Table 1.

Fetal and perinatal outcomes.

	IDet		NPH		Odds ratio [95% CI]	p Value
	n	%	n	%
Number of subjects	152	–	158	–	–	–
Number of pregnancies	152	–	160	–	–	–
Pregnancy outcome at follow-up	142		145		–	–
Live births‡	128	90.1	136*	93.8	0.61 [0.25;1.50]	p = 0.284
Early fetal death‡	11	7.7	9	6.2	–	–
Spontaneous abortion	10	7.0	8	5.5	–	–
Ectopic pregnancy	1	0.7	1	0.7	–	–
Induced abortion‡	1	0.7	0	0.0	–	–
Perinatal death‡	2	1.4	1	0.7	–	–
Neonatal death‡	0	0.0	0	0.0	–	–
Composite outcome: at least one issue present‡	89	62.7	96	66.2	0.86 [0.53;1.40]	p = 0.551
Preterm delivery (<37 weeks)¶	26	20.3	36	26.5	0.71 [0.40;1.26]	p = 0.238
Small† for GA (<10th percentile)¶	3	2.3	1	0.7	–	–
Large† for GA (>90th percentile)¶	59	46.1	73	53.7	0.74 [0.46;1.21]	p = 0.228
Macrosomia (>4000 g)¶	24	18.8	35	25.7	0.67 [0.37;1.20]	p = 0.180
Neonatal hypoglycemia <24 hours post-delivery¶	15	11.7	24	17.6	0.65 [0.32;1.30]	p = 0.223
	IDet		NPH		Treatment difference [95% CI]	p Value
	Mean	SD	Mean	SD
Birth weight (g)§	3504	645	3571	601	−41.8 [–191.0;107.1]	p = 0.581
GA at delivery (weeks)§	38.2	1.9	37.8	1.5	0.49 [0.11;0.88]	p = 0.012

^*There is 1 less live child at follow-up compared with live births as 1 liveborn child died shortly after birth (classified as a perinatal death);

^†Refers to body weight;

^‡Percentage of pregnancy outcomes at follow-up;

^¶Percentage of live births;

^§Analyses based on live births.

GA, gestational age; g, grams; IDet, insulin detemir; NPH, neutral protamine Hagedorn.