Development and evaluation of a standardized registry for diabetes in pregnancy using data from the Northern, North West and East Anglia regional audits.

Objectives To develop and evaluate a standardized data set for measuring pregnancy outcomes in women with Type 1 and Type 2 diabetes and to compare recent outcomes with those of the 2002-2003 Confidential Enquiry into Maternal and Child Health. Methods Existing regional, national and international data sets were compared for content, consistency and validity to develop a standardized data set for diabetes in pregnancy of 46 key clinical items. The data set was tested retrospectively using data from 2007-2008 pregnancies included in three regional audits (Northern, North West and East Anglia). Obstetric and neonatal outcomes of pregnancies resulting in a stillbirth or live birth were compared with those from the same regions during 2002-2003. Results Details of 1381 pregnancies, 812 (58.9%) in women with Type 1 diabetes and 556 (40.3%) in women with Type 2 diabetes, were available to test the proposed standardized data set. Of the 46 data items proposed, only 16 (34.8%), predominantly the delivery and neonatal items, achieved ≥ 85% completeness. Ethnic group data were available for 746 (54.0%) pregnancies and BMI for 627 (46.5%) pregnancies. Glycaemic control data were most complete-available for 1217 pregnancies (88.1%), during the first trimester. Only 239women (19.9%) had adequate pregnancy preparation, defined as preconception folic acid and first trimester HbA1c ≤ 7% (≤ 53 mmol/mol). Serious adverse outcome rates (major malformation and perinatal mortality) were 55/1000 and had not improved since 2002-2003. Conclusions Astandardized data set for diabetes in pregnancymay improve consistency of data collection and allow formore meaningful evaluation of pregnancy outcomes in women with pregestational diabetes. [ABSTRACT FROM AUTHOR]