We identified all women who had ≥1 hospitalization for a delivery after SLE diagnosis using Quebec's physician billing and hospitalization databases (1989 to 2009). Women were defined as SLE cases if they had any of the following: ≥1 hospitalization with a diagnosis of SLE prior to the delivery; a diagnosis of SLE recorded at the time of their hospitalization for delivery; or ≥2 physician visits with a diagnosis of SLE, occurring 2 to 24 months apart, prior to the delivery. We randomly selected a general population control group, composed of women matched at least 4:1 for age and year of delivery, who did not have a diagnosis of SLE prior to or at the time of delivery. We identified children born live to SLE cases and their matched controls, and obtained information on all physician visits and hospitalizations incurred by these children. We ascertained major congenital anomalies, as defined by ≥1 hospitalization or physician visit with an ICD-9/10 diagnostic code for major congenital anomaly, within the first 12 months of life. We performed multivariate analyses to adjust for maternal demographics (that is, age, education, marital status), sex and birth order of child, major maternal co-morbidities (that is, pre-gestational diabetes, hypertension, asthma, depression), and relevant maternal medications (that is, antimalarials, corticosteroids, immunosuppressants).