title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov: NCT01892319 (date registered: 27.06.2013).
authors.affiliation: Department of Endocrinology, Center for Pregnant Women with Diabetes, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, DK-2100, Copenhagen, Denmark. elisabeth.mathiesen@rh.regionh.dk.|Department of Obstetrics, Center for Pregnant Women with Diabetes, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. elisabeth.mathiesen@rh.regionh.dk.
authors.forename: Elisabeth R
authors.initials: ER
authors.lastname: Mathiesen
authors.affiliation: Novo Nordisk A/S, Bagsværd, Denmark.
authors.forename: Henning
authors.initials: H
authors.lastname: Andersen
authors.affiliation: Epidemiology Department, Global Development, Novo Nordisk A/S, Bagsværd, Denmark.
authors.forename: Sofia I I
authors.initials: SI
authors.lastname: Kring
authors.affiliation: Department of Endocrinology, Center for Pregnant Women with Diabetes, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, DK-2100, Copenhagen, Denmark.|Department of Obstetrics, Center for Pregnant Women with Diabetes, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Damm
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000328:Adult; D003920:Diabetes Mellitus / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D007231:Infant, Newborn; D000069057:Insulin Detemir / Q000009:adverse effects*; D066087:Perinatal Death / Q000209:etiology*; D011247:Pregnancy; D011254:Pregnancy in Diabetics / Q000188:drug therapy*; D011446:Prospective Studies; D012107:Research Design
chemical_list: D007004:Hypoglycemic Agents; D000069057:Insulin Detemir
keywords: Cohort study; Diabetes; Insulin detemir; Pregnancy