BackgroundGestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women.Methods/designPregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose<5.1mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5 mmol) and randomized to one of the 8 intervention arms using a 2×(2×2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5kg and either 7 healthy eating ‘messages’ and/or 5 physical activity ‘messages’ depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24–28 weeks, 35–37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight.DiscussionDALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women.Trial registrationISRCTN70595832
Background-The aim of the study was to evaluate the relation between maternal placental Doppler velocimetry, levels of the maternal glucose, and clinical signs of vasculopathy in pregnancy complicated by pregestational diabetes mellitus. Methods and Results-A retrospective study of 155 pregestational diabetic women between the 22nd and 40th weeks of pregnancy, categorized in White classification as B, 49; C, 40; D, 22; R,20; F,5; and RIF,19. Cases in classes R, F, and R/F were defined as having vasculopathy. Doppler velocimetry of umbilical and uterine arteries was evaluated for vascular impedance, both in terms of pulsatility index (PI) for both arteries and a notch in early diastole in the uterine arteries. The last examination before delivery was used for analysis. Increased umbilical artery PI was seen in 19 and a uterine artery abnormality in 45 cases. There was a correlation between levels of HbA lc and increased vascular impedance in the uterine and umbilical arteries. Signs of increased uterine artery vascular impedances were significantly related to pregestational vasculopathy. In cases of small-for-gestational-age newborn infants, PI was significantly increased in uterine and umbilical arteries. Furthermore, PI in macrosomic fetuses was significantly lower than in normal infants. Abnormal uterine artery Doppler was also strongly related to adverse outcome. Conclusions-Abnormal
Objective. Assess the impact of Gestational Diabetes Mellitus (GDM) and obesity on neonatal and maternal pregnancy outcomes. Methods. Cross-sectional data (3343 pregnancies) from seven European centres were included in a multilevel analysis of the association between GDM/obesity and caesarean section, macrosomia and neonatal morbidities. Results. Comparison of databases identified reporting differences between countries due to the inclusion of true population based samples or pregnancies from specialised tertiary centres, resulting in higher prevalences of GDM for some countries. The analysis showed that obesity and GDM were independent risk factors of perinatal complications. Only BMI had a dose-dependent effect on the risk of macrosomia and caesarean section. Both obesity (BMI > 30 kg/m2) and GDM were independent risk factors of neonatal morbidities. Conclusions. Obesity and GDM were independent risk factors of perinatal complications. The effect of the worldwide obesity and diabetes epidemic is extending to the next generation.
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