A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes Metformin should be considered in the treatment of gestational diabetes: a prospective randomised study Intensive low-glycaemic-load dietary intervention for the management of glycaemia and serum lipids among women with gestational diabetes: a randomized control trial. Metformin versus insulin treatment in gestational diabetes in pregnancy in a developing country: a randomized control trial. [Glibenclamide in the treatment for gestational diabetes mellitus in a compared study to insulin]. Perinatal impact of the use of metformin and glyburide for the treatment of gestational diabetes mellitus The effect of DASH diet on pregnancy outcomes in gestational diabetes: a randomized controlled clinical trial Combination of direct and indirect evidence in mixed treatment comparisons. Association between hyperglycaemia and adverse perinatal outcomes in south Asian and white British women: analysis of data from the Born in Bradford cohort A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. Comparison of Newborn Outcomes in Women with Gestational Diabetes Mellitus Treated with Metformin or Insulin: A Randomised Blinded Trial The Society for Social Medicine John Pemberton Lecture 2011. Developmental overnutrition--an old hypothesis with new importance? Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin. Pharmaceutical care of patients with gestational diabetes mellitus. Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide – A randomised controlled trial A randomised controlled trial of dietary energy restriction in the management of obese women with gestational diabetes Investigating the effects of treatment based on single high blood glucose in gestational diabetes screening on maternal and neonatal complications Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial. The Potential Diabetic and Her Treatment in Pregnancy Treatment of women with an abnormal glucose challenge test (but a normal oral glucose tolerance test) decreases the prevalence of macrosomia. The effect of diet on pregnancy outcomes among pregnant with abnormal glucose challenge test. A comparison of glyburide and insulin in women with gestational diabetes mellitus. A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. Randomized trial of metformin vs insulin in the management of gestational diabetes. Glyburide as treatment option for gestational diabetes mellitus.
Background There are no r and omised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus ( GDM ) diagnosed by the International Association of Diabetes and Pregnancy Study Group ’s ( IADPSG ) criteria . We tested the effectiveness of lifestyle modifications implemented in a 3-tier ’s shared care ( SC ) on pregnancy outcomes of GDM . Methods Between December 2010 and October 2012 , we r and omly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 ( interquartile range : 25.4 - 27.3 ) gestational weeks in Tianjin , China , to receive SC or usual care ( UC ) . The SC group received individual consultations and group sessions and performed regular self-monitoring of blood glucose compared to one hospital-based education session in the UC group . The outcomes were macrosomia defined as birth weight ≥ 4.0 kg and the pregnancy-induced hypertension ( PIH ) . Results Women in the SC ( n = 339 ) and UC ( n = 361 ) groups delivered their infants at similar gestational weeks . Birth weight of infants in the SC group was lower than that in the UC group ( 3469 vs. 3371 grams , P = 0.021 ) . The rate of macrosomia was 11.2 % ( 38/339 ) in the SC group compared to 17.5 % ( 63/361 ) in the UC group with relative risk ( RR ) of 0.64 ( 95 % CI : 0.44 - 0.93 ) . The rate of PIH was 8.0 % ( 27/339 ) in the SC compared to 4.4 % ( 16/361 ) in the UC with RR of 1.80 ( 0.99 - 3.28 ) . Apgar score at 1 min < 7 was lower but preeclampsia was higher in the SC than in the UC . Conclusions Lifestyle modifications using a SC system  improved pregnancy outcomes in Chinese women with GDM.Trial registration Clinical trials.gov ; NCT01565564 Please cite this paper as : Ijäs H , Vääräsmäki M , Morin‐Papunen L , Keravuo R , Ebeling T , Saarela T , Raudaskoski T. Metformin should be considered in the treatment of gestational diabetes : a prospect i ve r and omised study . BJOG 2011;118:880–885 OBJECTIVE The present study aim ed to compare the effects of a general dietary intervention and an intervention with low glycaemic load ( GL ) on glycaemic control , blood lipid metabolism and pregnancy outcomes in women with gestational diabetes mellitus . DESIGN Participants were r and omly assigned to two groups , receiving either an individualized general dietary intervention ( Control group ) or an intensive low-GL intervention ( Low-GL group ) every two weeks , from 24 - 26 weeks of gestation to delivery . SETTING The Center of Maternal Primary Care in Guangdong General Hospital , China . SUBJECTS Ninety-five women with gestational diabetes mellitus were enrolled from June 2008 to July 2009 . RESULTS After the intervention , both groups significantly decreased their dietary intakes of energy , fat and carbohydrate . The Low-GL group had significantly lower values for GL ( 122 v. 136 ) and glycaemic index ( 50 v. 54 ) but greater dietary fibre intake ( 33 v. 29 g/d ) than did the Control group ( all P<0·01 ) . Significantly greater decreases in fasting plasma glucose ( -0·33 v. -0·02 mmol/l , P<0·01 ) and 2 h postpr and ial glucose ( -2·98 v. -2·51 mmol/l , P<0·01 ) , significantly lower increases in total cholesterol ( 0·12 v. 0·23 mmol/l ) and TAG ( 0·41 v. 0·56 mmol/l ) and a significantly lower decrease in HDL cholesterol ( -0·01 v. -0·11 mmol/l ) were also observed in the Low-GL group compared with the Control group ( all P<0·05 ) . There were no significant differences in body weight gain , birth weight or other maternal-fetal perinatal outcomes between the two groups . CONCLUSIONS The low-GL targeted dietary intervention outperformed the general dietary intervention in glycaemic control and the improvement of blood lipid levels in women with gestational diabetes mellitus AIM To compare treatment with metformin alone , metformin plus insulin and insulin alone in women with gestational diabetes ( GDM ) . METHOD A total of 150 gestational diabetic patients who fulfilled the eligibility criteria were included in this prospect i ve r and omized control open labeled study . A risk factor based screening was done followed by a GCT and then local GTT criteria from antenatal clinics . They were initially divided into two groups with odd numbers assigned to metformin treatment and even numbers to insulin treatment . Metformin and /or insulin treatment was given and target blood sugar levels aim ed at FBS ≤ 100 mg/dl and postpr and ial levels ≤ 126 mg/dl . Supplemental insulin was added to metformin treatment group to maintain the glycemic targets if required . Patients were followed until delivery and maternal fetal outcomes and pharmacotherapeutic characteristics were recorded on a performa . RESULTS Less maternal weight gain was found in the metformin treated groups ( 9.8 ± 1.5 kg [ metformin alone ] vs. 9.8 ± 1.4 kg [ metformin plus insulin ] vs. 12.5 ± 1.1 kg [ insulin alone ] P < 0.000 ) . Preeclampsia was significantly less in metformin treated groups . There were no perinatal deaths in the study . Mean birth weight was significantly less in metformin treated groups ( 3.4 ± 0.4 kg vs. 3.3 ± 0.5 kg vs. 3.7 ± 0.5 kg P < 0.01 ) . Less neonatal morbidity was observed in metformin groups . 42.7 % of patients required supplemental insulin ( mean dose of 13.6 ± 2 units ) in the  metformin group . Mean gestational age at which insulin was added was 31.8 ± 5.9 weeks . CONCLUSION Metformin is an effective and cheap treatment option for women with gestational diabetes with or without supplemental insulin 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 r and omized 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 r and omized 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 postpr and ial 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 Abstract Objective : To evaluate the perinatal impact of metformin and glyburide in the treatment of gestational diabetes mellitus ( GDM ) . Methods : A r and omized clinical trial conducted from July 2008 until September 2010 studied 200 pregnant women with GDM who required adjunctive therapy to diet and physical activity . Patients were r and omized to use metformin ( n=104 ) or glyburide ( n=96 ) . The drugs were replaced by insulin when they reached the maximum dose without glycemic control . Assessed outcomes : weight and neonatal blood glucose . Results : : No difference was found ( P>0.05 ) between the groups regarding maternal age , gestational age at inclusion , body mass index , glucose levels in oral glucose tolerance test ( OGTT ) 75 g and glycemic control . Difference was found in the number of previous pregnancies ( 2.84 vs. 2.47 , P=0.04 ) and weight gain during pregnancy ( 7.78 vs. 9.84 , P=0.04 ) in the metformin group and glyburide respectively . The perinatal results showed no difference ( P>0.05 ) in the percentage of cesarean deliveries , gestational age at delivery , number of newborns large for gestational age ( LGA ) , neonatal hypoglycemia , admission to intensive care unit and perinatal death . We found differences in weight ( 3193 g vs. 3387 g , P=0.01 ) and ponderal index ( 2.87 vs. 2.96 , P=0.05 ) of newborns , and in neonatal blood glucose levels at the 1st ( 59.78 vs. 54.08 , P=0.01 ) and 3rd h ( 61.53 vs. 55.89 , P=0.01 ) after birth between the metformin and glyburide groups respectively . Conclusions : Weight and ponderal index were lower in the newborns of the metformin group ; glucose levels ( 1st and 3rd h after birth ) were lower in the glyburide group Background / Objectives : The current study was performed to investigate the effects of the Dietary Approaches to Stop Hypertension ( DASH ) eating plan on pregnancy outcomes in pregnant women with gestational diabetes mellitus (GDM).Subjects/ Methods : This r and omized controlled clinical trial was performed among 52 women diagnosed with GDM . Participants were r and omly assigned to consume either the control ( n=26 ) or the DASH diet ( n=26 ) for 4 weeks . The control diet was design ed to contain 45–55 % carbohydrates , 15–20 % protein and 25–30 % total fat . The DASH diet was rich in fruits , vegetables , whole grains and low-fat dairy products , and contained lower amounts of saturated fats , cholesterol and refined grains with a total of 2400 mg/day sodium . The numbers of women who commenced insulin therapy after dietary intervention , the mode of delivery and prevalence of polyhydramnios were assessed . The length , weight and head circumference of infants were measured during the first 24 h after birth . Results : Whereas 46.2 % of women in the DASH diet needed to have a cesarean section , this percentage for the control group was 80.8 % ( P=0.01 ) . The percentage of those who needed to commence insulin therapy after intervention was also significantly different between the two groups ( 23 % for DASH vs 73 % for control group , P<0.0001 ) . Infants born to mothers on the DASH diet had significantly lower weight ( 3222.7 vs 3818.8 g , P<0.0001 ) , head circumference ( 34.2 vs 35.1 cm , P=0.01 ) and ponderal index ( 2.50 vs 2.87 kg/m3 , P<0.0001 ) compared with those born to mothers on the control diet . Conclusions : In conclusion , consumption of DASH diet for 4 weeks among pregnant women with GDM result ed in improved pregnancy outcomes Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Summary Background Diagnosis of gestational diabetes predicts risk of infants who are large for gestational age ( LGA ) and with high adiposity , which in turn aims to predict a future risk of obesity in the offspring . South Asian women have higher risk of gestational diabetes , lower risk of LGA , and on average give birth to infants with greater adiposity than do white European women . Whether the same diagnostic criteria for gestational diabetes should apply to both groups of women is unclear . We aim ed to assess the association between maternal glucose and adverse perinatal outcomes to ascertain whether thresholds used to diagnose gestational diabetes should differ between south Asian and white British women . We also aim ed to assess whether ethnic origin affected prevalence of gestational diabetes irrespective of criteria used . Methods We used data ( including results of a 26–28 week gestation oral glucose tolerance test ) of women from the Born in Bradford study , a prospect i ve study that recruited women attending the antenatal clinic at the Bradford Royal Infirmary , UK , between 2007 and 2011 and who intended to give birth to their infant in that hospital . We studied the association between fasting and 2 h post-load glucose and three primary outcomes ( LGA [ defined as birthweight > 90th percentile for gestational age ] , high infant adiposity [ sum of skinfolds > 90th percentile for gestational age ] , and caesarean section ) . We calculated adjusted odds ratios ( ORs ) and their 95 % confidence intervals ( CIs ) for a 1 SD increase in fasting and post-load glucose . We established fasting and post-load glucose thresholds that equated to an OR of 1·75 for LGA and high infant adiposity in each group of women to identify ethnic-specific criteria for diagnosis of gestational diabetes . Findings Of 13 773 pregnancies , 3420 were excluded from analyses . Of 10 353 eligible pregnancies , 4088 women were white British , 5408 were south Asian , and 857 were of other ethnic origin . The adjusted ORs of LGA per 1 SD fasting glucose were 1·22 ( 95 % CI 1·08–1·38 ) in white British women and 1·43 ( 1·23–1·67 ) in south Asian women ( pinteraction with ethnicity = 0·39 ) . Results for high infant adiposity were 1·35 ( 1·23–1·49 ) and 1·35 ( 1·18–1·54 ; pinteraction with ethnicity=0·98 ) , and for caesarean section they were 1·06 ( 0·97–1·16 ) and 1·11 ( 1·02–1·20 ; pinteraction with ethnicity=0·47 ) . Associations between post-load glucose and the three primary outcomes were weaker than for fasting glucose . A fasting glucose concentration of 5·4 mmol/L or a 2 h post-load level of 7·5 mmol/L identified white British women with 75 % or higher relative risk of LGA or high infant adiposity ; in south Asian women , the cutoffs were 5·2 mmol/L or 7·2 mml/L ; in the whole cohort , the cutoffs were 5·3 mmol/L or 7·5 mml/L. The prevalence of gestational diabetes in our cohort ranged from 1·2 % to 8·7 % in white British women and 4 % to 24 % in south Asian women using six different criteria . Compared with the application of our whole-cohort criteria , use of our ethnic-specific criteria increased the prevalence of gestational diabetes in south Asian women from 17·4 % ( 95 % CI 16·4–18·4 ) to 24·2 % ( 23·1–25·3 ) . Interpretation Our data support the use of lower fasting and post-load glucose thresholds to diagnose gestational diabetes in south Asian than white British women . They also suggest that diagnostic criteria for gestational diabetes recommended by UK NICE might underestimate the prevalence of gestational diabetes compared with our criteria or those recommended by the International Association of Diabetes and Pregnancy Study Groups and WHO , especially in south Asian women . Funding The National Institute for Health Research OBJECTIVES The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes lessened the risk of fetal macrosomia , birth trauma , neonatal hypoglycemia , and operative delivery . The aim of the pilot study was to prepare for a multicenter trial by assessing patient acceptance of the study , by determining realistic accrual rates , and by detecting any major adverse outcomes in the control group that received routine obstetric care . STUDY DESIGN The study was a prospect i ve r and omized controlled trial comparing fetal-neonatal and maternal outcomes in 300 women with gestational diabetes . Women r and omized to the treatment arm were managed by strict glycemic control and tertiary level obstetric care , and women in the control arm received routine obstetric care . RESULTS Three hundred women with gestational diabetes mellitus were studied . There was no difference in maternal age , weight , or length of gestation between groups . The treatment mean birth weight was 3437 + /- 575 gm compared with 3544 + /- 601 gm in the control group , a difference of 107 gm ( not significant ) . Macrosomia rates were similar . There was no birth trauma in either group . The frequency of neonatal hypoglycemia and other metabolic complications was the same . The mode of delivery also showed similar patterns . The treatment group had significantly lower prepr and ial and postpr and ial glucose levels by 32 weeks ' gestation , which continued to term . CONCLUSION This pilot study suggests that intensive treatment of gestational diabetes mellitus may have little effect on birth weight , birth trauma , operative delivery , or neonatal metabolic disorders . It has demonstrated the safety of proceeding to a multicenter trial of sufficient sample size to confirm these findings BACKGROUND We conducted a r and omized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications . METHODS We r and omly assigned women between 24 and 34 weeks ' gestation who had gestational diabetes to receive dietary advice , blood glucose monitoring , and insulin therapy as needed ( the intervention group ) or routine care . Primary outcomes included serious perinatal complications ( defined as death , shoulder dystocia , bone fracture , and nerve palsy ) , admission to the neonatal nursery , jaundice requiring phototherapy , induction of labor , cesarean birth , and maternal anxiety , depression , and health status . RESULTS The rate of serious perinatal complications was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group ( 1 percent vs. 4 percent ; relative risk adjusted for maternal age , race or ethnic group , and parity , 0.33 ; 95 percent confidence interval , 0.14 to 0.75 ; P=0.01 ) . However , more infants of women in the intervention group were admitted to the neonatal nursery ( 71 percent vs. 61 percent ; adjusted relative risk , 1.13 ; 95 percent confidence interval , 1.03 to 1.23 ; P=0.01 ) . Women in the intervention group had a higher rate of induction of labor than the women in the routine-care group ( 39 percent vs. 29 percent ; adjusted relative risk , 1.36 ; 95 percent confidence interval , 1.15 to 1.62 ; P<0.001 ) , although the rates of cesarean delivery were similar ( 31 percent and 32 percent , respectively ; adjusted relative risk , 0.97 ; 95 percent confidence interval , 0.81 to 1.16 ; P=0.73 ) . At three months post partum , data on the women 's mood and quality of life , available for 573 women , revealed lower rates of depression and higher scores , consistent with improved health status , in the intervention group . CONCLUSIONS Treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman 's health-related quality of life AIMS We compared metformin with insulin as treatment of gestational diabetes mellitus ( GDM ) . Furthermore , we aim ed to characterize  metformin-treated patients needing additional insulin to achieve prespecified glucose targets . METHODS We conducted a single centre r and omized controlled study with non-inferiority design comparing metformin and insulin in the treatment of 217 GDM patients having birth weight as primary outcome variable . RESULTS There were no significant differences in mean birth weight expressed in grams [ + 15 ( 90 % confidence interval ( CI ) : -121 to 89 ) ] or SD units [ + 0.04 ( 90 % CI : -0.27 to 0.18 ) ] between the metformin and insulin groups . There were no significant differences in neonatal or maternal data between the groups . Only 23 ( 20.9 % ) of the 110 patients in the metformin group needed additional insulin .  Compared with the patients on metformin only , those needing additional insulin  were older ( p = 0.04 ) , their oral glucose tolerance test had been performed earlier and diabetes therapy started earlier in gestation ( p = 0.01 and p = 0.004 , respectively ) . The risk for additional insulin was 4.6-fold in women with baseline serum fructosamine concentration above median compared with those below median . CONCLUSIONS Metformin is an effective alternative to insulin in the treatment of GDM patients . Serum fructosamine may help in predicting the adequacy of metformin treatment alone OBJECTIVE To compare glycemic control and neonatal outcomes in women with gestational diabetes mellitus ( GDM ) treated with metformin vs. insulin . STUDY DESIGN Women with GDM not controlled with diet and exercise were r and omized to metformin ( n = 32 ) or insulin ( n = 31 ) . The levels of glycemic control as well as maternal/neonatal complications were evaluated . RESULTS The mean ( + /- SD ) fasting and 2-hour postpr and ial blood glucose did not differ statistically between the 2 treatment groups . No patient failed metformin and required insulin . The majority ( 27/32 ) were easily controlled on the initial dosage ( 500 mg twice a day ) . Gestational age at entry and delivery ( p = 0.077 , 0.412 ) were similar . The difference in the rate of cesarean delivery was not statistically significant between the 2 groups ( p = 0.102 ) . Neonatal statistics were also not different between the metformin and insulin groups : birth weight , Apgar score at 5 minutes , respiratory distress syndrome , hyperbilirubinemia , neonatal hypoglycemia and neonatal intensive care unit admission ( p = 0.144 - 0.373 ) . CONCLUSION Based on these preliminary data , metformin appears to be an effective alternative to insulin in the treatment of GDM Background : Few studies have been done on the use of metformin in pregnancy and their results were not similar , therefore this research is performed to compare neonatal outcomes of metformin and insulin in the treatment of gestational diabetes . Methods : In this prospect i ve r and omized trial , 200 pregnant women within their 24th to 34th weeks of gestation with gestational diabetes , single fetus pregnancy , and in need of hyperglycemia treatment were entered and grouped as either metformin or insulin . Data related to maternal and neonatal outcomes were recorded and analyzed . Results : Considering data recorded of HbA1c at the beginning of pregnancy , pregnancy induced hypertension , preeclampsia , birth weight , dystocia , first and 5th min APGAR , neonatal sepsis , rout of delivery , liver function tests of neonate , hypoglycemia , anomaly , and still birth , there were no significant statistical differences between groups . The end pregnancy HbA1c , maternal weight gain during pregnancy , preterm labor , neonatal jaundice , respiratory distress and hospitalization of infants were higher in insulin group . Conclusions : Considering data from this study , metformin is efficient to control hyperglycemia in pregnancy . It is suggested performing more studies to evaluate long term side effects of metformin in pregnancy with higher sample size and longer follow-up of newborns This paper is concerned with whether mothers who are more adipose or have higher glucose levels during pregnancy may overfeed their developing infants in utero and in doing so may set them on a pathway to greater adiposity throughout their lives . If this is the case , then the more adipose daughters of these mothers may also subsequently overfeed their infants in utero , thereby perpetuating the risk of greater adiposity across generations . I begin with the historical context of how gestational diabetes was first recognized and early evidence that diabetes in pregnancy results in increased birth size and adiposity . I then consider four questions , which are the main focus of the paper . Each of the four questions involves an exposure during pregnancy and evidence concerned with whether the exposure is causally related to offspring adiposity via intra-uterine mechanisms . The four related exposures are : ( i ) pregnancy diabetes ; ( ii ) extreme maternal pregnancy obesity ( 440 kg/m or meeting criteria for bariatric surgery ) ; ( iii ) incrementally greater pre-/early pregnancy adiposity across the whole distribution seen in pregnant women ; and ( iv ) gestational weight gain . Since r and omized controlled trial evidence is not available I focus on methods that can provide the best causal evidence from observational data such as negative control studies , family comparisons and using genetic variants as instrumental variables ( i.e. Mendelian r and omization studies ) . Having addressed these four questions I go on to briefly discuss the possible role of epigenetic modification mediating any effects of maternal exposures on offspring outcomes . I conclude with a discussion about the future research and policy implication s of evidence to date in this field OBJECTIVE We hypothesized that body composition would be similar among neonates of women with gestational diabetes ( GDM ) treated with glyburide or insulin . STUDY DESIGN Women with GDM requiring medical therapy were r and omized to insulin or glyburide . The primary outcome was percent neonatal fat mass measured by total body electrical conductivity . Secondary outcomes included anthropometrics , glycemic control , and biomarkers . Statistical analysis included Student t test , chi(2 ) , and regression modeling . RESULTS Eighty-two neonates underwent postnatal measurements . Baseline factors were not different by group . Neonatal percent fat mass did not differ between treatment groups ( 11.2 + /- 4.2 vs 12.8 + /- 5.7 ) . Fat mass , body mass index , ponderal index , skinfold sum , and arm fat area were not different when analyzed by intent to treat or actual treatment group . Cord concentrations of biomarkers were also similar . CONCLUSION There was no difference in neonatal adiposity in infants of women treated for GDM with glyburide or insulin RATIONALE , AIMS AND OBJECTIVE To investigate whether the introduction of a programme of optimising drug treatment , intensive education and self-monitoring of patients diagnosed with gestational diabetes mellitus ( GDM ) at an early stage ( < 20 gestational weeks ) , will improve management outcomes as determined by objective measures of patient knowledge about diabetes , glycaemia control , maternal/neonatal complications , and health-related quality of life . METHODS The study was a r and omized , controlled , longitudinal , prospect i ve clinical trial performed at Al-Ain Hospital , Al-Ain , United Arab Emirates . Over an 18-month period , patients diagnosed with GDM were recruited and were r and omly assigned to either an intervention or a control group , in a ratio of 3:2 . Intervention patients received a structured pharmaceutical care service ( including education and introduction of intensive self-monitoring ) while control patients received traditional services . Patients were followed up from time of recruitment until 6 months postnatally at scheduled outpatient clinics . A range of clinical and humanistic outcome measures , including maternal and neonatal complications , were used to assess the impact of the intervention . RESULTS A total of 165 patients ( 99 intervention , 66 control ) completed the study . The intervention patients exhibited a range of benefits from the provision of the programme when compared with control group patients . Statistically significant ( P < 0.05 ) improvements were shown in the intervention group for knowledge of diabetes , health-related quality of life ( as determined by the SF36 ) , control of plasma glucose and HbA(1c ) , maternal complications [ e.g. decreased incidence of pre-eclampsia ( 5.1 % vs. 16.7 % ) , eclampsia ( 1.0 % vs. 7.6 % ) , episodes of severe hyperglycaemia ( 3.0 % vs. 19.7 % ) and need for Caesarean section ( 7.1 % vs. 18.2 % ) ] , and neonatal complications [ e.g. decreased incidence of neonatal hypoglycaemia ( 2.0 % vs. 10.6 % ) , respiratory distress at birth ( 4.0 % vs. 15.2 % ) , hyperbilirubinaemia ( 1.0 % vs. 12.1 % ) and large for gestational age ( 9.0 % vs. 22.7 % ) ] . CONCLUSION The research provides clear evidence that provision of pharmaceutical care adds value to the management of GDM as exemplified by improved maternal and neonatal outcomes Two oral hypoglycaemic agents , metformin and glibenclamide , have been compared with insulin in separate large r and omised controlled trials and have been found to be as effective as insulin in gestational diabetes .  However , very few trials have compared metformin with glibenclamide Summary : A r and omised controlled trial was design ed to determine the effect of moderate 30 % maternal dietary energy restriction on the requirement for maternal insulin therapy  and the incidence of macrosomia in gestational diabetes .  Although the control group restricted their intake to a level similar to that of the intervention group ( 6845 kiloJoules ( kJ ) versus 6579 kJ ) , the result ing cohort could not identify any adverse effect of energy restriction in pregnancy . Energy restriction did not alter the frequency of insulin therapy ( 17.5 % in the intervention group and 16.9 % in the control group ) . Mean birth weight  ( 3461 g in the intervention group and 3267 g in the control group ) was not affected . There was a trend in the intervention group towards later gestational age at commencement of insulin therapy ( 33 weeks versus 31 weeks ) and lower maximum daily insulin dose ( 23 units versus 60 units ) which did not reach statistical significance . Energy restriction did not cause an increase in ketonemia Purpose To create a positive step toward achieving an efficient method for gestational diabetes treatment , the present study was carried out to compare the treatment outcomes based on single impaired blood glucose versus regular method in health care centers in Iran . Methods This r and omized clinical trial was carried out in Tehran/Iran between March 2012 and August 2013 . Study sample consisted of mothers whose fasting blood sugar was disturbed or a disturbed blood sugar was seen in OGTT with 75 g glucose load , according to ADA st and ards . For each outcome , multiple logistic regressions were used to control for the effects of potential confounders . When a confounder was measured on a continuous scale ( e.g. , age ) , LOWESS ( locally weighted scatter plot smoothing ) algorithm was used to determine whether the effect of that variable was linear . We also used the fractional polynomial regression to determine the optimal transformation of continuous covariates . Results The information of 189 pregnant women was used in this study ; 87 in the interventional group ( 46 % ) and 102 in the control group ( 54 % ) . Treatment based on the new protocol has very high protective effect ( OR 0.25 , 95 % CI 0.68–0.88 ) in terms of neonatal hyperbilirubinemia . This difference was not seen in other outcomes including stillbirth , macrosomic newborn delivery , hypoglycemia , and hypocalcemia . The risk of neonatal hypoglycemia reduced after the 25th week of gestation ( OR 0.39 , 95 % CI 0.15–0.98 ) . Conclusions Although the treatment of mild gestational diabetes could not significantly decrease severe neonatal outcomes , it did significantly reduce the risk of hyperbilirubinemia and its subsequent complications A r and omized multicenter study was conducted in the Stockholm‐Örebro areas in Sweden to evaluate how treatment aim ing at normoglycemia  affects fetal growth , pregnancy and neonatal outcome in pregnant women with severe hyperglycemia AIMS To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus ( GDM ) . METHODS This r and omized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned r and omly to receive either metformin ( n=80 ) or insulin ( n=80 ) . The primary outcomes were maternal glycemic control and birth weight . The secondary outcomes were neonatal and obstetric complications . RESULTS Two groups were comparable regarding the maternal characteristics . Two groups were similar in mean FBS ( P=0.68 ) and postpr and ial measurements ( P=0.87 ) throughout GDM treatment . The neonates of metformin group had less rate of birth weight centile > 90 than insulin group ( RR : 0.5 , 95 % CI : 0.3 - 0.9 , P=0.012 ) . Maternal weight gain was reduced in the metformin group ( P<0.001 ) . Two groups were comparable according to neonatal and obstetric complications ( P>0.05 ) . In metformin group 14 % of women needed to supplemental insulin to achieve euglycemia . CONCLUSION Metformin is an effective and safe alternative treatment to insulin for women with GDM . This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin The purpose of this study was to examine pregnancy outcome in women with abnormal oral glucose tolerance tests , in relation to treatment with diet and insulin . Glucose tolerance tests , done because of well-known historical risk factors , were considered abnormal if two or more readings exceeded the following : fasting , 110 ; 1 hour , 170 ; 2 hours , 120 ; and 3 hours , 110 ( all in mg/100 mL , measured as total reducing substances in whole venous blood ) . Those with positive tests were divided r and omly into a “ positive-control ” group ( n 308 ) that received  st and ard prenatal care or a “ positive-treated ” group ( n 307 ) that received dietary instructions ( 30 kcal/kg ideal body weight , 40 % as carbohydrate , and 1.5–2 g protein/kg body weight ) and insulin ( initial dose 10 U per day of intermediate-acting insulin , adjusted subsequently as directed by blood and urine studies ) , beginning at usually about 32 weeks . A third group ( n 328 ) , termed “ negative controls , ” had exhibited normal glucose tolerance testing . The three groups were similar , except that those with abnormal glucose tolerance tended to be older and heavier , as expected . With respect to outcome , infants with birth weights exceeding 9 lb were three times as frequent in positive-control subjects as in either positive-treated subjects or negative controls ( 13.1 % , 4.3 % , and 3.7 % , respectively ) . Perinatal deaths ( 28 weeks ’ gestation through 14 days after birth ) were similar in the two positive groups ( 4.9 % in control and 4.3 % in treated ) and significantly higher than in negative controls ( 1.9 % ) , with the increase involving both fetal and neonatal components . The conclusions were 1 ) abnormal glucose tolerance during pregnancy leads to larger infants and higher perinatal mortality and 2 ) treatment with diet and insulin ameliorates the former but not the latter . This study concerned what O’Sullivan called potential diabetes and others at the time termed latent or chemical diabetes or prediabetes , but what today we refer to as gestational diabetes . Acceptance of it as a pathologic entity was far from unanimous in 1966 . O’Sullivan resolved the controversy with this large , well- design ed , and well-analyzed clinical trial . The immediate influence was two-fold . In the first place , it settled the existing disagreement as to whether or not impaired glucose tolerance adversely influences pregnancy outcome ; large infants occurred three times as frequently and perinatal deaths were more than doubled in women with abnormal carbohydrate metabolism . Second , the findings of the intervention trial indicated clearly that treatment of gestational diabetes with diet and insulin in late gestation normalizes birth weight ( although it did not seem to influence perinatal mortality ) , a finding confirmed a number of times by subsequent investigators . Incidentally , the frequencies of both fetal and neonatal deaths may seem high , but it needs to be remembered that this experience ante date d the advent of modern fetal surveillance and neonatal intensive care . John B. O’Sullivan , a pioneer in clinical research in gestational diabetes , was an internist . He defined st and ards for the oral glucose tolerance test in pregnancy that , though modified slightly by subsequent investigators , are basically those in use today . Born in 1926 , he received his medical education in his native Irel and before immigrating to the United States in 1955 . After further training in internal medicine at the Lahey Clinic , he took a faculty position at the Boston University School of Medicine , where he did his original work on early diabetes as medical director of the Prenatal Metabolism Clinic at Boston City Hospital and chief of medicine at St. Margaret ’s Hospital . In addition to his position as Associate Professor at Boston University , he also served on the faculties of the Harvard and Yale medical schools . Later he was director of employee health for the Liberty Mutual Insurance Company . He died of cancer in August 2001 Infant macrosomia is a serious medical concern . Pregnant women who do not meet the specific diagnosis for gestational diabetes may still have glucose-mediated macrosomia . In Santa Barbara County all pregnant women are screened for gestational diabetes at 24 - 28 weeks with a 50-g , 1-hr glucose challenge test ( GCT ) . All patients who fail this test are placed on a st and ard euglycemic diet ( 40 % carbohydrate , 20 % protein , 40 % fat ) and perform home glucose monitoring of fasting and postpr and ial glucose levels . The objective of this study was to examine the effectiveness of this treatment program in decreasing infant macrosomia , maternal and infant morbidity , maternal complications , and operative delivery . We studied 103 women who had a positive GCT , but a negative 100-g , 3-hr oral glucose tolerance test ( OGTT ) . The women were r and omly assigned to either experimental or control groups with experimental women receiving dietary counseling and home glucose monitoring instruction ( HBGM ) . HBGM diaries were review ed weekly by clinic nurses . All women had hemoglobin A1c ( HbA1c ) tests at 28 and 32 weeks . Maternal and fetal charts were review ed to determine delivery type and complications , indications for cesarean section ( C-section ) , and infant gestational age , gender , Apgar scores , birth weight , morbidities , and congenital anomalies . Of the 103 women , 5 women required insulin treatment , 1 woman had an abortion , and 14 women were indeterminate regarding compliance or were control women who received diet counseling and HBGM . The results are based on 83 women--48 control and 35 experimental . There were no significant differences between the groups for age , parity , or weight at 28 - 30 weeks or 37 weeks to delivery , or HbA1c at 28 weeks . HbA1c was significantly higher in control women at 32 weeks . Birth weight expressed in grams or as a percentile specific for gender , ethnicity , and gestational age was significantly higher in control infants . Birth weight was significantly correlated with maternal intake weight , weight at 28 - 30 weeks , and weight at delivery and with HbA1c at 32 weeks ' gestation . There were no significant differences between groups for maternal complications . Groups were significantly different for mode of delivery with experimental women having more induced vaginal deliveries but fewer repeat C-sections than control women . Groups were not different for primary C-sections . Women who fail the GCT , but not the OGTT and thus do not receive the diagnosis of GDM are still at risk for delivering a macrosomic infant and operative delivery . Our program of treatment for all women who fail the GCT improves outcome by reducing infant birth weight and the number of cesarean sections OBJECTIVES Gestational diabetes mellitus ( GDM ) is defined as glucose intolerance , first time detected in pregnancy . Diagnostic criteria for GDM have changed over the decades . The aim of the study was to examine the effect of diet on birth weight , number of large for gestational age ( LGA ) ( birth weight  > 90th percentile ) babies  , total maternal weight gain , gestational age and route of delivery among patients with positive 50 g glucose challenge test ( GCT ) and negative 100 g oral glucose tolerance test ( OGTT ) . PATIENTS AND METHODS A prospect i ve r and omized controlled study was conducted among patients with positive 50 g GCT and negative 100 g OGTT . A plasma glucose value of 140 mg/dL was used as the threshold to define an abnormal GCT result . In group 1 50 patients were given a caloric diet and compared with group 2 with 50 patients without a given diet .  Patients were followed up until delivery and evaluated for birth weight , number of LGA babies , total maternal weight gain , gestational age and route of delivery . RESULTS There were no significant differences between the groups in maternal age , parity , body mass index and gestational age at delivery . There were significant differences in birth weight , number of LGA babies , total maternal weight gain during pregnancy . The mean gestational age at delivery was 38.7±1.2 weeks in group 1 and 38.9±1.1 weeks in group 2 ( p = 0.615 ) . The mean birth weight in group 1 was 3328±399 g and 3623±485 g in group 2 ( p = 0.007 ) , cesarean rate was 32 % in group 1 and 40 % in group 2 ( p = 0.405 ) . CONCLUSIONS In the management of patients with positive 50 g GCT and negative 100 g OGTT , patients who were prescribed medical nutrition therapy by a dietitian experienced in GDM management had better perinatal outcomes BACKGROUND Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug , because of concern about teratogenicity and neonatal hypoglycemia . There is little information about the efficacy of these drugs in this group of women . METHODS We studied 404 women with singleton pregnancies and gestational diabetes that required treatment . The women were r and omly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol . The primary end point was achievement of the desired level of glycemic control . Secondary end points included maternal and neonatal complications . RESULTS The mean ( + /-SD ) pretreatment blood glucose concentration as measured at home for one week was 114+/-19 mg per deciliter ( 6.4+/-1.1 mmol per liter ) in the glyburide group and 116+/-22 mg per deciliter ( 6.5+/-1.2 mmol per liter ) in the insulin group ( P=0.33 ) . The mean concentrations during treatment were 105+/-16 mg per deciliter ( 5.9+/-0.9 mmol per liter ) in the glyburide group and 105+/-18 mg per deciliter ( 5.9+/-1.0 mmol per liter ) in the insulin group ( P=0.99 ) . Eight women in the glyburide group ( 4 percent ) required insulin therapy . There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age ( 12 percent and 13 percent , respectively ) ; who had macrosomia , defined as a birth weight of 4000 g or more ( 7 percent and 4 percent ) ; who had lung complications ( 8 percent and 6 percent ) ; who had hypoglycemia ( 9 percent and 6 percent ) ; who were admitted to a neonatal intensive care unit ( 6 percent and 7 percent ) ; or who had fetal anomalies ( 2 percent and 2 percent ) . The cord-serum insulin concentrations were similar in the two groups , and glyburide was not detected in the cord serum of any infant in the glyburide group . CONCLUSIONS In women with gestational diabetes , glyburide is a clinical ly effective alternative to insulin therapy INTRODUCTION Nutrition therapy is an integral part of the management of gestational diabetes mellitus ( GDM ) . Most women with GDM are treated by nutritional management alone . The goal of our study was to compare low and high carbohydrate diets in their effectiveness , safety and tolerability in women with GDM . MATERIAL AND METHODS The study group consisted of 30 Caucasian women newly diagnosed with GDM , with a mean age of 28.7 + /- 3.7 years and pregnancy duration of 29.2 + /- 5.4 weeks . The patients were r and omised into two groups : those on a low and those on a high carbohydrate diet ( 45 % vs. 65 % respectively of energy supply coming from carbohydrates ) . The presence of urine ketones was controlled every day . After two weeks daily glucose profiles and compliance with the recommended diets were analysed . RESULTS Glucose concentration before implementation of the diet regimen did not differ between groups . No changes in fasting blood glucose were noticed in the group that had followed a low carbohydrate diet , although a significant decrease in glucose concentration was observed after breakfast ( 102 + /- 16 vs. 94 + /- 11 mg/dl ) , lunch ( 105 + /- 12 vs. 99 + /- 9 mg/dl ) and dinner ( 112 + /- 16 vs. 103 + /- 13 mg/dl ) ( p < 0.05 ) . In the high carbohydrate diet group fasting and after-breakfast glucose concentration did not change . A significant decrease in glycaemia was noticed after lunch ( 106 + /- 15 vs. 96 + /- 7 mg/dl ) and dinner ( 107 + /- 12 vs. 97 + /- 7 mg/dl ) ( p < 0.05 ) . Ketonuria was not observed in either group . Obstetrical outcomes did not differ between groups . CONCLUSIONS Both high and low carbohydrate diets are effective and safe . A diet with carbohydrate limitation should be recommended to women who experience the highest glycaemia levels after breakfast OBJECTIVE To evaluate glycemic control in women receiving metformin or insulin for gestational diabetes , and to identify factors predicting the need for supplemental insulin in women initially treated with metformin . STUDY DESIGN Women with gestational diabetes who failed to achieve glycemic control with diet and exercise were r and omized to receive metformin ( n = 47 ) or insulin ( n = 47 ) . Criteria for inclusion were singleton pregnancy , diet , and exercise for a minimum period of 1 week without satisfactory glycemic control , absence of risk factors for lactic acidosis , and absence of anatomic and /or chromosome anomalies of the conceptus . Patients who were lost to prenatal follow-up were excluded . RESULTS Comparison of mean pretreatment glucose levels showed no significant difference between groups ( P = .790 ) . After introduction of the drug , lower mean glucose levels were observed in the metformin group ( P = .020 ) , mainly because of lower levels after dinner ( P = .042 ) . Women using metformin presented less weight gain ( P = .002 ) and a lower frequency of neonatal hypoglycemia ( P = .032 ) . Twelve women in the metformin group ( 26.08 % ) required supplemental insulin for glycemic control . Early gestational age at diagnosis ( odds ratio , 0.71 ; 95 % confidence interval , 0.52 - 0.97 ; P = .032 ) and mean pretreatment glucose level ( odds ratio , 1.061 ; 95 % confidence interval , 1.001 - 1.124 ; P = .046 ) were identified as predictors of the need for insulin . CONCLUSION Metformin was found to provide adequate glycemic control with lower mean glucose levels throughout the day , less weight gain and a lower frequency of neonatal hypoglycemia . Logistic regression analysis showed that gestational age at diagnosis and mean pretreatment glucose level were predictors of the need for supplemental insulin therapy in women initially treated with metformin AIM The aim of this study was to assess the efficacy of glyburide in the treatment of gestational diabetes mellitus and to compare the maternal and fetal outcome between two groups treated either with insulin or glyburide . MATERIAL AND METHODS Women with gestational diabetes not responding to diet control were r and omized into two groups : ( i ) the control group receiving insulin ( n = 32 ) ; and ( ii ) the study group receiving glyburide ( n = 32 ) . Primary outcome was assessed in terms of achievement of glycemic control and secondary outcome was assessed by the incidence of maternal and fetal complications in the insulin and glyburide treated groups . RESULTS The achievement of glycemic control between the insulin and the glyburide treated groups showed no significant difference ( 97.1 % , 93.8 % ) . The occurrence of maternal complications ( P = 0.87 ) and fetal complications ( P = 0.32 ) were comparable between the insulin and glyburide treated groups . CONCLUSION Glyburide was found to be as efficacious as insulin in achieving euglycemia in the treatment of gestational diabetic women who require treatment beyond diet control
OBJECTIVE To investigate the effectiveness of different treatments for gestational diabetes mellitus ( GDM ) .