Table 3

Relative risk of non-chromosomal congenital anomalies by treatment of diabetes in the first trimester

Human insulin only,
N=463
Insulin analogue only,
N=311
Human insulin and insulin analogue, N=273
Major congenital anomaly
 n (%)37 (8.0)14 (4.5)10 (3.7)
 Crude OR (95% CI)Reference0.54 (0.29 to 1.01)0.43 (0.21 to 0.89)
 Adjusted OR (95% CI)*Reference0.56 (0.29 to 1.06)0.44 (0.22 to 0.91)
Congenital heart defects
 n (%)21 (4.5)2 (0.6)6 (2.2)
 Crude OR (95% CI)Reference0.14 (0.03 to 0.58)0.46 (0.18 to 1.15)
 Adjusted OR (95% CI)*Reference0.14 (0.03 to 0.62)0.47 (0.19 to 1.19)
Adverse outcomes†
 n (%)42 (9.1)21 (6.8)19 (7.0)
 Crude OR (95% CI)Reference0.72 (0.42 to 1.24)0.74 (0.42 to 1.31)
 Adjusted OR (95% CI)*Reference0.76 (0.44 to 1.33)0.77 (0.44 to 1.36)
  • *Adjusted for centre as a random effect and adjusted for HbA1c value in the first trimester.

  • †Including major congenital anomaly or fetal deaths.

  • HbA1c, haemoglobin A1c.