Accepted Manuscript Screening and management of gestational diabetes Katrien Benhalima, Roland Devlieger, André Van Assche

PII:

S1521-6934(14)00208-9

DOI:

10.1016/j.bpobgyn.2014.07.026

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YBEOG 1430

To appear in:

Best Practice & Research Clinical Obstetrics & Gynaecology

Received Date: 18 July 2014 Accepted Date: 23 July 2014

Please cite this article as: Benhalima K, Devlieger R, Van Assche A, Screening and management of gestational diabetes, Best Practice & Research Clinical Obstetrics & Gynaecology (2014), doi: 10.1016/ j.bpobgyn.2014.07.026. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT

Screening and management of gestational diabetes

Katrien Benhalima¹, Roland Devlieger², André Van Assche²

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¹Department of Endocrinology, UZ Gasthuisberg, KU Leuven, Herestraat 49, 3000 Leuven, Belgium

²Department of Obstetrics & Gynecology, UZ Gasthuisberg, KU Leuven, Herestraat 49, 3000

Address of correspondence:

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Leuven, Belgium

Dr. K Benhalima, Department of Endocrinology, UZ Gasthuisberg, Herestraat 49, 3000

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Leuven, Belgium; +3216340614; [email protected]

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Conflict of Interest statement: The authors have no conflict of interest concerning this article. No financial support was given for this article.

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Abstract Gestational diabetes (GDM) is a frequent medical condition during pregnancy. It is

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associated with an increased risk of complications for both the mother and the baby during pregnancy and post-partum. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) has proposed a new screening strategy for overt diabetes in pregnancy

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and screening for GDM. However, there still is lack of international uniformity in the

approach to screening and diagnosis of GDM. Controversies include universal versus

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selective screening, the optimal time for screening, appropriate tests and cut-off values, and whether testing should be done in one or two steps. This review gives an update on screening for GDM and overt diabetes during pregnancy. We also give an overview on the

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medical and obstetrical management of GDM.

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Key words: gestational diabetes, screening, management, overt diabetes

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A. Gestational diabetes as a health problem now and later Gestational diabetes (GDM) is a frequent medical condition during pregnancy and was historically defined as ‘any degree of glucose intolerance with onset or first recognition

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during pregnancy’ [1]. GDM has long been known to raise the risk of a large for gestational age (LGA) fetus, since the maternal glucose crosses the placenta and stimulates fetal insulin secretion which acts as a growth factor. LGA increases risks of macrosomia, shoulder

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dystocia and caesarian deliveries. GDM is also associated with pregnancy-induced

hypertension, pre-eclampsia and polyhydramnion. Short-term risks for the baby include

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neonatal hypoglycemia, hyperbilirubinemia, hypocalcemia, respiratory distress syndrome and polycythemia [2,3]. Shortly after delivery the glucose values are generally restored to normal, but women with GDM have a seven-fold increased risk of developing type 2 diabetes (T2DM) after pregnancy [4]. A history of GDM is also a marker for raised

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cardiovascular risk and early atherosclerosis [5].

Studies show that offspring exposed to maternal hyperglycemia are at increased risk of

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childhood overweight and have impaired pancreatic beta-cell function as adults [6-7]. In contrast, a systematic review showed that when adjusted for maternal obesity the

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associations between GDM and childhood overweight were not significant anymore [8]. Recent findings suggest that GDM has effects on DNA methylation of genes involved in energy metabolism, anti-inflammatory processes and insulin resistance which could partially explain the increased risk for cardio-metabolic morbidities later in life [9-10]. When the baby is female, exposure to maternal hyperglycemia in utero might increase her own risk of subsequently developing GDM in her own pregnancies. Compelling evidence for the role of epigenetic transmission has come from comparison of siblings born before and after the

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ACCEPTED MANUSCRIPT development of maternal diabetes, exposure to this intrauterine diabetic environment being shown to cause alterations in fetal growth patterns [11]. This metabolic programming by in utero exposure to hyperglycemia might therefore be a transgenerational effect contributing

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to the expected huge increase in prevalence of T2DM worldwide [12].

B. Screening for GDM

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Lack of uniformity in the guidelines for screening for GDM

Since long there is lack of international uniformity in the approach to screening and

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diagnosis of GDM. Controversies include universal versus selective screening, the optimal time for screening, appropriate tests and cut-off values, and whether testing should be done in one or two steps. Various large surveys completed by responders from many different countries, highlighted the strong variability that exists internationally in screening, diagnosis

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and management of women with GDM [13-14]. The initial criteria for diagnosis of GDM were established nearly 50 years ago [15]. These

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criteria were chosen to identify women at high risk for the development of diabetes after pregnancy and not to identify pregnancies with increased risk for adverse perinatal outcome

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[16]. Progressively more data have shown that the risk of adverse perinatal outcomes is also associated with degrees of hyperglycemia less severe than overt diabetes during pregnancy. The HAPO study showed a continuous and graded relationship between the maternal hyperglycemia and the risk for an adverse perinatal outcome, independent of other risk factors [2]. After reviewing the results of the HAPO study, the ‘International Association of Diabetes and Pregnancy Study Groups’ (IADPSG) developed a new consensus that recommends screening for overt diabetes early in pregnancy and for an universal screening 4

ACCEPTED MANUSCRIPT with the 2-hour 75-g oral glucose tolerance test (OGTT) from 24-28 weeks of gestation using more stringent diagnostic criteria for GDM [17]. Furthermore one abnormal value is now enough for the diagnosis of GDM [Table 1]. These criteria are the first diagnostic criteria for

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GDM based on perinatal outcome and therefore unique. Internationally, the IADPSG recommendation for screening for GDM remains controversial since in most populations this will lead to a significant increase in the number of women

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labeled and treated as GDM [18,19]. Other raised comments are the paucity of data on the cost effectiveness of such screening strategy, the uncertainty on the clinical relevance of

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treatment of mild GDM based on the IADPSG criteria and the uncertainty on the risk of women who have had mild GDM to develop T2DM post-partum [20-22]. While the American Diabetes Association (ADA) has since December 2010 adopted the IADPSG recommendations, the American College of Obstetricians and Gynecologists (ACOG)

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and an independent expert panel assigned by the National Institute of Health (NIH) continue to promote to use of the two-step screening strategy with the non-fasting 50g glucose

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challenge test (GCT) and if abnormal followed by the 3-hour 100g OGTT using the Carpenter & Coustan criteria or the National Diabetes Data Group criteria [23,24] [Table 1]. Recently

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both the World Health Organization (WHO) and the Endocrine Society revised their guidelines and now advise the use of the IADPSG criteria for the diagnosis of GDM [25,26]. The latest 2014 ADA recommendations, specify that further research is needed to establish a uniform approach to diagnosing GDM and leave now open the option between the one-step IADPSG recommendation or the two-step screening strategy [27] [Table 2]. Meanwhile the European Board and College of Obstetrics and Gynecology (EBCOG) has appointed a steering committee, including members of EBCOG and representatives of the

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ACCEPTED MANUSCRIPT Diabetic Pregnancy Study Group, to prepare a proposal for the use of uniform diagnostic criteria for GDM in Europe. The proposal is currently under review by the national societies [presentation at the EBCOG conference in May 2014 by Benhalima K].

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Screening for overt diabetes and GDM in early pregnancy Women with unknown overt diabetes in pregnancy are at increased risk for congenital anomalies due to their greater degree of hyperglycemia earlier in pregnancy [29]. Since the

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frequency of obesity and T2DM in young adults is increasing worldwide and since the use of

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a simple screening test will lead to more women being timely diagnosed with overt diabetes, most guidelines recommend now screening for overt diabetes at first prenatal visit, especially in high risk groups [17, 25-27]. Cut-offs for tests used to detect diabetes in the non-pregnant population are recommended in early pregnancy [fasting plasma glucose ≥

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126mg/dl (7.0mmol/l), random plasma glucose ≥ 200 mg/dl (11.1mmol/l) or HbA1c ≥ 6.5% (47mmol/mol)]. The WHO however does not consider HbA1c for the diagnosis of overt diabetes [25].

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It is generally considered that there is not enough evidence to recommend screening and

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treatment of GDM before 24 weeks of gestation [27,29]. However, the IADPSG recommends that a FPG ≥ 92mg/dl (5.1mmol/l) in early pregnancy be classified as GDM [17]. This is now also endorsed by the WHO and the Endocrine Society [25,26] but remains very debated as this recommendation was merely based on data extrapolated from the cut-off value used on the 75g OGTT later in pregnancy. A recent evaluation of the FPG in the first prenatal visit to diagnose GDM in China showed that a FPG between 110-125 mg/dl (6.1-6.9mmol/l) was a much better predictor of the development of GDM and that for their population, a FPG ≥ 92

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ACCEPTED MANUSCRIPT mg/dl (5.1mmol/l) at first prenatal visit could not be supported as the criterion for diagnosis of GDM [30].

The value of the 50g glucose challenge test to screen for GDM

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The GCT has the advantage that it can be performed throughout the day without the need to be in fasting conditions. A systematic review showed that for universal screening the

sensitivity of the GCT was 0.74 for a specificity of 0.85 [31]. A recent study comparing a FPG

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and GCT for screening for GDM, showed an overall sensitivity and specificity for the GCT of

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75.0% and 92.0% and for the FPG resp. 88.8% and 95.2% [32]. A recent study showed that among women with a positive GCT, those tested in the afternoon have better metabolic function and a lower risk of GDM on subsequent OGTT [33]. This suggest that the time of day of testing may lead to misclassification of patients with markedly elevated GCT results when a threshold is applied at which GDM can be diagnosed without proceeding to the OGTT. All

replace the OGTT.

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together, these findings show that the GCT is acceptable to screen for GDM, but cannot

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The value of HbA1c to screen for GDM

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A recent study showed that women with a HbA1c of 5.7-6.4% (39-46 mmol/mol) in early pregnancy had a threefold increased risk of progression to GDM compared to women with a normal Hba1c [354]. A study in India showed that by using different ranges of Hba1c for the IADPSG criteria and the old ADA criteria, an OGTT could be avoided in approximately 40% (IADPSG) and 60% (ADA) of women [35]. Recent data from a New-Zealand population show that pregnant women with a normal OGTT but Hba1c > 5.8% (40mmol/mol) are likely to require pharmacotherapy [36]. However, the HAPO study showed that associations with

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ACCEPTED MANUSCRIPT adverse outcomes were significantly stronger with glucose measures than with Hba1c [37]. All together, these findings suggest that a Hba1c measurement is not a useful alternative to an OGTT in pregnant women. Additionally, Hba1c is not reimbursed for screening in many

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countries.

Selective screening versus universal screening for GDM

Recent studies confirm that selective screening would lead to missing one-third of women

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with GDM, who even without risk factors, had more events than women without GDM and

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this was irrespective of ethnicity [38,39]. Applying selective screening guidelines for GDM to a large pregnant cohort from Ireland, showed that the ADA guidelines would result in the lowest number of missed cases compared to the Irish and the National Institute for Health and Clinical Excellence guidelines [40]. On the other hand, several studies have shown that a

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two-step screening algorithm including a FPG measurement and a risk estimation model, can increase sensitivity >90% for predicting GDM [41,42]. In 2008 The U.S. Preventive Services Task Force Recommendation (USPSTF) concluded that the evidence was insufficient to

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assess balance of benefits and harms of screening for GDM before or after 24 weeks of gestation [43]. In the update of 2014, USPSTF now recommends screening for GDM in

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asymptomatic pregnant women after 24 weeks of gestation [29]. This change in recommendation is based on evidence from several systematic reviews showing that a GCT and a FPG are good at identifying women who do not have GDM and that the diagnostic criteria used for GDM identify pregnancies at increased risk of adverse feto-maternal outcomes [44,45].

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The impact of the IADPSG criteria on pregnancy outcomes Data on the impact of implementing the IADPSG criteria are currently based on retrospective

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analysis comparing the two-step screening strategy or the former WHO screening strategy with the IADPSG criteria. Several studies show that women classified as normal glucose tolerant (NGT) but considered GDM according to the IADPSG criteria, have impaired

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pregnancy outcomes compared to NGT women while some studies show similar pregnancy

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outcomes as NGT women [46-49]. Analyses of the Israeli HAPO study, showed that screening with FPG and BMI may be a practical alternative as this detected proportions of adverse outcomes similar to IADPSG criteria [50]. Moreover, one-third of IADPSG-positive women were at low risk for adverse outcomes and could be managed less intensively. A

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systematic review showed that associations with pregnancy outcomes were of similar magnitude for the IADPSG criteria and the WHO criteria but a high inconsistency was seen for those with the IADPSG criteria [51]. A recent systematic review assessing different

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diagnostic thresholds for GDM on outcomes, showed that higher glucose thresholds did not

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consistently demonstrate greater risk, possibly because studies did not compare mutually exclusive groups of women [52]. The IADPSG recommendations are in the present form not simple enough to implement in low resource settings. Options need to be offered that can be used in different settings such as measuring FPG alone to either diagnose or screen for GDM, using non-fasting glucose testing or using a GCT [53].

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ACCEPTED MANUSCRIPT Thus far, two studies have addressed the cost-effectiveness of GDM screening according to the IADPSG criteria using decision analysis models for a US population [54,55]. One study showed that the IADPSG recommendations are cost effective only when post-delivery care reduces diabetes incidence [54]. In the second study, treatment according to IADPSG would

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be cost-effective if treatment would result in decreased preeclampsia >0.55% and decreased cesarean delivery >2.7% [55]. It is however highly doubtful to assume that treatment of GDM would lead to a decreased cesarean delivery rate in routine care since intervention

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RCTs have been conflicting and recent analyses showed that women with GDM had

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significantly higher levels of cesarean deliveries and neonatal unit admissions, leading to a 34% higher cost of care compared to women without GDM [56]. Analyses from the United Arab Emirates, showed that switching from a two-step to a one-step strategy would increase cost by 42% but decrease the laboratory workload by 36% [57]. For their population an initial

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screen by FPG would avoid about 50% of OGTTs and would therefore be the ideal strategy, both in terms of cost and workload.

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Post-partum screening for glucose intolerance The best postpartum screening strategy for glucose intolerance among women with a

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history of GDM is also still debated. The ADA and the Endocrine Society recommend to screen women with a history of GDM at 6-12 weeks postpartum using the 2-h 75g OGTT with non-pregnancy diagnostic criteria [26,27]. It is acknowledged that this recommendation is mostly based on expert consensus or clinical experience. Studies evaluating the use of HbA1c alone or in combination with FPG to diagnose glucose intolerance in women who have had GDM, show conflicting results with sensitivity rates of HbA1c and FPG combined ranging

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ACCEPTED MANUSCRIPT from 83.0% to 90.0% [58,59]. Measurement of Hba1c alone does not seem to perform properly in this setting [59]. Women with a history of GDM should have lifelong screening for the development of

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glucose intolerance, at least every 3 years [27]. Currently there is insufficient evidence to recommend one test over the other and therefore HbA1C, FPG, or 75-g 2-h OGTT are

appropriate to test for glucose intolerance. Women with a history of GDM, found to have

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prediabetes should receive lifestyle interventions with or without metformin since this has

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been shown to delay or prevent diabetes in >50% of women [60].

C. Medical management of GDM

The importance of treatment of GDM

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Two large randomized intervention trials have demonstrated improvement in perinatal outcomes in the group of women who received treatment of mild glucose intolerance during pregnancy, especially in the frequency of LGA and preeclampsia [61,62]. A recent meta-

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analysis confirms that treating GDM results in less preeclampsia, schoulder dystocia and macrosomia but current evidence does not show an effect on neonatal hypoglycemia or

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future poor metabolic outcomes [63].

Lifestyle interventions

Initial treatment of GDM involves diet modification, glucose monitoring and moderate exercise [26,27]. If lifestyle is insufficient to maintain the glycemic targets after 1-2 weeks, pharmacological therapy becomes necessary. There is a paucity of evidence-based data concerning nutritional treatment but the general recommendations are to follow the

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ACCEPTED MANUSCRIPT Institute of Medicine revised guidelines for weight gain during pregnancy, to reduce the calorie intake of obese women by approximately one-third while maintaining a minimum intake of 1600-1800 kcal/d, to limit the carbohydrate intake tot 35-45% of total calories and to perform daily moderate exercise for 30 minutes or more [26,27,64]. Table 3 gives an

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overview of the general recommended glycemic targets [26,27]. Based on a recent metaanalysis showing a lower risk of macrosomia with a lower FPG, the Endocrine Society

suggests now a FPG target of ≤90mg/dl (5.0mmol/l) if this can be safely achieved without

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Pharmacotherapy

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undue hypoglycemia [26,65].

Insulin has been the treatment of choice when lifestyle measures do not maintain glycemic control during pregnancy. The long acting insulin NPH and detemir and the short acting

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insulin human regular and the insulin analogs lispro and aspart are approved for use in pregnancy [26,27, 66]. The long acting insulin analog glargine is now generally considered to be safe for use in pregnancy but due of lack of data from RCT’s, this is not yet officially

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approved for use during pregnancy [26, 67]. Compared to human regular, lispro and aspart allow greater lifestyle flexibility, greater patient satisfaction and may also provide better

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postprandial blood glucose control and Hba1c reduction [68]. Rapid-acting insulin analogs are therefore recommend in preference to regular insulin [26,27]. Recent studies have suggested that metformin and glibenclamide (glyburide) may be safe and acceptable alternatives. Several studies have shown that there is no increase in congenital anomalies with metformin, despite it crossing the placenta [69]. Studies of the use of metformin in GDM show equivalent pregnancy outcomes, while reporting reduction in weight gain and less maternal hypoglycemia [69]. However, the need for supplemental 12

ACCEPTED MANUSCRIPT insulin in the metformin group was 46.3% in the MIG trial [70]. A recent meta-analysis of glibenclamide shows that compared to insulin, the risks for neonatal hypoglycemia and macrosomia are higher [71]. Moreover there is a paucity of long-term follow data on children exposed to oral agents in utero. The ADA therefore only recommends insulin as

also be used to treat GDM [27,72].

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D. Obstetrical management of GDM.

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pharmacotherapy for GDM while ACOG recommends that metformin or glibenclamide can

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Obstetrical management concentrates on fetal surveillance, evaluation of fetal growth, timing and mode of delivery and care during labour and postpartum.

Fetal surveillance

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There is an increased risk for intrauterine death in overt diabetes, but also in GDM (73). ACOG has stated that women with GDM not under perfect control, receiving insulin or with other risk factors such as hypertension or an adverse obstetrical history should be managed

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in the same way as pregnant women with prepregnancy diabetes. It is recommended to use the non stress test, the contraction stress test or the biophysical profile. But also in

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uncomplicated GDM pregnancies fetal surveillance is recommended (74).

Fetal growth

An increased transplacental transfer of glucose and other nutrients is present in the diabetic pregnancy, inducing hyperplasia of the insulin producing fetal B cells and as a consequence fetal hyperinsulinism (75, 76). Increased nutrient transfer and increased fetal insulin activity explain the occurrence of (asymmetric) macrosomia, characterised by broader shoulders

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ACCEPTED MANUSCRIPT compared to the head, a shorter neck and increased thoracic and abdominal diameters, explaining the higher rate of shoulder dystocia (77). Regular ultrasound evaluation provides information on fetal growth and fetal weight. However it should be clear that the prediction of fetal weight is not always accurate. The evaluation of fetal body composition rather than

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fetal body weight using ultrasound indices or MRI could be a more accurate predictor of neonatal adiposity (78).

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Timing and mode of delivery

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The timing and mode of delivery is inspired by the increased risk of stillbirth and the increased risk of shoulder dystocia. Early induction of labour is confronted with the problem of an unripe cervix. Moreover the neonate of a diabetic mother suffers more from prematurity than a neonate from a non-diabetic mother (79). Clear evidence for deciding on

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the time and mode of delivery is not available. Therefore recommendations may vary according with the interpretation of non randomized studies or based on expert opinions (73). ACOG states that early delivery may be indicated in some patients with complicated

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pregestational diabetes. It is also suggested to plan a caesarean delivery if the expected fetal weight is more than 4550 g (80). Regarding GDM, ACOG does not recommend to decide for

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induction or caesarean section. ACOG suggests to follow fetal growth and fetal surveillance in the third trimester, and also to plan a caesarean delivery if the fetal weight is expected to be more than 4500 g. The Royal College of Obstetricians and Gynaecologists (RCOG) suggests to consider elective caesarean section for pregnancies complicated by preexisting diabetes or GDM , regardless of treatment, if the expected fetal weight is more than 4500 g. Regarding the non-complicated GDM, the RCOG indicates that induction of labour at term may reduce the incidence of shoulder dystocia and stillbirth (81). This means that GDM as 14

ACCEPTED MANUSCRIPT such is not an indication for Caesarean section. However the incidence of Caesarean section overall is very high and it is certainly more common in GDM than in non diabetic pregnancies.

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Care during labor and postpartum During labour and delivery maternal euglycaemia should be maintained in order to avoid neonatal hypoglycaemia. After delivery insulin resistance disappears quickly and maternal

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glucose metabolism normalizes in GDM. Some women with GDM have undiagnosed overt

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diabetes, measurement of plasma glucose concentration the days after delivery is recommended (73). As stated previously women with GDM have an increased risk to

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become diabetic in later life, these women need therefore strict control.

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Summary Screening for overt diabetes at first prenatal visit is now generally recommended using the

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cut-offs for tests used to detect diabetes in the non-pregnant population. Treatment of mild glucose intolerance in pregnancy has been shown to reduce adverse perinatal outcomes. There is therefore now enough evidence to recommend universal screening for GDM after

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24 weeks of gestation. The IADPSG diagnostic criteria for GDM are the first diagnostic

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criteria for GDM based on perinatal outcome and therefore unique. Internationally, the IADPSG recommendation for screening and diagnosing GDM remains controversial since in most populations this will lead to a significant increase in the number of women labeled and treated as GDM. More data are therefore necessary on the cost effectiveness of the one-

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step IADPSG screening strategy for GDM. The IADPSG recommendations are in the present form also not simple enough to implement in low resource settings. Different options need to be evaluated that can be used in different settings. Initial treatment of GDM involves diet

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modification, glucose monitoring and moderate exercise. Insulin has been the treatment of choice when lifestyle measures do not maintain glycemic control during pregnancy. Women

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with a history of GDM should have lifelong screening for the development of glucose intolerance but more research is necessary on the best post-partum screening strategy. Fetal surveillance and the evaluation of fetal growth is important to avoid intra uterine death and shoulder dystocia.

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Table 1: An overview of the different diagnostic criteria for GDM

Carpenter & Coustan

IADPSG

3-hour 100g OGTT

3-hour 100g OGTT

2-hour 75g OGTT

fasting

≥105 (5.8)

≥95 (5.3)

1h

≥190 (10.6)

≥180 (10.0)

2h

≥165 (9.2)

≥155 (8.6)

3h

≥145 (8.0)

≥92 (5.1)

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≥180 (10.0)

≥153 (8.5)

≥140 (7.8)

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The number of abnormal values needed for the diagnosis of GDM

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NDDG

≥2

≥1

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Values are presented in mg/dl (mmol/l). NDDG: National Diabetes Data Group; OGTT: oral glucose tolerance test; IADPSG: The International Association of Diabetes and Pregnancy Study Groups

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Table 2: Overview of the different international recommendations for screening for GDM

 IADPSG criteria for GDM  One-step screening strategy with

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WHO Endocrine Society

IADPSG criteria Option between:  One-step screening strategy with IADPSG criteria OR  Two-step screening strategy with 50g GCT and 100g OGTT with the Carpenter & Coustan criteria or the NDDG criteria

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ADA

 Two-step screening strategy with 50g GCT and 100g OGTT with the Carpenter & Coustan criteria or the NDDG criteria

ACOG

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NIH

 Two-step screening strategy with 50g

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GCT and 100g OGTT with the Carpenter & Coustan criteria or the NDDG criteria WHO: World Health Organization; ADA: American Diabetes Association; NIH: National Institute of Health; ACOG: American College of Obstetricians and Gynecologists; IADPSG: The International Association of Diabetes and Pregnancy Study Groups; GCT: glucose challenge test; OGTT: oral glucose tolerance test; NDDG: National Diabetes Data Group

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Table 3: Glycemic targets during pregnancy for women with GDM

Target value mg/dl (mmol/l) ≤95 (5.3) ≤140 (7.8) ≤120 (6.7)

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Fasting blood glucose 1 hour after the start of a meal 2 hours after the start of a meal

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Practice Points •

Screening for overt diabetes at first prenatal visit is recommended especially in high risk groups using the cut-offs for tests used to detect diabetes in the non-pregnant



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population. There is now enough evidence to recommend universal screening for GDM after 24 weeks of gestation.

The IADPSG criteria for GDM are the first diagnostic criteria based on perinatal

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outcome.

Women with a history of GDM should have lifelong screening for the development of glucose intolerance.



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The fetus and the neonate of mothers with GDM are at risk. The evaluation of fetal

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surveillance and fetal growth should be performed.

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Research Agenda •

More evidence is needed on which women would benefit most from screening of



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GDM in early pregnancy and on which screening strategy for GDM should be used. More data are needed on the cost-effectiveness of a universal one-step screening strategy with the 75g OGTT using the new IADPSG diagnostic criteria for GDM.

More data are necessary on the best post-partum screening strategy for glucose

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intolerance among women with a history of GDM.

More research is necessary on the prevention of GDM and risk reduction post-

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partum for women and offspring for the development of cardio-metabolic morbidities. •

More scientific information is necessary on the time and mode of delivery in GDM

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pregnancies.

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International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care 2007;30(suppl 2):S251-S260. 17. *International Association of Diabetes and Pregnancy Study Groups Consensus Panel. International association of diabetes and pregnancy study groups recommendations on the diagnostic and classification of hyperglycemia in pregnancy. Diabetes Care 2010;33:676-682.

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ACCEPTED MANUSCRIPT 18. Jenum AK, Mǿrkrid K, Sletner L et al. Impact of ethnicity on gestational diabetes identified with the WHO and the modified IADPSG criteria: a population-based cohort study. Eur J Endocrinol 2012,166:317-324. 19. Liao S, Mei J, Song W et al. The impact of the International Association of Diabetes and

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Pregnancy Study Groups (IADPSG) fasting glucose criterion on the prevalence and outcomes of gestational diabetes mellitus in Han Chinese women. Diabet Med 2014;31:341-351.

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20. Ryan EA. Diagnosing gestational diabetes. Diabetologia 2011;DOI 10.1007/s00125-010-

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2005-4.

21. Waugh N, Pearson D, Royle P. Screening for hyperglycaemia in pregnancy: consensus and controversy. Best Practice & Research Clinical Endocrinology & Metabolism 2010,24:553571.

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22. *Cundy T, Ackermann E, Ryan EA. Gestational diabetes: new criteria may triple the prevalence but effect on outcomes is unclear. BMJ 2014,11;348:g1567. doi: 10.1136/bmj.g1567.

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23. Committee on Obstetric Practice Screening and diagnosis of gestational diabetes

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mellitus. Obstetrics & Gynecology 2011; 118:751-753. 24. Vandorsten JP, Dodson WC, Espeland MA et al. NIH Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus. NIH Consensus State Sci Statements 2013,29:1-31.

25. The World Health Organization guideline 2013. Diagnostic criteria and classification of hyperglycaemiafirstdetectedinpregnancy.http://apps.who.int/iris/bitstream/10665/8597 5/1/WHO_NMH_MND_13.2_eng.pdf. Accessed on 17-11-2013.

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ACCEPTED MANUSCRIPT 26. Blumer I, Hadar E, Hadden DR et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. JCEM 2013;98:4227-4249. 27. American Diabetes Association. Standards of Medical Care in diabetes-2014. Diabetes Care 2014;37:S14-S80.

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28. Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care 2008;31:899-904.

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29. Preventive Services Task Force. Screening for gestational diabetes mellitus: U.S

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Preventive Services Rask Force recommendation statement. Ann Intern Med 2014;160:414-420.

30. *Zhu W-W, Yang H-X, Wei Y-M et al. Evaluation of the value of fasting plasma glucose in first prenatal visit to diagnose gestational diabetes mellitus in China. Diabetes Care

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2013;36:586-590.

31. van Leeuwen M, Louwerse MD, Opmeer BC et al. Glucose challenge test for detecting gestational diabetes mellitus: a systematic review. BJOG 2012;119:393-401.

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32. Poomala GK, Rangaswamy V. A comparison of fasting plasma glucose and glucose

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challenge test for screening of gestational diabetes mellitus. J Obstet Gynaecol 2013;33:447-450.

33. Goldberg RJ, Ye C, Sermer M et al. Circadian variation in the response to the glucose challenge test in pregnancy. Diabetes Care 2012;35:1578-1584. 34. Raiput R, Yadav Y, Raiput M, Nanda S. Utility of Hba1c for diagnosis of gestational diabetes mellitus. Diabetes Res Clin Pract 2012;98:104-107. 35. Fong A, Serra AE, Gabby L et al. Use of hemoglobin A1c as an early predictor of gestational diabetes. Am J Obstet Gynecol 2014;pii:S0002-93789(14)00577-8. 25

ACCEPTED MANUSCRIPT 36. Rowan JA, Budeen A, Sadler LC. Women with a nondiagnostic 75g glucose tolerance test but elevated HbA1c in pregnancy: An additional group of women with gestational diabetes. ANZJOG 2014;54:177-180.

(HAPO) study. Diabetes Care 2012;35:574-580.

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37. Lowe P, Metzger BE, Dyer AR et al. Hyperglycaemia and adverse pregnancy outcome

38. Cosson E, Benbara A, Pharisien I et al. Diagnostic and prognostic preformances over 9

18,775 subjects. Diabetes Care 2013;36:598-603.

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years of a selective screening strategy for gestational diabetes mellitus in a cohort of

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39. Cosson E, Cussac-Pillegand C, Benbara A t al. The diagnostic and prognostic performance of a selective screening strategy for gestational diabetes mellitus according to ethnicity in Europe. JCEM 2014;99:996-1005.

40. Avalos GE, Owens LA, Dunne F. Applying current screening tools for gestational diabetes

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mellitus to a European population: Is it time to change? Diabetes Care 2013;36:30403044.

41. Göbl CS, Bozkurt L, Rivic et al. A two-step screening algorithm including fasting plasma

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glucose measurement and a risk estimation model is an accurate strategy for detecting

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gestational diabetes mellitus. Diabetologia 2012;55:3173-3181. 42. Savona-Ventura C, Vassallo J, Marre M and Karamanos BG for the MGSD-GDM study group. A composite risk assessment model to screen for gestational diabetes mellitus among Mediterranean women. International Journal of Gynecology and Obstetrics 2013;120:240-244. 43. U.S. Preventive Services Task Force. Screening for gestational diabetes mellitus: U.S Preventive Services Rask Force recommendation statement. Ann Intern Med 2008;148:759-765. 26

ACCEPTED MANUSCRIPT 44. *Donovan L, Hartling L, Muise M et al. Screening tests for gestational diabetes: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med 2013;159:115-122. 45. Prutsky GJ, Domecq JP, Sundaresh V et al. Screening for gestational diabetes: a

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systematic review and meta-analysis. JCEM 2013;98:4311-4318.

46. Benhalima K, Hanssens M, Devlieger R et al. Analysis of pregnancy outcomes using the new IADPSG recommendation compared with the Carpenter and Coustan criteria in an

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area with a low prevalence of gestational diabetes. Int J Endocrinology 2013,

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doi.org/10.1155/2013/248.121.

47. Hirst JE, Tran TS, Do MA et al. Consequences of gestational diabetes in an urban hospital in Viet Nam: a prospective cohort study. Plos Med 2012; 9(7):e1001272. Doi:10.1371/journal.pmed.1001272.

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48. Reyes-Muῆez E, Parra A, Castillo-Mora A , Ortega-Gonzales C. Effect of the International Association of Diabetes and Pregnancy Study Groups diagnostic criteria on the prevalence of gestational diabetes in urban Mexican women: a cross-sectional study.

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Endocr Pract. 2012;18:146-151.

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49. Bodmer-Roy S, Morin L, Cousineau J, Rey E. Pregnancy outcomes in women with and without diabetes mellitus according to the international association of the diabetes in pregnancy study groups criteria. Obstet Gynecol 2012;120:746-752. 50. *Kalter-Leibovici O, Freedman LS, Olmer L et al. Screening and diagnosis of gestational diabetes mellitus. Critical appraisal of the new International Association of Diabetes in Pregnancy Study Group recommendations on a national level. Diabetes Care 2012;35:1894-1896.

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ACCEPTED MANUSCRIPT 51. Wendland EM, Torloni MR, Falavigna M, et al. Gestational diabetes and pregnancy outcomes-a systematic review of the World Health Organization (WHO) and the new International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria. BMC Pregnancy and Childbirth 2012;12:23 (1-13).

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52. Hartling L, Dryden DM, Guthrie A et al. Diagnostic thresholds for gestational diabetes and their impact on pregnancy outcomes: a systematic review. Diabet Med 2014;31:319-331. 53. Colagiuri S, Falavigna M, Agarwal MM et al. Strategies for implementing the WHO

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Diabetes Res Clin Pract 2014;103:364-372.

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diagnostic criteria and classification of hyperglycemia first detected in pregnancy.

54. *Werner EF, Petther CM, Zuckerwise L et al. Screening for gestational diabetes mellitus: are the criteria proposed by the International Association of Diabetes and Pregnancy Study Groups cost-effective? Diabetes Care 2012; 35:529-535.

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55. Mission JF, Ohno MS, Cheng YW, Caughey AB. Gestational diabetes screening with new IADPSG guidelines: a cost-effectiveness analysis. Am J Obstet Gynecol 2012;207:326e1-9. 56. Gillespie P, Culligan J, O’Neill C, Dunne F. Modeling the independent effects of

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1116.

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gestational diabetes mellitus on maternity care and costs. Diabetes Care 2013;36:1111-

57. Agarwal MM, Dhatt GS , Othman Y. Gestational diabetes in a tertiary care hospital: implications of applying the IADPSG criteria. Arch Gynecol Obstet 2012;286:373-378. 58. E. Noctor, C. Crowe, L. A. Carmody LA et al. ATLANTIC DIP: simplifying the follow-up of women with previous gestational diabetes. Eur J Endocrinol 2013; 169, 681-687. 59. Picón MJ, Murri M, Muñoz A et al. Hemoglobin A1c versus oral glucose tolerance test in postpartum diabetes screening. Diabetes Care 2012; 35:1648-53.

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ACCEPTED MANUSCRIPT 60. Diabetes Prevention Program Research Group. Reduction in the incidence of type, 2 diabetes with lifestyle intervention or metformin. N Engl J of Med 2002; 346: 393-403. 61. Crowther CA, Hiller JE, Moss JR et al. Australian Carbohydrate Intolerance study in Pregnancy Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes

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62. Landon MB, Spong CY, Thom E et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med 2009; 361:1339-1348.

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63. Hartling L, Dryden DM, Guthrie A et al. Benefits and harms of treating gestational

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diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the national Institutes of health office of medical applications of research. Ann Intern Med 2013;159:123-129.

64. Institute of Medicine (US) and National Research Council (US) Committee to Reexamine

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IOM Pregnancy Weight Guidelines. Weight Gain During Pregnancy: Reexamining the Guidelines. Rasmussen KM & Yaktine AL (eds). The National Academies Collection: Reports funded by National Institutes of Health. The National Academies Press,

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65. Prutsky GJ, Domecq JP, Wang Z et al. Glucose targets in pregnant women with diabetes: a systematic review and meta-analysis. JCEM 2013;98:4319-4324. 66. Mathiesen ER, Hod M, Ivanisevic M et al. Maternal efficacy and safety outcomes i a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care 2012;35:2012-2017. 67. Price N, Bartlett C, Gillmer M. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG 2007;114:453-457.

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ACCEPTED MANUSCRIPT 68. Durnwald CP, Landon MB. A comparison of lispro and regular insulin for the management of type 1 and type 2 diabetes in pregnancy. J Matern Fetal neonatal Med 2008;21:309-313.

meta-analysis. Plos One 2013;8:e64585-e64585.

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69. Gui J, Liu Q, Feng L. Metformin vs insulin in the management of gestational diabetes: a

70. Rowan JA, Hague WM, Gao W et al. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med 2008;358:2003-2015.

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71. Zeng YC, Li MJ, Chen Y et al. The use of glyburide in the management of gestational

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diabetes mellitus: a meta-analysis. Adv Med Sci 2014;59:95-101.

72. Committee on Practice Bulletins-Obstetrics, The American College of Obstetrics and Gynecologists. Practice bulletin no. 137: gestational diabetes mellitus. Obstet Gynecol 2013;122:406-416.

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73. Coustan DR. Gestational diabetes mellitus. Clin Chem2013;59:1310-1321. 74. ACOG committee on Practice Bulletins- Obstetrics. Gestational diabetes. Obstet Gynecol 2001; 98: 525-538.

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75. Van Assche F A, Gepts W. The cytological composition of the foetal endocrine pancreas

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in normal and pathological conditions. Diabetologia 1971;50:2279-2286. 76. Galjaard S, Devlieger R, Van Assche F A. Fetal growth and developmental programming .J Perinat Med 2013; 41: 101-105. 77. Van Assche F A. Symmetric and asymmetric macrosomia. Am j Obstet Gynecol 1997; 177: 1563- 1564. 78. O'Connor C, Doolan A, O'Higgins A, Segurado R, Sheridan-Pereiraet M, Turner MJ, Stuart B, Kennelly MM. Fetal subcutaneous tissue measurements in pregnancy as a predictor of

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ACCEPTED MANUSCRIPT neonatal total body composition. Prenat Diagn. 2014 May 1. doi: 10.1002/pd.4400. [Epub ahead of print]. 79. *Maso G, Piccoli M, Parolin S et al. Diabetes in pregnancy : Timing and mode of delivery. Curr Diab Rep 2014; 14: 506.

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80. ACOG Committee on Practice Bulletins. Gestational diabetes 2013 mellitus. Obstet Gynecol 2013; 122: 406-416.

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Guideline No. 42 London : RCOG press ; 2012.

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81. Royal College of Obstetricians and Gynaecologists . Shoulder Dystocia. Green- Top

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ACCEPTED MANUSCRIPT

Summary Screening for overt diabetes at first prenatal visit is now generally recommended using the

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cut-offs for tests used to detect diabetes in the non-pregnant population. Treatment of mild glucose intolerance in pregnancy has been shown to reduce adverse perinatal outcomes. There is therefore now enough evidence to recommend universal screening for GDM after

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24 weeks of gestation. The IADPSG diagnostic criteria for GDM are the first diagnostic

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criteria for GDM based on perinatal outcome and therefore unique. Internationally, the IADPSG recommendation for screening and diagnosing GDM remains controversial since in most populations this will lead to a significant increase in the number of women labeled and treated as GDM. More data are therefore necessary on the cost effectiveness of the one-

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step IADPSG screening strategy for GDM. The IADPSG recommendations are in the present form also not simple enough to implement in low resource settings. Different options need to be evaluated that can be used in different settings. Initial treatment of GDM involves diet

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modification, glucose monitoring and moderate exercise. Insulin has been the treatment of choice when lifestyle measures do not maintain glycemic control during pregnancy. Women

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with a history of GDM should have lifelong screening for the development of glucose intolerance but more research is necessary on the best post-partum screening strategy. Fetal surveillance and the evaluation of fetal growth is important to avoid intra uterine death and shoulder dystocia.

Screening and management of gestational diabetes.

Gestational diabetes (GDM) is a frequent medical condition during pregnancy. It is associated with an increased risk of complications for both the mot...
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