Table 2.

Congenital malformations as diagnosed by two independent experts.

Group	MedDRA preferred term	Basal insulin at organogenesis	Expert 1 classification	Expert 2 (blinded post hoc) classification
Pregnant at randomization
	Hip dysplasia	IDet	Major (reclassified to minor due to FU information)	Not a congenital malformation (developmental disorder that disappears)
	Cleft lip	NPH	Major	Major
IDet (n = 79)	Meningomyelocele	NPH	Major	Major
	Atrial septal defect Hemangioma congenital	NPH	Both minor	Both major
	Hemangioma congenital (diagnosed after the EOT)	NPH	Minor	Not a congenital malformation
	Dandy–Walker syndrome Pulmonary hypoplasia	NPH	Both major	Both major
	Polydactyly	Insulin glargine	Minor	Minor
NPH (n = 83)	Cardiac hypertrophy Patent ductus arteriosus	NPH	Both minor	Not congenital malformations (FU: patent ductus arteriosus was minor and did not require surgery)
	Atrial septal defect	NPH	Minor	Not a congenital malformation (FU: atrial septal defect spontaneously closed)
Pregnant after randomization
	Congenital hydronephrosis Pelviureteric obstruction Pyelocaliectasis	IDet	All major	All major
IDet (n = 73)	Hydronephrosis	IDet	Major	Major
	Heart disease congenital	IDet	Minor	Not a congenital malformation. Transient minor anomaly
NPH (n = 75)	Heart disease congenital	NPH	Minor	Not a congenital malformation. Transient minor anomaly
	Congenital laryngeal stridor	NPH	Minor	Not a congenital malformation
	Atrial septal defect	NPH	Minor	Major
	Ventricular septal defect	NPH	Minor	Major
	Pelvic kidney* (diagnosed after mother was withdrawn while pregnant due to A1C >8% [>64 mmol/mol] at confirmation of pregnancy	NPH	Major	Major

^*This malformation from a woman withdrawn from the study is not included in the trial database or further calculations.

Follow-up was from birth until 6 weeks after birth.

A1C, glycated hemoglobin; EOT, end of trial; FU, follow-up; IDet, insulin detemir; MedDRA, Medical Dictionary for Regulatory Activities; NPH, neutral protamine Hagedorn.