Mathiesen Elisabeth R, Andersen Henning, Kring Sofia I I, Damm Peter
Department of Endocrinology, Center for Pregnant Women with Diabetes, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, DK-2100, Copenhagen, Denmark.
Department of Obstetrics, Center for Pregnant Women with Diabetes, Rigshospitalet, Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
BMC Pregnancy Childbirth. 2017 Jan 18;17(1):38. doi: 10.1186/s12884-016-1177-4.
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.
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.
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.
ClinicalTrials.gov: NCT01892319 (date registered: 27.06.2013).
关于基础胰岛素类似物对糖尿病妊娠中先天性畸形和围产期死亡率等事件发生率的影响，目前缺乏相关数据。
本研究是一项在七个国家开展的前瞻性、非干预性、多中心队列研究，旨在评估妊娠期间地特胰岛素的安全性，并监测所分娩婴儿（子宫内暴露）至1岁时的健康状况。研究人群包括患有1型或2型糖尿病且正在接受胰岛素治疗的孕妇。数据将在常规医疗实践中收集。主要终点是接受地特胰岛素治疗的女性妊娠比例，与其他基础胰岛素治疗方案相比，这些妊娠未发生以下任何事件：严重先天性畸形、围产期死亡或新生儿死亡。计算得出样本量为3075例妊娠，以80%的检验效能在5%的显著性水平上检测组间主要终点的差异为3.5%。
该研究还将考察其他重要的母亲终点（如严重低血糖和先兆子痫的发生率）以及围产期结局，如新生儿超重，以及1岁时的婴儿结局。该研究有一个固定的招募期，从2013年至2018年，纳入所有符合条件的患者，预计可为未来糖尿病妊娠中基础胰岛素的处方提供参考依据。
ClinicalTrials.gov：NCT01892319（注册日期：2013年6月27日）。
