A1 Refereed original research article in a scientific journal
Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects
Authors: Hod M, Damm P, Kaaja R, Visser GH, Dunne F, Demidova I, Hansen AS, Mersebach H, Mersebach H
Publication year: 2008
Journal: American Journal of Obstetrics and Gynecology
Journal name in source: American journal of obstetrics and gynecology
Journal acronym: Am J Obstet Gynecol
Volume: 198
Issue: 2
First page : 186.e1
Last page: 7
Number of pages: 7
ISSN: 0002-9378
eISSN: 1097-6868
DOI: https://doi.org/10.1016/j.ajog.2007.08.005
Abstract
The objective of the study was a comparison of insulin aspart (IAsp) with human insulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy.\nThis was a randomized, parallel, open-label, controlled, multicenter, multinational study. Subjects were pregnant (gestational age; <10 weeks) or planning pregnancy at enrollment. Three hundred twenty-two women with type 1 diabetes received IAsp (n = 157) or HI (n = 165).\nFor IAsp and HI, respectively, there were 137 and 131 live births and 14 and 21 fetal losses. Perinatal mortality was 14 and 22 per 1000 births; number of congenital malformations were 6 and 9; mean (SEM) birthweight corrected for gestational age was 3438 g (71.5) and 3555 g (72.9; P = .091). Mean gestational age was 37.6 vs 37.4 weeks. Preterm delivery occurred in 20.3% (IAsp) and 30.6% (HI) of pregnancies (P = .053).\nThe fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.\nOBJECTIVE\nSTUDY DESIGN\nRESULTS\nCONCLUSION
The objective of the study was a comparison of insulin aspart (IAsp) with human insulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy.\nThis was a randomized, parallel, open-label, controlled, multicenter, multinational study. Subjects were pregnant (gestational age; <10 weeks) or planning pregnancy at enrollment. Three hundred twenty-two women with type 1 diabetes received IAsp (n = 157) or HI (n = 165).\nFor IAsp and HI, respectively, there were 137 and 131 live births and 14 and 21 fetal losses. Perinatal mortality was 14 and 22 per 1000 births; number of congenital malformations were 6 and 9; mean (SEM) birthweight corrected for gestational age was 3438 g (71.5) and 3555 g (72.9; P = .091). Mean gestational age was 37.6 vs 37.4 weeks. Preterm delivery occurred in 20.3% (IAsp) and 30.6% (HI) of pregnancies (P = .053).\nThe fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.\nOBJECTIVE\nSTUDY DESIGN\nRESULTS\nCONCLUSION
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