Sensitivity, specificity, and diagnostic accuracy of WHO 2013 criteria for diagnosis of gestational diabetes mellitus in low risk early pregnancies: international, prospective, multicentre cohort study

Objective: To evaluate the predictability of gestational diabetes mellitus wth a 75 g oral glucose tolerance test (OGTT) in early pregnancy, based on the 2013 criteria of the World Health Organization, and to test newly proposed cut-off values. Design: International, prospective, multicentre cohort study.SettingSix university or cantonal departments in Austria, Germany, and Switzerland, from 1 May 2016 to 31 January 2019.ParticipantsLow risk cohort of 829 participants aged 18-45 years with singleton pregnancies attending first trimester screening and consenting to have an early 75 g OGTT at 12-15 weeks of gestation. Participants and healthcare providers were blinded to the results. Main outcome measures: Fasting, one hour, and two hour plasma glucose concentrations after an early 75 g OGTT (12-15 weeks of gestation) and a late 75 g OGTT (24-28 weeks of gestation). Results: Of 636 participants, 74 (12%) developed gestational diabetes mellitus, according to World Health Organization 2013 criteria, at 24-28 weeks of gestation. Applying WHO 2013 criteria to the early OGTT with at least one abnormal value gave a low sensitivity of 0.35 (95% confidence interval 0.24 to 0.47), high specificity of 0.96 (0.95 to 0.98), positive predictive value of 0.57 (0.41 to 0.71), negative predictive value of 0.92 (0.89 to 0.94), positive likelihood ratio of 10.46 (6.21 to 17.63), negative likelihood ratio of 0.65 (0.55 to 0.78), and diagnostic odds ratio of 15.98 (8.38 to 30.47). Lowering the postload glucose values (75 g OGTT cut-off values of 5.1, 8.9, and 7.8 mmol/L) improved the detection rate (53%, 95% confidence interval 41% to 64%) and negative predictive value (0.94, 0.91 to 0.95), but decreased the specificity (0.91, 0.88 to 0.93) and positive predictive value (0.42, 0.32 to 0.53) at a false positive rate of 9% (positive likelihood ratio 5.59, 4.0 to 7.81; negative likelihood ratio 0.64, 0.52 to 0.77; and diagnostic odds ratio 10.07, 6.26 to 18.31). Conclusions: The results of this prospective low risk cohort study indicated that the 75 g OGTT as a screening tool in early pregnancy is not sensitive enough when applying WHO 2013 criteria. Postload glucose values were higher in early pregnancy complicated by diabetes in pregnancy. Lowering the postload cut-off values identified a high risk group for later development of gestational diabetes mellitus or those who might benefit from earlier treatment. Results from randomised controlled trials showing a beneficial effect of early intervention are unclear. Trial registrationClinicalTrials.govNCT02035059

Politiche locali per rom e sinti in Italia

Al contrario di quanto osservato e studiato sulle politiche locali per migranti, gli studi che sono stati finora condotti sulle politiche locali nei confronti dei rom e sinti in Italia dimostrano chiaramente come disattenzione e abbandono, esclusione e discriminazione, oltre a essere storicamente ben radicati, abbiano tragicamente costituito la norma di moltissime realt\ue0 locali negli ultimi decenni, in particolare a partire dagli anni '80 del Novecento. In un certo senso, lo studio delle politiche locali verso rom e sinti ha seguito finora un orientamento opposto rispetto a quello relativo alle politiche locali verso i migranti: mentre in quest\u2019ultimo caso si \ue8 passati dallo studio delle cosiddette \u201cpolitiche di integrazione dei migranti\u201d a quello delle \u201cnuove\u201d politiche di esclusione, nel primo caso si \ue8 passati dall'osservazione e dalla denuncia delle politiche di esclusione alla ricognizione di diverse politiche di inclusione. Queste ultime restano tuttavia ancora molto poco visibili. Permane oggi una forte visibilit\ue0 delle politiche escludenti attuate nei confronti di rom e sinti, visibilit\ue0 dovuta alla violenza strutturale insita in questo tipo di interventi, sebbene sappiamo che da almeno vent'anni si stiano sperimentando in molti luoghi e in tutta Italia altre politiche, pi\uf9 o meno inclusive, ma certamente \u201cpossibili\u201d. \u201cPossibili\u201d perch\ue9 gi\ue0 realizzate in diversi contesti e perch\ue9 si basano su un maggiore scambio tra le parti sociali, in grado di dare pi\uf9 voce ai rom e ai sinti, configurandosi dunque anche come delle \u201cpolitiche della possibilit\ue0\u201d. Nonostante sia stata riconosciuta e attestata la sperimentazione di politiche locali \u201cpossibili\u201d e \u201cdella possibilit\ue0\u201d per rom e sinti in diverse citt\ue0 d\u2019Italia, non disponiamo al momento di studi condotti in profondit\ue0 e con prospettiva diacronica su queste politiche. L\u2019intento di questo volume \ue8 quello di iniziare a colmare un gap di ricerca proponendo alcuni studi di caso condotti in profondit\ue0 e in prospettiva diacronica su diverse politiche per rom e sinti realizzate a livello locale in Italia. Il volume risulta dunque costituito da cinque studi di caso su diverse citt\ue0 italiane (Milano, Bari, Verona, Roma, Modena), pi\uf9 due saggi sulle rappresentazioni dei rom e dei sinti di politici locali italiani e sull'uso delle questioni rom da parte dei politici italiani e francesi nell'arena politica del web. Il volume cerca nel complesso di delineare elementi comparativi di rilievo e tracce per future ricerche sulle politiche locali per rom e sinti in Italia

Lactate in Amniotic Fluid: Predictor of Labor Outcome in Oxytocin-Augmented Primiparas' Deliveries.

One of the major complications related to delivery is labor dystocia, or an arrested labor progress. Many dystocic deliveries end vaginally after administration of oxytocin, but a large numbers of women with labor dystocia will undergo a long and unsafe parturition. As a result of the exertion required in labor, the uterus produces lactate. The uterine production of lactate is mirrored by the level of lactate in amniotic fluid (AFL).To evaluate whether the level of AFL, analysed in a sample of amniotic fluid collected vaginally at arrested labor when oxytocin was needed, could predict labor outcome in nulliparous deliveries.A prospective multicentre study including 3000 healthy primiparous women all with a singleton pregnancy, gestational age 37 to 42 weeks and no maternal /fetal chronic and/or pregnancy-related conditions. A spontaneous onset of labor, regular contractions and cervical dilation ≥ 3 cm were required before the women were invited to take part in the study.AFL, analysed within 30 minutes before augmentation, provides information about delivery outcome. Sensitivity for an acute cesarean section according to high (≥10.1mmol/l) or low (12h (p = 0.04), post-partum fever (>38°C, p = 0.01) and post-partum haemorrhage >1.5L (p = 0.04).The AFL is a good predictor of delivery outcome in arrested nulliparous deliveries. Low levels of AFL may support the decision to continue a prolonged vaginal labor by augmentation with oxytocin. A high level of AFL correlates with operative interventions and post-partum complications

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

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT02035059

Delivery data presented per high/low AFL value at the time of augumentation.

<p>Data are presented as numbers (%), n = 638.</p

Maternal and fetal background data presented per country for deliveries with a sample of amniotic fluid collected at the time of labor.

<p>Data are presented as numbers (%) or mean (SD) n = 2049.</p

Sensitivity, Specificity, Positive (PPV) and Negative Predictive value (NPV) for operative delivery among 638 deliveries where oxytocin was used and an AF sample was collected within 30 minutes before commencing stimulation with oxytocin.

<p>The AFL values were used for predictive purposes.</p

Risk of congenital malformation following first trimester mRNA COVID-19 vaccine exposure in pregnancy: the COVI-PREG prospective cohort.

OBJECTIVES This study aimed to evaluate the risk of congenital malformation among pregnant women exposed to the mRNA COVID-19 vaccines during the first trimester of pregnancy, which is a developmental period where the fetus is at risk of teratogenicity. METHODS Pregnant women were prospectively enrolled from March 2021 to March 2022, at the time of COVID-19 vaccination. Pregnant women exposed to at least one dose of mRNA COVID-19 vaccine from conception to 11 weeks of gestations and 6 days were compared to pregnant women exposed to the vaccine from 12 weeks to the end of pregnancy. The primary outcome was a confirmed congenital malformation at birth. RESULTS A total of 1450 pregnant women were enrolled including 124 in the first trimester and 1326 in the second and third trimester. The overall proportion of congenital malformation was 0.81% (n=1/124; 95%CI 0.02-4.41) and 0.83% (n=11/1326; 95% CI 0.41-1.48) among pregnant exposed to the COVID-19 vaccine during the first and second/third trimester, respectively. First trimester exposure was not associated with a higher risk of congenital malformation with a relative risk (RR) of 0.89 (95%CI 0.12-6.80) with no significant changes after adjustment through exploratory analysis. CONCLUSION Pregnant women exposed to mRNA COVID-19 vaccine before 12 weeks of gestation did not have an increased risk of congenital malformation compared to women exposed outside the teratogenic window. As vaccination is safe and effective, emphasis must be placed on promoting vaccination during pregnancy

Risk of congenital malformation following first trimester mRNA COVID-19 vaccine exposure in pregnancy: the COVI-PREG prospective cohort.

This study aimed to evaluate the risk of congenital malformation among pregnant women exposed to the mRNA COVID-19 vaccines during the first trimester of pregnancy, which is a developmental period where the fetus is at risk of teratogenicity. Pregnant women were prospectively enrolled from March 2021 to March 2022, at the time of COVID-19 vaccination. Pregnant women exposed to at least one dose of mRNA COVID-19 vaccine from conception to 11 weeks of gestations and 6 days were compared to pregnant women exposed to the vaccine from 12 weeks to the end of pregnancy. The primary outcome was a confirmed congenital malformation at birth. A total of 1450 pregnant women were enrolled including 124 in the first trimester and 1326 in the second and third trimester. The overall proportion of congenital malformation was 0.81% (n=1/124; 95%CI 0.02-4.41) and 0.83% (n=11/1326; 95% CI 0.41-1.48) among pregnant exposed to the COVID-19 vaccine during the first and second/third trimester, respectively. First trimester exposure was not associated with a higher risk of congenital malformation with a relative risk (RR) of 0.89 (95%CI 0.12-6.80) with no significant changes after adjustment through exploratory analysis. Pregnant women exposed to mRNA COVID-19 vaccine before 12 weeks of gestation did not have an increased risk of congenital malformation compared to women exposed outside the teratogenic window. As vaccination is safe and effective, emphasis must be placed on promoting vaccination during pregnancy