OBJECTIVE: 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. STUDY DESIGN: This 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). RESULTS: For 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). CONCLUSION: The fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.
RCT Entities:
OBJECTIVE: The objective of the study was a comparison of insulin aspart (IAsp) with humaninsulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy. STUDY DESIGN: This 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). RESULTS: For 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). CONCLUSION: The fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.
Authors: Rachel A Haws; Mohammad Yawar Yakoob; Tanya Soomro; Esme V Menezes; Gary L Darmstadt; Zulfiqar A Bhutta Journal: BMC Pregnancy Childbirth Date: 2009-05-07 Impact factor: 3.007
Authors: D R McCance; P Damm; E R Mathiesen; M Hod; R Kaaja; F Dunne; L E Jensen; H Mersebach Journal: Diabetologia Date: 2008-08-23 Impact factor: 10.122
Authors: Sinéad M O'Neill; Louise C Kenny; Ali S Khashan; Helen M West; Rebecca Md Smyth; Patricia M Kearney Journal: Cochrane Database Syst Rev Date: 2017-02-03
Authors: Anna Maria Hibbs; Dennis Black; Lisa Palermo; Avital Cnaan; Xianqun Luan; William E Truog; Michele C Walsh; Roberta A Ballard Journal: J Pediatr Date: 2009-12-06 Impact factor: 4.406