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. 2024 Apr 25;14(4):e082237. doi: 10.1136/bmjopen-2023-082237

Table 1.

Measures in the Danish Diabetes Birth Registry-2 for women during pregnancy

Timing Level of participation
Basic information Additional information
During pregnancy
Women Interview and data from medical records at 8–12 weeks:
Pre-pregnancy information:
History of disease:
Type of diabetes, diabetes duration, presence of diabetes-related comorbidities, history of gastric bypass/sleeve, other comorbidities, number of hypoglycaemic events that required assistance from others during the past year, hypoglycaemia awareness status.
Prior pregnancies:
Number of prior pregnancies, number of abortions, type and timing of abortions, year of delivery/abortion, term of prior pregnancies, birth weight of offspring, complications during prior pregnancies, mode of delivery prior pregnancies.
Pre-pregnancy use of insulin, diabetes technology and other medication:
Use of continuous glucose monitoring (CGM), type of sensor and upload platform in case of sensor use before or during pregnancy bolus advisor system use, insulin use, other medication, folic acid supplementation.
Insulin pump use before pregnancy, type and dose of insulin before pregnancy, carbohydrate ratio and sensitivity before pregnancy, type of insulin pump if used before pregnancy.
Pregnancy planning:
Data of stopping contraceptives, time of intending to get pregnant and getting pregnant, fertility treatment, pre-pregnancy counselling.
Pre-pregnancy information:
Pre-pregnancy height, pre-pregnancy weight, last HbA1c before pregnancy and date of assessment, last TSH, last vitamin D.
Background information:
Ethnicity, country of birth, household composition, level of education, employment status, alcohol use, smoking status, reading and/or writing problems, family history of diabetes.
Medical record—each pregnancy visits to the clinic:
Date of visit, HbA1c, current weight, blood pressure, urine ketone, urine albumin-creatinine ratio current use of insulin/sensor or bolus calculator, hypoglycaemic events (mild/severe), ketoacidosis, current use of other anti-glycaemic medication, eye examination.
Diabetes treatment:
Current insulin dose, insulin pump specifications and settings, number of finger pricks, CGM information (including uploads, mean glucose, time above range (>7.8 mmol/L), time in range (3.5–7.8 mmol/L), time below range (<3.5 mmol/L) in pregnancy.
Pregnancy complications:
Abortion and type, current comorbidities/treatments and date of onset (including hypertension, pre-eclampsia), use of lung maturing medication, premature rupture of membranes (including timing and result).
Ultrasound scans:
Crown-Rump-Length, head circumference (mm and z-score), abdominal circumference (mm and z-score), femur length (mm and z-score), estimated fetal weight (in grams based on Hadlock’s formula, z-score and in percentage deviation from expected for gestational age), amniotic fluid index and ‘deepest pocket’ in cm, uterine artery pulsatility (mean and z-score), umbilical artery pulsatility index (including z-score).
Biological samples at 12 and 28 weeks:
Genetic risk score, epigenetic markers, small RNAs, inflammatory cytokines, metabolic markers, placental markers, proteomics, serum and plasma for future biobank.
Questionnaire around 12 weeks of pregnancy:
Health status (SF-12, V.2),68 pregnancy symptoms hampering physical activity (SSQ), physical activity (PPAQ-DK),69 70 eating habits,71 diet (FFQ), changes in diet since pregnancy and supplement use (Danish national birth cohort),72 binge drinking episodes during pregnancy (Copenhagen Pregnancy Cohort),73 sleep (PSQI),74 history of psychopathology and psychotropic medication use (SSQs), history of contact with a psychologist/psychiatrist (SSQs), well-being (WHO-5),75 76 depression (EPDS),77 78 perceived stress (PSS),79 80 loneliness (T-ILS),81 diabetes-related distress (PAID),82 fear of hypoglycaemia (HFS-II-w),83 pregnancy worries (CWS),84 relationship duration (SSQ), marital satisfaction (SSQ), dyadic coping (DCI),85 health literacy (HLSAC),86 87 satisfaction with care (PACIC).88
Questionnaire at 26–29 weeks of pregnancy:
Health status (SF-12, V.2),68 changes in pregnancy symptoms hampering physical activity (SSQ), physical activity (PPAQ-DK),69 70 diet (FFQ), changes in diet since pregnancy and changes in supplement use (Danish national birth cohort),72 changes in binge drinking episodes during pregnancy (Copenhagen Pregnancy Cohort),73 sleep (PSQI),74 changes in psychopathology and psychotropic medication use (SSQ), changes in contact with a psychologist/psychiatrist (SSQ), well-being (WHO-5),75 76 depression (EPDS),77 78 perceived stress (PSS),79 80 loneliness (T-ILS),81 diabetes-related distress (PAID),82 fear of hypoglycaemia (HFS-II-w),83 pregnancy worries (CWS),84 breast feeding intention,89 prenatal attachment (MAAS),90 91 satisfaction with care (PACIC).92

CWS, Cambridge Worry Scale; DCI, Dyadic Coping Inventory (subscales: Stress communicated by oneself, supportive dyadic coping of the partner, delegated dyadic coping of the partner, negative dyadic coping by partner, common dyadic coping, evaluation of dyadic coping); EPDS, Edinburgh Postnatal Depression Scale; FFQ, Food Frequency Questionnaire; HbA1c, Hemoglobin A1c; HFS-II-w, Hypoglycaemia Fear Survey-II – worry subscale; HLCA, Health Literacy for School-Aged Children; MAAS, Maternal Antenatal Attachment Scale; PACIC, Patients Assessment Chronic Illness Care; PAID, Problem Areas in Diabetes; PAS-2=PPAQ-DK, Pregnancy Physical Activity Questionnaire; PSQI, Pittsburgh Sleep Quality Index; PSS, Perceived Stress Scale; SF12, 12 Item Short-Form (SF-12); SSQ, Study Specific Question; T-ILS, Three Item Loneliness Scale; TSH, Thyroid-stimulating hormone; WHO-5, WHO - Five Well-Being Index.