Table 3.

Summary of congenital malformations by randomized treatment and treatment during organogenesis for children delivered during the trial.

Group	Expert 1 classification				Expert 2 (blinded post hoc) classification
Randomized treatment	IDet (n = 142)		NPH (n = 145)		IDet (n = 142)		NPH (n = 145)
	n	%	n	%	n	%	n	%
Children with congenital malformations	8	5.6	8*	5.5	5	3.5	4*	2.8
Minor	3	2.1	7	4.8	0	0.0	1	0.7
Major	5	3.5	1	0.7	5	3.5	3	2.1
Treatment during organogenesis†	IDet (n = 84)		NPH (n = 154)		IDet (n = 84)		NPH (n = 154)
	n	%	n	%	n	%	n	%
Children with congenital malformations	4	4.8	11	7.1	2	2.4	6	3.9
Minor	1	1.2	8	5.2	0	0.0	0	0.0
Major	3	3.6	3	1.9	2	2.4	6	3.9

^*There was one additional malformation (preferred term: pelvic kidney; treatment during organogenesis: NPH; randomized treatment: NPH; classification: major), that was diagnosed after the mother was withdrawn from the trial (detail in Table 2). As this table is based only on those women who gave birth during the trial, this malformation is not included.

^†Those subjects treated with a basal insulin other than IDet or NPH (n = 35) or who were unclassifiable (n = 14; i.e. used more than one basal insulin or had missing information about their basal insulin) were not included in the treatment during organogenesis calculations. The woman treated with insulin glargine during organogenesis (detail in Table 2) is not included.

IDet, insulin detemir; NPH, neutral protamine Hagedorn.