human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 aim ed at comparing the effect of glibenclamide and insulin on neonatal outcomes in women with gestational diabetes mellitus . Methods : In this r and omized 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 r and omly 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 Objective . To examine perinatal outcomes in women with gestational diabetes mellitus treated with glyburide  compared to insulin injections . Study design . This is a retrospective cohort study of women diagnosed with gestational diabetes mellitus ( GDM ) who required pharmaceutical therapy and were enrolled in the Sweet Success California Diabetes and Pregnancy Program between 2001 and 2004 , a California state-wide program . Women managed with glyburide were compared to women treated with insulin injections . Perinatal outcomes were compared using chi-square test and multivariable logistic regression models ; statistical significance was indicated by p < 0.05 and 95 % confidence intervals ( CI ) . Results . Among the 10,682 women with GDM who required medical therapy and met study criteria , 2073 ( 19.4 % ) received glyburide and 8609 ( 80.6 % ) received subcutaneous insulin injections . Compared to insulin therapy and controlling for confounders , oral hypoglycemic treatment was associated with increased risk of birthweight > 4000 g ( aOR = 1.29 ; 95 % CI [ 1.03–1.64 ] ) , and admission to the intensive care nursery ( aOR = 1.46 [ 1.07–2.00 ] ) . Conclusion . Neonates born to women with gestational diabetes managed on glyburide , and were more likely to be macrosomic and to be admitted to the intensive care unit compared to those treated with insulin injections . These findings should be examined in a large , prospect i ve trial Context Metformin is used in pregnancy in women with gestational diabetes mellitus , polycystic ovary syndrome ( PCOS ) , and obesity .  Metformin passes the placenta . Objective To explore the effects of metformin use in PCOS pregnancies on offspring growth to 4 years of age . Design Follow-up study of two r and omized , double-blind , placebo-controlled trials . Setting Secondary care centers . Eleven public hospitals in Norway . Participants One hundred eighty-two children of mothers with PCOS who participated in two r and omized controlled trials . Intervention Metformin 1700 or 2000 mg/d or placebo from first trimester to delivery in the original studies . No intervention in the current study . Main Outcome Measures Height , weight , body mass index ( BMI ) , and overweight/obesity at 4 years of age and head circumference at 1 year of age , converted to z scores . Results The difference in height z score means between the groups at 4 years of age was nonsignificant ( 0.07 [ 95 % confidence interval ( CI ) : -0.22 to 0.36 ] ; P = 0.651 ) . At 4 years of age , the metformin group had higher weight z score than the placebo group [ difference in means : 0.38 ( 0.07 to 0.69 ) ; P = 0.017 ] and higher BMI z score [ difference in means : 0.45 ( 0.11 to 0.78 ) ; P = 0.010 ] . There were more overweight/obese children in the metformin group [ 26 ( 32 % ) ] than in the placebo group [ 14 ( 18 % ) ] at 4 years of age [ odds ratio : 2.17 ( 1.04 to 4.61 ) ; P = 0.038 ] . The difference in mean head circumference z score at 1 year of age was 0.27 ( -0.04 to 0.58 ; P = 0.093 ) . Conclusion Metformin-exposed  children had higher BMI and increased prevalence of overweight/obesity at 4 years of age The  pregnancy  outcome of 33 women with gestational diabetes who were treated with glibenclamide and changed to insulin if glibenclamide failed , were compared with the pregnancy outcome of 21 women with gestational diabetes treated conventionally with insulin .  The pregnancy outcome , with regard to the overall glycaemic control , rates of preterm labour , neonatal hypoglycaemia , fetal macrosomia , perinatal morbidity and mortality , were not statistically different between the two treatment groups . The limited number of women studied , and the non-r and om allocation of these women to each treatment group however , could have influenced these results . There were a few observed differences in the pregnancy outcome between the two treatment groups , which although were not statistically significant , caused some concern . In particular we noted an increased rate of fetal macrosomia in the glibenclamide treated group , which in theory could have been drug mediated Insulin is currently the drug of choice in treating patients with gestational diabetes mellitus but insulin is expensive , inconvenient to store and use and probably associated with more risks of asymptomatic hypoglycemia in comparison with some oral agents . This r and omized clinical trial was conducted to evaluate the efficacy and safety of glyburide in patients with gestational diabetes mellitus in comparison with insulin therapy .  Pregnant women aged between 18 - 45 years with singleton pregnancies and in their 24 - 36 weeks of gestation were assessed for eligibility . Women with gestational diabetes mellitus were r and omly allocated to two insulin and glyburide groups and compared with maternal and neonatal outcome . Ninety-six women with gestational diabetes mellitus enrolled in the study . At screen and treated fasting and post-pr and ial blood glucose levels were similar in both groups . Time for beginning the treatment to control the glycemic index was 28.30 ( ±20.60 ) days in the insulin group and 22.56 ( ±18.86 ) in the glyburide group . There was no statistically significant difference in time-to-control the blood glucose level in two studied group . Time , between beginning the treatment of GDM and delivery , was 53.22 ( ±28.96 ) days in the insulin group and 56.67 ( ±30.47 ) in the glyburide group . There was no statistically significant difference between the times of treatment-to-delivery in two studied groups . There were no statistically significant differences between maternal and neonatal outcomes in two studied groups . Glyburide  can effectively and safely control the glycemic index in women with gestational diabetes mellitus in comparison with insulin Importance R and omized trials have not focused on neonatal complications of glyburide for women with gestational diabetes . Objective To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes . Design , Setting s , and Participants The Insulin Daonil trial ( INDAO ) , a multicenter noninferiority r and omized trial conducted between May 2012 and November 2016 ( end of participant follow-up ) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation . Interventions Women who required pharmacologic treatment after 10 days of dietary intervention were r and omly assigned to receive glyburide ( n=460 ) or insulin ( n=454 ) . The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses , up to a maximum of 20 mg/d . The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations . Main Outcomes and Measures The primary outcome was a composite criterion including macrosomia , neonatal hypoglycemia , and hyperbilirubinemia . The noninferiority margin was set at 7 % based on a 1-sided 97.5 % confidence interval . Results Among the 914 patients who were r and omized ( mean age , 32.8 [ SD , 5.2 ] years ) , 98 % completed the trial . In a per- protocol analysis , 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups , respectively . The frequency of the primary outcome was 27.6 % in the glyburide group and 23.4 % in the insulin group , a difference of 4.2 % ( 1-sided 97.5 % CI , −∞ to 10.5 % ; P=.19 ) . Conclusion and Relevance This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications . These findings do not justify the use of glyburide as a first-line treatment . Trial Registration clinical trials.gov Identifier : BACKGROUND Metformin is a logical treatment for women with gestational diabetes mellitus , but r and omized trials to assess the efficacy and safety of its use for this condition are lacking . METHODS We r and omly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin ( with supplemental insulin if required ) or insulin . The primary outcome was a composite of neonatal hypoglycemia , respiratory distress , need for phototherapy , birth trauma , 5-minute Apgar score less than 7 , or prematurity . The trial was design ed to rule out a 33 % increase ( from 30 % to 40 % ) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin . Secondary outcomes included neonatal anthropometric measurements , maternal glycemic control , maternal hypertensive complications , postpartum glucose tolerance , and acceptability of treatment . RESULTS Of the 363 women assigned to metformin  , 92.6 % continued to receive metformin until delivery and 46.3 % received supplemental insulin . The rate of the primary composite outcome was 32.0 % in the group assigned to metformin and 32.2 % in the insulin group ( relative risk , 0.99 [ corrected ] ; 95 % confidence interval , 0.80 [ corrected ] to 1.23 [ corrected ] ) . More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again ( 76.6 % vs. 27.2 % , P<0.001 ) . The rates of other secondary outcomes did not differ significantly between the groups . There were no serious adverse events associated with the use of metformin . CONCLUSIONS In women with gestational diabetes mellitus , metformin ( alone or with supplemental insulin ) is not associated with increased perinatal complications as compared with insulin . The women preferred metformin to insulin treatment . ( Australian New Zeal and Clinical Trials Registry number , 12605000311651 . ) OBJECTIVE : To estimate the magnitude of transplacental transfer of glyburide in women with gestational diabetes mellitus ( GDM ) . METHODS : A prospect i ve , observational study was conducted on women with GDM on glyburide therapy .  On delivery admission , the glyburide dose and time of last dose were recorded . Immediately postdelivery , maternal and umbilical venous blood sample s were obtained and the concentrations of glybur 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 aim ed at comparing the effect of glibenclamide and insulin on neonatal outcomes in women with gestational diabetes mellitus . Methods : In this r and omized 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 r and omly 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 Objective . To examine perinatal outcomes in women with gestational diabetes mellitus treated with glyburide  compared to insulin injections . Study design . This is a retrospective cohort study of women diagnosed with gestational diabetes mellitus ( GDM ) who required pharmaceutical therapy and were enrolled in the Sweet Success California Diabetes and Pregnancy Program between 2001 and 2004 , a California state-wide program . Women managed with glyburide were compared to women treated with insulin injections . Perinatal outcomes were compared using chi-square test and multivariable logistic regression models ; statistical significance was indicated by p < 0.05 and 95 % confidence intervals ( CI ) . Results . Among the 10,682 women with GDM who required medical therapy and met study criteria , 2073 ( 19.4 % ) received glyburide and 8609 ( 80.6 % ) received subcutaneous insulin injections . Compared to insulin therapy and controlling for confounders , oral hypoglycemic treatment was associated with increased risk of birthweight > 4000 g ( aOR = 1.29 ; 95 % CI [ 1.03–1.64 ] ) , and admission to the intensive care nursery ( aOR = 1.46 [ 1.07–2.00 ] ) . Conclusion . Neonates born to women with gestational diabetes managed on glyburide , and were more likely to be macrosomic and to be admitted to the intensive care unit compared to those treated with insulin injections . These findings should be examined in a large , prospect i ve trial Context Metformin is used in pregnancy in women with gestational diabetes mellitus , polycystic ovary syndrome ( PCOS ) , and obesity .  Metformin passes the placenta . Objective To explore the effects of metformin use in PCOS pregnancies on offspring growth to 4 years of age . Design Follow-up study of two r and omized , double-blind , placebo-controlled trials . Setting Secondary care centers . Eleven public hospitals in Norway . Participants One hundred eighty-two children of mothers with PCOS who participated in two r and omized controlled trials . Intervention Metformin 1700 or 2000 mg/d or placebo from first trimester to delivery in the original studies . No intervention in the current study . Main Outcome Measures Height , weight , body mass index ( BMI ) , and overweight/obesity at 4 years of age and head circumference at 1 year of age , converted to z scores . Results The difference in height z score means between the groups at 4 years of age was nonsignificant ( 0.07 [ 95 % confidence interval ( CI ) : -0.22 to 0.36 ] ; P = 0.651 ) . At 4 years of age , the metformin group had higher weight z score than the placebo group [ difference in means : 0.38 ( 0.07 to 0.69 ) ; P = 0.017 ] and higher BMI z score [ difference in means : 0.45 ( 0.11 to 0.78 ) ; P = 0.010 ] . There were more overweight/obese children in the metformin group [ 26 ( 32 % ) ] than in the placebo group [ 14 ( 18 % ) ] at 4 years of age [ odds ratio : 2.17 ( 1.04 to 4.61 ) ; P = 0.038 ] . The difference in mean head circumference z score at 1 year of age was 0.27 ( -0.04 to 0.58 ; P = 0.093 ) . Conclusion Metformin-exposed  children had higher BMI and increased prevalence of overweight/obesity at 4 years of age The  pregnancy  outcome of 33 women with gestational diabetes who were treated with glibenclamide and changed to insulin if glibenclamide failed , were compared with the pregnancy outcome of 21 women with gestational diabetes treated conventionally with insulin .  The pregnancy outcome , with regard to the overall glycaemic control , rates of preterm labour , neonatal hypoglycaemia , fetal macrosomia , perinatal morbidity and mortality , were not statistically different between the two treatment groups . The limited number of women studied , and the non-r and om allocation of these women to each treatment group however , could have influenced these results . There were a few observed differences in the pregnancy outcome between the two treatment groups , which although were not statistically significant , caused some concern . In particular we noted an increased rate of fetal macrosomia in the glibenclamide treated group , which in theory could have been drug mediated Insulin is currently the drug of choice in treating patients with gestational diabetes mellitus but insulin is expensive , inconvenient to store and use and probably associated with more risks of asymptomatic hypoglycemia in comparison with some oral agents . This r and omized clinical trial was conducted to evaluate the efficacy and safety of glyburide in patients with gestational diabetes mellitus in comparison with insulin therapy .  Pregnant women aged between 18 - 45 years with singleton pregnancies and in their 24 - 36 weeks of gestation were assessed for eligibility . Women with gestational diabetes mellitus were r and omly allocated to two insulin and glyburide groups and compared with maternal and neonatal outcome . Ninety-six women with gestational diabetes mellitus enrolled in the study . At screen and treated fasting and post-pr and ial blood glucose levels were similar in both groups . Time for beginning the treatment to control the glycemic index was 28.30 ( ±20.60 ) days in the insulin group and 22.56 ( ±18.86 ) in the glyburide group . There was no statistically significant difference in time-to-control the blood glucose level in two studied group . Time , between beginning the treatment of GDM and delivery , was 53.22 ( ±28.96 ) days in the insulin group and 56.67 ( ±30.47 ) in the glyburide group . There was no statistically significant difference between the times of treatment-to-delivery in two studied groups . There were no statistically significant differences between maternal and neonatal outcomes in two studied groups . Glyburide  can effectively and safely control the glycemic index in women with gestational diabetes mellitus in comparison with insulin Importance R and omized trials have not focused on neonatal complications of glyburide for women with gestational diabetes . Objective To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes . Design , Setting s , and Participants The Insulin Daonil trial ( INDAO ) , a multicenter noninferiority r and omized trial conducted between May 2012 and November 2016 ( end of participant follow-up ) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation . Interventions Women who required pharmacologic treatment after 10 days of dietary intervention were r and omly assigned to receive glyburide ( n=460 ) or insulin ( n=454 ) . The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses , up to a maximum of 20 mg/d . The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations . Main Outcomes and Measures The primary outcome was a composite criterion including macrosomia , neonatal hypoglycemia , and hyperbilirubinemia . The noninferiority margin was set at 7 % based on a 1-sided 97.5 % confidence interval . Results Among the 914 patients who were r and omized ( mean age , 32.8 [ SD , 5.2 ] years ) , 98 % completed the trial . In a per- protocol analysis , 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups , respectively . The frequency of the primary outcome was 27.6 % in the glyburide group and 23.4 % in the insulin group , a difference of 4.2 % ( 1-sided 97.5 % CI , −∞ to 10.5 % ; P=.19 ) . Conclusion and Relevance This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications . These findings do not justify the use of glyburide as a first-line treatment . Trial Registration clinical trials.gov Identifier : BACKGROUND Metformin is a logical treatment for women with gestational diabetes mellitus , but r and omized trials to assess the efficacy and safety of its use for this condition are lacking . METHODS We r and omly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin ( with supplemental insulin if required ) or insulin . The primary outcome was a composite of neonatal hypoglycemia , respiratory distress , need for phototherapy , birth trauma , 5-minute Apgar score less than 7 , or prematurity . The trial was design ed to rule out a 33 % increase ( from 30 % to 40 % ) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin . Secondary outcomes included neonatal anthropometric measurements , maternal glycemic control , maternal hypertensive complications , postpartum glucose tolerance , and acceptability of treatment . RESULTS Of the 363 women assigned to metformin  , 92.6 % continued to receive metformin until delivery and 46.3 % received supplemental insulin . The rate of the primary composite outcome was 32.0 % in the group assigned to metformin and 32.2 % in the insulin group ( relative risk , 0.99 [ corrected ] ; 95 % confidence interval , 0.80 [ corrected ] to 1.23 [ corrected ] ) . More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again ( 76.6 % vs. 27.2 % , P<0.001 ) . The rates of other secondary outcomes did not differ significantly between the groups . There were no serious adverse events associated with the use of metformin . CONCLUSIONS In women with gestational diabetes mellitus , metformin ( alone or with supplemental insulin ) is not associated with increased perinatal complications as compared with insulin . The women preferred metformin to insulin treatment . ( Australian New Zeal and Clinical Trials Registry number , 12605000311651 . ) OBJECTIVE : To estimate the magnitude of transplacental transfer of glyburide in women with gestational diabetes mellitus ( GDM ) . METHODS : A prospect i ve , observational study was conducted on women with GDM on glyburide therapy .  On delivery admission , the glyburide dose and time of last dose were recorded . Immediately postdelivery , maternal and umbilical venous blood sample s were obtained and the concentrations of glybur 
    Output:
    