Materials and methods
macrosomia, weight gain, GDM
EVENTS, RECRUITMENT, GDM, SECONDARY, NEONATAL HYPOGLYCAEMIA, HYPERGLYCAEMIA
We performed a non-blinded, randomised controlled trial between March 2020 and October 2022, that recruited 100 pregnant women diagnosed with GDM between 24 and 28 weeks of gestation at the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw. A diagnosis of GDM was based on 2013 World Health Organisation criteria: (1) fasting plasma glucose 92–125 mg/dl (2) 1-h glucose concentration ≥ 180 mg/dl or (3) 2-h glucose concentration 153–199 mg/dl [After meeting the inclusion criteria patients were randomly allocated with a nested qualitative evaluation and 1:1 allocation ratio to the study (Study consisted of five visits, including recruitment and four follow-up visits. At the first visit all study participants were informed about glycaemic control, diet recommendations and physical activity. During the three follow up visits (2 weeks, 4 weeks after the recruitment visit and between 34–36 weeks of gestation) clinical and laboratory results were assessed, including: fasting and 1 h-postprandial glucose concentrations (after breakfast, lunch, and dinner), qualification to insulin therapy and dosage, diet control, physical activity and gestational weight gain. The qualification to insulin therapy was decided in case of hyperglycaemia, defined as fasting glycaemia ≥ 90 mg/dl or 1 h-postprandial glycaemia ≥ 140 mg/dl. At the second and third follow up visits Haemoglobin A1c (HbA1c) concentration and ultrasound estimated fetal weight (EFW) were measured. For the assessment of fetal birthweight percentile INTERGROWTH-21st Chart was implemented. At the last follow up visit (Visit 5; postpartum) patients were reviewed for perinatal outcomes: weeks of gestation and route of birth, newborn weight and neonatal hypoglycaemic events.As part of our study we analysed physical activity by daily footsteps measure with step counter app. After calculating daily steps, we divided participants into 4 groups–sedentary: < 5000; low active: 5000–7500; somewhat active: 7500–10,000 or active: > 10,000 steps.We also evaluated patient’s dietary habits and its modifications throughout pregnancy by using Eating Assessment Test (EAT) prepared by the Polish National Institute of Public Health–National Institute of Hygiene (Supplementary File 1). EAT contained a short questionnaire, with 20 items for diet assessment. Based on EAT, participants were assigned to one of four diet groups: good: 39–42; satisfactory: 30–38; demanding diet modification: 12–29 and not satisfactory: < 12 points.The primary outcome of the study was mean fasting and 1 h postprandial glycaemia during the first 28 days following GDM diagnosis. Additionally, we analysed variability pattern of glucose concentration inside the groups by using delta mean fasting and postprandial glucose concentration for each group, defined as difference between 3rd to 4th week mean glycaemia and 1st to 2nd week mean glycaemia. The secondary outcomes were maternal and neonatal outcomes, including: qualification to insulin therapy, insulin dosage, hypoglycaemic episodes (defined as glycaemia < 70 mg/dl), HbA1c concentration, pregnancy weight gain, physical activity and diet modifications, fetal birthweight and percentile, incidence of fetal macrosomia and neonatal hypoglycaemia.The detailed study protocol was already published in 2020 [