Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins
| Autor: | Sofia I. I. Kring, Henning F. Andersen, Peter Damm, Elisabeth R. Mathiesen |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty medicine.medical_treatment Perinatal Death Insulin Detemir/adverse effects Pregnancy in Diabetics 030209 endocrinology & metabolism Type 2 diabetes Diabetes Mellitus/drug therapy Hypoglycemic Agents/adverse effects Pregnancy in Diabetics/drug therapy 03 medical and health sciences Study Protocol 0302 clinical medicine Insulin Detemir Pregnancy Diabetes mellitus Obstetrics and Gynaecology medicine Diabetes Mellitus Abnormalities Drug-Induced/epidemiology Humans Hypoglycemic Agents 030212 general & internal medicine Prospective Studies Prospective cohort study Insulin detemir Obstetrics business.industry Insulin Diabetes Infant Newborn Obstetrics and Gynecology Abnormalities Drug-Induced medicine.disease Basal (medicine) Research Design Perinatal Death/etiology Female business Cohort study medicine.drug |
| Zdroj: | BMC Pregnancy and Childbirth Mathiesen, E R, Andersen, H, Kring, S I I & Damm, P 2017, ' Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins ', BMC Pregnancy and Childbirth, vol. 17, 38 . https://doi.org/10.1186/s12884-016-1177-4 Mathiesen, E R, Andersen, H, Kring, S I I & Damm, P 2017, ' Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins ', BMC Pregnancy and Childbirth, vol. 17, no. 1, pp. 38 . https://doi.org/10.1186/s12884-016-1177-4 |
| ISSN: | 1471-2393 |
| Popis: | Background There are a lack of data regarding the effect of basal insulin analogues on rates of events like congenital malformation and perinatal mortality in diabetic pregnancy. Methods The present study is a prospective, non-interventional, multicentre cohort study conducted in seven countries, designed to assess the safety of insulin detemir during pregnancy, and to monitor the health status of resulting infants (exposed in utero) up to 1 year of age. The study population includes women with type 1 or type 2 diabetes, who are pregnant and being treated with insulin. Data will be collected in the context of routine practice. The primary endpoint is the proportion of pregnancies in women treated with insulin detemir, compared with other basal insulin regimens, which do not result in any of the following events: major congenital malformations, perinatal death or neonatal death. A sample size of 3075 pregnancies was calculated to provide an 80% power to detect a difference of 3.5% between groups in the primary endpoint at a 5% level. Discussion The study will also examine other important maternal endpoints (e.g., incidences of severe hypoglycaemia and pre-eclampsia) and perinatal outcomes such as overweight neonates, as well as infant outcomes at 1 year of age. It has a fixed recruitment period from 2013 to 2018, enrolling all eligible patients, and is expected to inform future prescribing with basal insulins in diabetic pregnancy. Trial registration ClinicalTrials.gov: NCT01892319 (date registered: 27.06.2013). Electronic supplementary material The online version of this article (doi:10.1186/s12884-016-1177-4) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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