Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects

被引：114

作者：

Hod, Moshe ^{[1
]}

Damm, Peter ^{[2
]}

Kaaja, Risto ^{[3
]}

Visser, Gerard H. A. ^{[4
]}

Dunne, Fidelma ^{[5
]}

Demidova, Irina ^{[6
]}

Hansen, Anne-Sofie Pade ^{[7
]}

Mersebach, Henriette ^{[7
]}

机构：

[1] Tel Aviv Univ, Helen Schneider Hosp Women, Sackler Fac Med, Rabin Med Ctr,Perinatal Div, IL-49100 Petah Tiqwa, Israel

[2] Univ Copenhagen Hosp, Rigshosp, Dept Obstet, Ctr Pregnant Women Diabet, Copenhagen, Denmark

[3] Univ Helsinki, Cent Hosp, Dept Obstet & Gynecol, FIN-00290 Helsinki, Finland

[4] Univ Med Ctr, Dept Obstet, Utrecht, Netherlands

[5] Med Hlth Sci, Galway, Ireland

[6] City Hosp 1, Moscow, Russia

[7] Novo Nordisk AS, Modern Insulin, Global Dev, Bagsvaerd, Denmark

来源：

AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY | 2008年 / 198卷 / 02期

关键词：

human insulin; insulin aspart; perinatal outcomes; pregnancy; type; 1; diabetes; GLYCEMIC CONTROL; PRETERM DELIVERY; DOUBLE-BLIND; WOMEN; MORTALITY; MELLITUS; TRIAL; NATIONWIDE;

D O I：

10.1016/j.ajog.2007.08.005

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

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.

引用

页码：186.e1 / 186.e7

页数：7

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