Perinatal outcomes associated with the use of glargine during pregnancy.
OBJECTIVE
Insulin glargine (IG), with its non-peaking action profile, might be useful in diabetic pregnancy. However, data on its safety are limited and its use during pregnancy is not recommended. This study focused on the effects of IG on perinatal outcome, particularly to estimate the rate of congenital anomalies and birthweight.


METHODS
This retrospective study included women with pre-gestational diabetes who used IG before (at least 1 month) and during pregnancy. For all women we recorded data regarding maternal glycaemic control and pregnancy outcome. We also compared women treated with IG throughout pregnancy and women who stopped taking IG at an earlier stage.


RESULTS
From 27 centres, 107 Type 1 diabetic pregnancies were identified. IG was started 10.3 +/- 6.9 months before conception and in 57.4% of cases was stopped during the first trimester; 42.6% of women continued using it until the end of pregnancy. There were six abortions (four spontaneous and two induced) and five newborns (4.9%) with congenital anomalies. Glycaemic control, birthweight and the prevalence of macrosomia and neonatal morbidity were similar in women who used IG for the full term compared with those who stopped IG earlier during pregnancy.


CONCLUSIONS
This study, although limited, suggests that IG is safe and effective; the rate of congenital malformations was within the range expected for diabetic pregnancies treated with more traditional forms of insulin. IG used throughout pregnancy did not seem to influence birthweight or increase adverse outcomes.
Di Cianni
G
G
Department of Endocrinology and Metabolism, Section of Diabetes and Metabolic Diseases, University of Pisa, Pisa, Italy. dicianni@immr.med.unipi.it
Torlone
E
E
Lencioni
C
C
Bonomo
M
M
Di Benedetto
A
A
Napoli
A
A
Vitacolonna
E
E
Mannino
D
D
Lapolla
A
A
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000328:Adult; D001724:Birth Weight / Q000187:drug effects; D001786:Blood Glucose / Q000187:drug effects; D016022:Case-Control Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D005320:Fetal Macrosomia / Q000139:chemically induced; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D007226:Infant Mortality; D007231:Infant, Newborn; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives*; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D007558:Italy; D011247:Pregnancy; D011256:Pregnancy Outcome; D011254:Pregnancy in Diabetics / Q000188:drug therapy*; D012189:Retrospective Studies
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine