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)	Reference	0.54 (0.29 to 1.01)	0.43 (0.21 to 0.89)
Adjusted OR (95% CI)*	Reference	0.56 (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)	Reference	0.14 (0.03 to 0.58)	0.46 (0.18 to 1.15)
Adjusted OR (95% CI)*	Reference	0.14 (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)	Reference	0.72 (0.42 to 1.24)	0.74 (0.42 to 1.31)
Adjusted OR (95% CI)*	Reference	0.76 (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.