53 research outputs found

    The risk stratification of adverse neonatal outcomes in women with gestational diabetes (STRONG) study

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    Aims: To assess the risk of adverse neonatal outcomes in women with gestational diabetes (GDM) by identifying subgroups of women at higher risk to recognize the characteristics most associated with an excess of risk. Methods: Observational, retrospective, multicenter study involving consecutive women with GDM. To identify distinct and homogeneous subgroups of women at a higher risk, the RECursive Partitioning and AMalgamation (RECPAM) method was used. Overall, 2736 pregnancies complicated by GDM were analyzed. The main outcome measure was the occurrence of adverse neonatal outcomes in pregnancies complicated by GDM. Results: Among study participants (median age 36.8 years, pre-gestational BMI 24.8 kg/m2), six miscarriages, one neonatal death, but no maternal death was recorded. The occurrence of the cumulative adverse outcome (OR 2.48, 95% CI 1.59–3.87), large for gestational age (OR 3.99, 95% CI 2.40–6.63), fetal malformation (OR 2.66, 95% CI 1.00–7.18), and respiratory distress (OR 4.33, 95% CI 1.33–14.12) was associated with previous macrosomia. Large for gestational age was also associated with obesity (OR 1.46, 95% CI 1.00–2.15). Small for gestational age was associated with first trimester glucose levels (OR 1.96, 95% CI 1.04–3.69). Neonatal hypoglycemia was associated with overweight (OR 1.52, 95% CI 1.02–2.27) and obesity (OR 1.62, 95% CI 1.04–2.51). The RECPAM analysis identified high-risk subgroups mainly characterized by high pre-pregnancy BMI (OR 1.68, 95% CI 1.21–2.33 for obese; OR 1.38 95% CI 1.03–1.87 for overweight). Conclusions: A deep investigation on the factors associated with adverse neonatal outcomes requires a risk stratification. In particular, great attention must be paid to the prevention and treatment of obesity

    DEFLAZACORT VERSUS PREDNISONE/PREDNISOLONE FOR MAINTAINING MOTOR FUNCTION AND DELAYING LOSS OF AMBULATION: A POST HOC ANALYSIS FROM THE ACT DMD TRIAL

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    Introduction: ACT DMD was a 48-week trial of ataluren for nonsense mutation Duchenne muscular dystrophy (nmDMD). Patients received corticosteroids for ≥6 months at entry and stable regimens throughout study. This post hoc analysis compares efficacy and safety for deflazacort and prednisone/prednisolone in the placebo arm. Methods: Patients received deflazacort (n = 53) or prednisone/prednisolone (n = 61). Endpoints included change from baseline in 6-minutewalk distance (6MWD), timed function tests, estimated age at loss of ambulation (extrapolated from 6MWD). Results: Mean changes in 6MWD were -39.0 m (deflazacort; 95%confidence limit [CL], -68.85, -9.17) and -70.6 m (prednisone/prednisolone; 95% CL, -97.16, -44.02).Mean changes in 4-stair climb were 3.79 s (deflazacort; 95% CL, 1.54, 6.03) and 6.67 s (prednisone/prednisolone; 95% CL, 4.69, 8.64). Conclusions: This analysis, limited by its post hoc nature, suggests greater preservation of 6MWD and 4-stair climb with deflazacort vs. prednisone/prednisolone. A head-to-head comparisonwill better define these differences

    Level of implementation of guidelines on screening and diagnosis of gestational diabetes. a national survey

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    Aims: To describe the degree of diffusion and acceptance of national guideline on screening and diagnosis of gestational diabetes (GDM) among Italian diabetes centers and to detect possible areas for benchmarking. Methods: In 2013 the Italian Diabetes in Pregnancy Study Group structured a national survey, focused on GDM screening and diagnostic procedures, that was administered to diabetologists. Results: Overall, 122 diabetologists of 122 different diabetes centers (21.7% territorial, 78.3% hospital/University) completed the questionnaire. All respondents declared to execute a 75 g-oral glucose tolerance test (OGTT) as diagnostic test. Almost one in five centers preferred a universal screening procedure, the others executing a selective risk factors-based screening. In patients at high risk for GDM the OGTT was performed at 16-18 weeks' gestation in 84.0% of the cases; only 6.5% of respondents preferred to execute it as soon as possible; and 9.5% used to wait until 24-28 weeks' gestation. In the case of fasting plasma glucose (FPG) >5.1 mmol/l (92 mg/dl), two third of respondents used to proceed with the execution of the complete diagnostic OGTT, the others considering sufficient the FPG value for the diagnosis. Conclusions: Good level of reception of national recommendations was documented. The diagnostic procedure was generally accepted and applied. Some criticisms were specifically linked to the choice of universal or risk factor-based screening procedure, and to the right time for executing the OGTT in women at high risk
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