational diabetes: A meta-analysis

“…Fig 1 shows the process of the literature search and selection. A final set of ten randomized control trials with a total of 1194 participants meeting the inclusion criteria were included in this meta-analysis (575 on glyburide; 619 on insulin) [ 19 , 24 , 28 , 29 , 32 – 37 ]. Countries included in these studies were USA, Brazil, India and Iran.…”

“…Countries included in these studies were USA, Brazil, India and Iran. The two larger studies involved more than 100 subjects each [ 19 , 32 ], while the other eight trials involved fewer than 100 participants each. Characteristics and baseline data are shown in Tables 1 – 3 , respectively.…”

“…Fig 2 illustrates the risk of bias of the included studies comparing glyburide and insulin, with the summary shown in Fig 3 . The studies by Mirzamoradi [ 29 ] and Behrashi [ 32 ] are the new RCTs included in our meta-analysis. Six of the studies provided specific sequence generation methods [ 19 , 28 , 29 , 32 , 36 , 37 ], while the remaining four studies did not offer information on this domain [ 24 , 33 – 35 ].…”

“…The studies by Mirzamoradi [ 29 ] and Behrashi [ 32 ] are the new RCTs included in our meta-analysis. Six of the studies provided specific sequence generation methods [ 19 , 28 , 29 , 32 , 36 , 37 ], while the remaining four studies did not offer information on this domain [ 24 , 33 – 35 ]. Allocation concealment was provided in five studies [ 19 , 29 , 33 , 36 , 37 ], whereas this information was unclear in the other five studies [ 24 , 28 , 32 , 34 , 35 ].…”

“…Data regarding its use in GDM are conflicting [ 18 , 24 , 26 – 31 ]. Two new randomized control trials comparing treatment with glyburide and insulin in GDM have recently been published [ 29 , 32 ]. A meta-analysis of the updated data, including previously available data and the recently published trials, might provide stronger evidence with respect to the effectiveness and safety of glyburide.…”