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Table 1 Definitions of key terms

From: 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

Term Definition
Congenital malformation A morphological defect of an organ, part of an organ or larger region of the body resulting from an intrinsically abnormal developmental process
Foetal macrosomia Birth weight above 4 kg
Large for gestational age Live born infant with birth weight >90th percentile for gestational age and sex according to local reference
Major malformation A life-threatening structural anomaly or an abnormality likely to cause significant impairment of health or functional capacity and which needs medical or surgical treatment; examples are abnormalities likely to lead to serious handicap or likely to lead to major cosmetic defects (e.g., cleft lip) and which may require major surgery to repair (e.g., atrial septal defect or ventricular septal defect)
Major hypoglycaemia A hypoglycaemic episode in which the patient is not able to treat themselves and in which oral carbohydrates, glucagon or intravenous glucose has to be administered to the patient by another person because of severe central nervous system dysfunction
Neonatal death Death of an infant between 7 and 28 completed days after delivery
Perinatal death Death of a foetus/infant at ≥22 completed gestational weeks and <1 completed week after delivery
Preterm delivery Delivery before 37 completed gestational weeks
Pre-eclampsia A condition in pregnancy characterised by new onset of abrupt hypertension (≥140/90 mmHg documented on two occasions, ≥6 h and ≤7 days apart) and proteinuria/albuminuria
Spontaneous abortion A naturally occurring termination of a pregnancy before 22 completed gestation weeks