Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects

Am J Obstet Gynecol. 2008 Feb;198(2):186.e1-7. doi: 10.1016/j.ajog.2007.08.005. Epub 2007 Oct 1.

Abstract

Objective: The objective of the study was a comparison of insulin aspart (IAsp) with human insulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy.

Study design: This was a randomized, parallel, open-label, controlled, multicenter, multinational study. Subjects were pregnant (gestational age; <10 weeks) or planning pregnancy at enrollment. Three hundred twenty-two women with type 1 diabetes received IAsp (n = 157) or HI (n = 165).

Results: For IAsp and HI, respectively, there were 137 and 131 live births and 14 and 21 fetal losses. Perinatal mortality was 14 and 22 per 1000 births; number of congenital malformations were 6 and 9; mean (SEM) birthweight corrected for gestational age was 3438 g (71.5) and 3555 g (72.9; P = .091). Mean gestational age was 37.6 vs 37.4 weeks. Preterm delivery occurred in 20.3% (IAsp) and 30.6% (HI) of pregnancies (P = .053).

Conclusion: The fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Denmark
  • Diabetes Mellitus, Type 1*
  • Diabetes, Gestational / blood
  • Diabetes, Gestational / drug therapy*
  • Diabetes, Gestational / mortality
  • Female
  • Glycated Hemoglobin A
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use*
  • Infant, Newborn
  • Insulin / administration & dosage
  • Insulin / analogs & derivatives*
  • Insulin / therapeutic use*
  • Insulin Aspart
  • Male
  • Pregnancy
  • Pregnancy Outcome
  • Stillbirth
  • Treatment Outcome

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • Insulin Aspart