Study design, sample and setting
gestational diabetes, diabetes
GESTATIONAL DIABETES, RECRUITMENT, GESTATIONAL HYPERTENSION, HYPERTENSION, DIABETES
The registered FINNCARE study includes both a cross-sectional cohort study design performed at recruitment as well as the randomization of PE families into a behavioral lifestyle 12-month intervention (NCT04676295) [In total, 182 PE and 85 non-PE children consented to participate in the FINNCARE study. Exclusion criteria included ongoing maternal pregnancy or lactation, multiple pregnancy and inability to communicate in Finnish. For non-PE, exclusion criteria also included PE, gestational hypertension or chronic hypertension, gestational diabetes and/or diabetes during or following index pregnancy. To address potential recruitment bias, we compared backgrounds of participating and nonparticipating PE mothers from the Hospital district of Helsinki and Uusimaa FINNPEC cohort with no major differences observed (Table 1, Supplemental Digital Content 1).Study visits were arranged between June 2019 and June 2022 with 2:1 PE and non-PE families scheduled per visit in a tertiary care setting at the Clinical Trial Unit at Children's Hospital, Helsinki, Finland. Personnel performing study visits, collection and analyses of raw data were blinded to participant PE status. Participation was confirmed with a signed informed consent. The study protocol has approval by the Ethics Committee of the Hospital District of Helsinki and Uusimaa (HUS/3347/2018).