Study Subjects
calculus, GDM
GDM, SYNDROME, GESTATIONAL DIABETES MELLITUS
This was a prospective follow-up study in the offspring of 2 previously published Finnish randomized controlled trials with similar study designs,Participants of the 2 original randomized controlled trials and those of the 9-year follow-up study. †Of the 110 participants, who completed the original study in the metformin group in Turku, 3 offspring were excluded because 1 child had valproate syndrome, 1 child had down syndrome, and 1 child was stillborn. In the 9-year follow-up of 82 participants in the metformin group, 2 children were excluded (Swedish language), and for 2 children, a psychologist was not available for testing. ¤Of the 90 participants in the insulin group, 7 children were excluded because 1 child had attended a psychological test within less than a year, 8 children had Swedish as a school language, and for 1 child, a psychologist was not available for testing. BRIEF, Behavioral Rating Inventory of Executive Functioning; GDM, gestational diabetes mellitus; LUKILASSE, Screening test for reading, writing, and calculus for first to sixth grades; NEPSY II, developmental neuropsychological assessment test; TMT, Trail Making Test; WISC, Wechsler Intelligence Scale for Children.This 9-year follow-up study was conducted at 2 sites, Turku University Hospital in Southwest Finland and Oulu University Hospital in Northern Finland, between 2015 and 2019. Examination included measurements of growth, body composition, and blood tests for metabolism, and these results were reported previously.Written informed consent was obtained from each mother, child, and father. The assessors were blinded to the treatment allocation of the mothers. The 9-year follow-up study was registered with the Clinical Trials Registry (NCT02417090) and approved by the Ethics Committee of the Hospital District of Southwest Finland (ETMK 31/2015, April 27, 2015).