AIMS/HYPOTHESIS: To evaluate if the application of Lispro @entity2690 in pregnancy increases the risk for @entity600 or unusual pregnancy courses. METHODS: @entity6 specialists were contacted in Germany and Austria and asked to report @entity1 with @entity6 who had been treated with Lispro during pregnancy. Furthermore they were asked to report another pregnant @entity6 @entity1 treated with regular @entity2690 with similar @entity4051 c and age for each Lispro case. Following data were requested: age, first HbA1c in pregnancy and time of analysis, start and duration of Lispro treatment, ultrasound examination, chorionic villi biopsy, amniocentesis, unusual pregnancy courses, standard examination of the new-born for any @entity600 . Two-sided 95% confidence limits (95%-CI) for risk differences of proportions of @entity600 or unusual pregnancy courses were calculated. RESULTS: 33 pregnant @entity6 @entity1 with Lispro and 27 with regular @entity2690 treatment were analysed (mean age 28.3 years (17-41)and 30.1 (19-40); mean HbA1c 6.9% (4.5-10.7) and 6.8% (4.7-9.8), respectively). There were four @entity600 or unusual pregnancy course (spontaneous abortion; elective interruption because of multiple @entity600 ; @entity4297 and @entity8855 ; premature birth) in the Lispro and one @entity600 (dyplastic hip) in the regular @entity2690 group. Risk differences in proportions of @entity600 or unusual pregnancy courses were 8% (95%-CI: - 5% to 21%). CONCLUSIONS/INTERPRETATION: Risk differences for @entity600 or unusual pregnancy courses were not higher in the @entity2690 Lispro group compared to the controls. However, we observed four @entity600 or unusual pregnancy courses in the Lispro group. A case-control study is suggested to get a precise risk estimate.

XXXX Lispro in pregnancy--retrospective analysis of 33 cases and matched controls.

@entity1 :: ('9606', 'Species') :: ['women', 'woman'] @entity4051 :: ('3039', 'Gene') :: ['HbA1'] @entity6 :: ('MESH:D003920', 'Disease') :: ['Diabetes', 'diabetic', 'diabetes'] @entity8855 :: ('MESH:D006819', 'Disease') :: ['hyaline membrane syndrom'] @entity2690 :: ('3630', 'Gene') :: ['insulin'] @entity600 :: ('MESH:D000014', 'Disease') :: ['malformations', 'malformation'] @entity4297 :: ('MESH:D006330', 'Disease') :: ['heart malformations']
@entity2690 :: (3630,Gene) :: ['Insulin']
