title: A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes.
abstract: OBJECTIVE
  This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented.
  
  
  METHODS
  Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks.
  
  
  RESULTS
  For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments.
  
  
  CONCLUSIONS
  IDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified.
authors.affiliation: Helen Schneider Women's Hospital, Rabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University , Tel Aviv , Israel .
authors.forename: Moshe
authors.initials: M
authors.lastname: Hod
authors.forename: Elisabeth R
authors.initials: ER
authors.lastname: Mathiesen
authors.forename: Lois
authors.initials: L
authors.lastname: Jovanovič
authors.forename: David R
authors.initials: DR
authors.lastname: McCance
authors.forename: Marina
authors.initials: M
authors.lastname: Ivanisevic
authors.forename: Santiago
authors.initials: S
authors.lastname: Durán-Garcia
authors.forename: Lise
authors.initials: L
authors.lastname: Brøndsted
authors.forename: Avideh
authors.initials: A
authors.lastname: Nazeri
authors.forename: Peter
authors.initials: P
authors.lastname: Damm
mesh_terms: D000028:Abortion, Induced / Q000706:statistics & numerical data; D000022:Abortion, Spontaneous / Q000453:epidemiology; D000013:Congenital Abnormalities / Q000453:epidemiology; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D005313:Fetal Death / Q000453:epidemiology; D005865:Gestational Age; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D061267:Insulin Aspart / Q000627:therapeutic use; D000069057:Insulin Detemir; D007336:Insulin, Isophane / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D050498:Live Birth / Q000453:epidemiology; D011247:Pregnancy; D011256:Pregnancy Outcome; D011254:Pregnancy in Diabetics / Q000188:drug therapy*; D011271:Pregnancy, Ectopic / Q000453:epidemiology
chemical_list: D004338:Drug Combinations; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D000069057:Insulin Detemir; D007336:Insulin, Isophane; D061267:Insulin Aspart