Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study: a protocol for a prospective, longitudinal cohort study.

A diagnosis of gestational diabetes mellitus (GDM) in low-risk pregnant women is based on an oral glucose tolerance test (OGTT) between 24 and 28 gestational weeks. However, there is insufficient evidence for why the test is performed in this time period. Moreover, the fetus may be exposed to hyperglycaemia prior to the current testing time frame, making earlier administration potentially advantageous. The main purpose of the present study is to investigate the GDM diagnostic value of an OGTT performed at 18-20 gestational weeks. The results of the study may provide scientific insight into the most beneficial time of OGTT for pregnant women. As a prospective, longitudinal cohort study, the Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study will recruit 570 pregnant women who meet the inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early OGTT) and 24-28 gestational weeks (regular OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis. The prevalence of GDM at 18-20 gestational weeks will be described, and the sensitivity, specificity, positive predictive value and negative predictive value of early OGTT on diagnosis of GDM will be studied. Clinical outcomes associated with hyperglycaemia will be compared between groups diagnosed by early or regular OGTT. The study was approved by The Ethical Committees of The First Affiliated Hospital of Sun Yat-sen University (number 2016-042). Signed informed consent will be obtained from all participants. The results of this study will be disseminated in peer-reviewed journals. NCT02740283.

Liu B ，Xu Y ，Zhang Y ，Cai J ，Deng L ，Yang J ，Zhou Y ，Long Y ，Zhang J ，Wang Z ... -  《BMJ Open》

Early Diagnosed Gestational Diabetes Mellitus Is Associated With Adverse Pregnancy Outcomes: A Prospective Cohort Study.

The significance of an early diagnosis of gestational diabetes mellitus (GDM) with oral glucose tolerance test (OGTT) has not been determined. The objective of this work is to investigate GDM diagnosed by early and standard OGTTs and determine adverse maternal and neonatal outcomes associated with early GDM diagnosis. The Early Diagnosis of Gestational Diabetes Mellitus study is a prospective cohort study. Each participant in the study underwent 2 OGTTs, an early OGTT at 18 to 20 gestational weeks (gws) and a standard OGTT at 24 to 28 gws. The reproduciblity between early and standard OGTT were analyzed. Maternal and neonatal metabolic disorders and pregnancy outcomes were compared across groups. A total of 522 participants completed both the early and standard OGTTs. The glucose values in the early OGTT were not significantly different from those in the standard OGTT (fasting: 4.31 ± 0.41 mmol/L vs 4.29 ± 0.37 mmol/L, P = .360; 1-hour: 7.68 ± 1.71 mmol/L vs 7.66 ± 1.59 mmol/L, P = .826; 2-hour: 6.69 ± 1.47 mmol/L vs 6.71 ± 1.39 mmol/L, P = .800). The reproducibility of early and standard OGTT results was 74.9%. Pregnant women in the GDM group had higher glycated hemoglobin, C-peptide, and homeostasis model assessment of insulin resistance in the late gestational period. Neonates born to mothers in the GDM group were at a higher risk of being large for gestational age (odds ratio [OR]: 3.665; 95% CI, 1.006-11.91) and were also more prone to neonatal hyperinsulinemia (OR: 3.652; 95% CI, 1.152-10.533). Early-onset GDM diagnosed by OGTT at 18 to 20 gws is associated with maternal and neonatal metabolic disorders and adverse pregnancy outcomes. Further randomized controlled trials on the therapeutic efficacy for early-onset GDM will confirm the significance of early screening for GDM.

Liu B ，Cai J ，Xu Y ，Long Y ，Deng L ，Lin S ，Zhang J ，Yang J ，Zhong L ，Luo Y ，Zhou Y ，Zhang Y ，Li Z ，Chen H ，Wang Z ... -  《-》

Gestational diabetes mellitus (GDM) screening in morbidly obese pregnant women.

To study the outcomes of two-stage GDM screening of morbidly obese women in our obstetric unit and to evaluate the diagnostic performance of 20-week oral glucose tolerance test (OGTT) values in predicting or excluding late onset GDM. A retrospective study in which 190 pregnant women with BMI ≥40 had two-stage screening: a 75g OGTT is performed at 20 weeks and repeated at 28 weeks if the 20-week OGTT was normal. Receiver operating characteristic (ROC) curves for 20-week OGTT values were constructed in order to obtain an optimal cut-off value of fasting and/or 2-h glucose at 20 weeks from which GDM could be predicted or excluded at 28 weeks. Sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were determined for each of the fasting and 2-h post-load glucose values at 20 weeks. Forty six (24%) women were diagnosed with GDM. Thirty-two (70%) were diagnosed at 20 weeks and 14 (30%) at 28 weeks. The 2-h cut-off value of ≥6mmol/l at the 20-week OGTT had a negative likelihood ratio of 0.12 to predict GDM at 28 weeks. The low negative likelihood ratio reduces the probability of detecting GDM at 28 weeks from 9% (pre-test probability) to 1% (post-test probability). Nearly 70% of the women were diagnosed with GDM at 20 weeks, which gives an early opportunity to treat maternal hyperglycaemia with consequent health benefits. A 2-h cut-off glucose value of 6mmol/l at 20 weeks OGTT has a low negative likelihood ratio which virtually excludes GDM at 28 weeks. Hence women with a 2h value of <6mmol/l at 20 weeks can avoid a repeat 28 week OGTT test.

Gandhi P ，Farrell T 《-》

Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial.

As the accurate diagnosis and treatment of gestational diabetes mellitus (GDM) is of increasing importance; new diagnostic approaches for the assessment of GDM in early pregnancy were recently suggested. We evaluate the diagnostic power of an 'early' oral glucose tolerance test (OGTT) 75 g and glycosylated fibronectin (glyFn) for GDM screening in a normal cohort. In a prospective cohort study, 748 singleton pregnancies are recruited in 6 centres in Switzerland, Austria and Germany. Women are screened for pre-existing diabetes mellitus and GDM by an 'early' OGTT 75 g and/or the new biomarker, glyFn, at 12-15 weeks of gestation. Different screening strategies are compared to evaluate the impact on detection of GDM by an OGTT 75 g at 24-28 weeks of gestation as recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). A new screening algorithm is created by using multivariable risk estimation based on 'early' OGTT 75 g and/or glyFn results, incorporating maternal risk factors. Recruitment began in May 2014. This study received ethical approval from the ethics committees in Basel, Zurich, Vienna, Salzburg and Freiburg. It was registered under http://www.ClinicalTrials.gov (NCT02035059) on 12 January 2014. Data will be presented at international conferences and published in peer-reviewed journals. NCT02035059.

Huhn EA ，Fischer T ，Göbl CS ，Todesco Bernasconi M ，Kreft M ，Kunze M ，Schoetzau A ，Dölzlmüller E ，Eppel W ，Husslein P ，Ochsenbein-Koelble N ，Zimmermann R ，Bäz E ，Prömpeler H ，Bruder E ，Hahn S ，Hoesli I ... -  《BMJ Open》

[Comparing two screening policies of gestational diabetes mellitus: The Mohammed V Training Military Hospital of Rabat (Morocco)].

We wanted to measure the impact of going from a two-step screening for gestational diabetes mellitus (50g oral glucose tolerance test then 100g OGTT) to a one-step screening 75g OGTT (WHO's recommendations). A prospective study was carried out among patients who consulted between July 1st, 2008 and October 31st, 2009. The screening was performed in the first trimester if risk factors were identified and between 24 and 28 weeks of gestation (WG). During our period of study of 15 months, 706 pregnant women were included. The prescription of a screening test was performed in 403 women, i.e. 57% of cases. Out of the 403-screened women, 33 had gestational diabetes mellitus (GDM) i.e. a 8.2% prevalence rate. In univariate analysis, the following are considered to be risk factors: age, diabetes family history and macrosomia history in a previous pregnancy. Between 24 and 28 WG, 34.34% of the screening tests were achieved. The 75g OGTT is prescribed in 96.2% of cases as a screening test of GDM but fasting blood glucose is still prescribed in 3.8% of cases. Also, before 12 WG, 75g OGTT represent 64.7% of the prescribed tests. Despite the simplification of the GDM screening procedure, our work shows no significant difference of the screening rate and prevalence of GDM between our present study and the first work done in the same service (57% versus 61%, P=0.7 and 8.2% versus 7.7%, P=0.9). The GDM risk factors found are also identical between the two studies: age, type 2 diabetes family history and macrosomia history. Moreover, there is a statistically significant improvement in the screening age (23±6.7 versus 20.9 WG±6.8 in the first half of 2008, P<0.001) and the number of tests ordered during the period between 24 and 28 WG (34.34% versus 23.9% in the first half of 2008, P<0.001). For the GDM screening tests between 24 and 28 WG, 75g OGTT replaced the 50g OGTT (test used in the first study), but fasting blood glucose is prescribed in 3.8% of cases knowing that normal fasting blood glucose alone done between 24 and 28 WG has a poor sensitivity and do not exclude the diagnosis of GDM (Cosson, 2006) [11]. Also, before 12 WG, 75g OGTT represents 64.7% of the prescribed tests. However, there is to date no data to validate load testing before 24 WG. Our comparative study revealed maintenance of low implementation of universal screening of GDM despite the simplification of the protocol. Between 24 and 28 WG, 75g OGTT replaced the 50g OGTT, but fasting blood glucose was still prescribed. A sensitization meeting involving all intervening persons is to be organized with proposals for corrective actions. The final objective is the systematic screening of gestational diabetes mellitus with the use of fasting blood glucose in the first trimester and the 75g OGTT between 24 and 28 weeks of gestation.

Bouhsain S ，El Kochri S ，Babahabib MA ，Hafidi MH ，Bouaiti E ，Moussaoui MD ... -  《-》