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Perinatal Outcomes in a Randomized Trial Comparing Insulin Detemir with NPH Insulin in 310 Pregnant Women with Type 1 Diabetes

Results: The aim of this prospective, randomized, controlled, parallel-group, open-label trial was to compare the efficacy and safety of insulin detemir (IDet) vs. NPH insulin (both with mealtime insulin aspart) in type 1 diabetic pregnancy. Pregnant women with type 1 diabetes (HbA1c ≤8% at pregnancy confirmation) were randomized to IDet (n=152) or NPH (n=158) either before (up to 12 months) pregnancy (n=148) or during pregnancy (8-12 weeks gestation) (n=162). Pregnancy outcomes included a composite endpoint comprising: liveborn infants with birthweight <10th or >90th percentile for gestational age (GA) and sex ; preterm delivery (<37 gestational weeks (GWs)) ; early fetal demise <22 GWs) ; perinatal mortality ; neonatal mortality ; presence of major congenital malformations. There were 152 and 160 pregnancies in the IDet and NPH groups, respectively (2 women in the NPH group had a miscarriage and became pregnant again, without withdrawing). 25 pregnant women withdrew from the trial (10 IDet/15 NPH) ; therefore pregnancy outcome is reported for 142 and 145 women, respectively. 89 (62.7%) of IDet vs. 96 (66.2%) of NPH-treated subjects experienced ≥1 endpoint in the composite outcome (Odds ratio (OR) IDet/NPH: 0.86 [95% CI 0.53 ; 1.40], p=0.551). Maternal and neonatal outcomes for liveborn children were similar between groups (table). 17 children (8 IDet/9 NPH) had congenital malformations. There were 3 perinatal deaths (2 IDet/1 NPH). When administered to pregnant women with type 1 diabetes, IDet is as well-tolerated as NPH with respect to perinatal morbidity and mortality.

perinatal outcomes; Detemir; NPH; pregnancy; type 1 diabetes

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