Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins

BACKGROUND: There are a lack of data regarding the effect of basal insulin analogues on rates of events like congenital malformation and perinatal mortality in diabetic pregnancy. METHODS: The present study is a prospective, non-interventional, multicentre cohort study conducted in seven countries, designed to assess the safety of insulin detemir during pregnancy, and to monitor the health status of resulting infants (exposed in utero) up to 1 year of age. The study population includes women with type 1 or type 2 diabetes, who are pregnant and being treated with insulin. Data will be collected in the context of routine practice. The primary endpoint is the proportion of pregnancies in women treated with insulin detemir, compared with other basal insulin regimens, which do not result in any of the following events: major congenital malformations, perinatal death or neonatal death. A sample size of 3075 pregnancies was calculated to provide an 80% power to detect a difference of 3.5% between groups in the primary endpoint at a 5% level. DISCUSSION: The study will also examine other important maternal endpoints (e.g., incidences of severe hypoglycaemia and pre-eclampsia) and perinatal outcomes such as overweight neonates, as well as infant outcomes at 1 year of age. It has a fixed recruitment period from 2013 to 2018, enrolling all eligible patients, and is expected to inform future prescribing with basal insulins in diabetic pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01892319 (date registered: 27.06.2013). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12884-016-1177-4) contains supplementary material, which is available to authorized users

Grain size limits derived from 3.6 {\mu}m and 4.5 {\mu}m coreshine

Recently discovered scattered light from molecular cloud cores in the wavelength range 3-5 {\mu}m (called "coreshine") seems to indicate the presence of grains with sizes above 0.5 {\mu}m. We aim to analyze 3.6 and 4.5 {\mu}m coreshine from molecular cloud cores to probe the largest grains in the size distribution. We analyzed dedicated deep Cycle 9 Spitzer IRAC observations in the 3.6 and 4.5 {\mu}m bands for a sample of 10 low-mass cores. We used a new modeling approach based on a combination of ratios of the two background- and foreground-subtracted surface brightnesses and observed limits of the optical depth. The dust grains were modeled as ice-coated silicate and carbonaceous spheres. We discuss the impact of local radiation fields with a spectral slope differing from what is seen in the DIRBE allsky maps. For the cores L260, ecc806, L1262, L1517A, L1512, and L1544, the model reproduces the data with maximum grain sizes around 0.9, 0.5, 0.65, 1.5, 0.6, and > 1.5 {\mu}m, respectively. The maximum coreshine intensities of L1506C, L1439, and L1498 in the individual bands require smaller maximum grain sizes than derived from the observed distribution of band ratios. Additional isotropic local radiation fields with a spectral shape differing from the DIRBE map shape do not remove this discrepancy. In the case of Rho Oph 9, we were unable to reliably disentangle the coreshine emission from background variations and the strong local PAH emission. Considering surface brightness ratios in the 3.6 and 4.5 {\mu}m bands across a molecular cloud core is an effective method of disentangling the complex interplay of structure and opacities when used in combination with observed limits of the optical depth.Comment: 23 pages, 18 figures, accepted for publication in A&