Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study

Hao Wang, Ewa Wender-Ozegowska, Ester Garne, Margery Morgan, Maria Loane, Joan K Morris, Marian Bakker, Miram Gatt, Hermien deWalle, Susan Jordan, Anna Materna-Kiryluk, Vera Nelen, Guy Thys, Awi Wiesel, Helen Dolk, Lolkje TW de Jong-van den Berg

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

AbstractObjectives To evaluate the risk of major congenital anomaly associated with first-trimester exposure to insulin analogues compared with human insulin in offspring of women with pregestational diabetes.Design and setting A population-based cohort of women with pregestational diabetes (n=1661) who delivered between 1996 and 2012 was established retrospectively from seven European regions covered bythe European Surveillance of Congenital Anomalies (EUROCAT) congenital anomaly registries.Primary outcome measures The risk of non-chromosomal major congenital anomaly in live births, fetal deaths and terminations for a fetal anomaly exposed to insulin analogues in the first trimester of pregnancy was compared with the risk in those exposed to human insulin only.Results During the first trimester, 870 fetuses (52.4%) were exposed to human insulin only, 397 fetuses (23.9%) to insulin analogues only and 394 fetuses (23.7%) to both human insulin and insulin analogues. The risk of major congenital anomaly in fetuses exposed to insulin analogues only was lower than those exposed to human insulin only; the relative risk adjusted for glycaemic control and region was 0.56 (95% CI 0.29 to 1.06). The significantly lower risk related to exposure of insulin analogues only was observed in congenital heart defects: adjusted relative risk 0.14 (95% CI 0.03 to 0.62).Conclusions In this retrospective population-based cohort study across Europe, first-trimester exposure to insulin analogues did not increase the risk of major congenital anomaly compared with exposure to human insulin. A possible lower risk of congenital heart defects among fetuses exposed to insulin analogues only deserves further investigation.
Original languageEnglish
JournalBMJ Open
Volume8
Issue number2
Early online date24 Feb 2018
DOIs
Publication statusE-pub ahead of print - 24 Feb 2018

Keywords

  • Diabetes in pregnancy
  • epidemiology
  • maternal medicine
  • congenital anomalies
  • first trimester

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