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Table 2 Outcomes, sampling and measurements

From: Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol

  Data collection points
  Method Sources Baseline During pregnancy Birth/postpartum
Primary Outcome
 LGAa scale SPRb    x
Secondary maternal outcomes
 Gestational Hypertension Blood pressure or ICD code SPRb/ eCRFf   x x
 Pre-eclampsia ICD code SPRb   x x
 Shoulder dystocia ICD code SPRb    x
 Induction of labour ICD code SPRb    x
 Emergency LSCS ICD code SPRb    x
 Elective LSCS ICD code SPRb    x
 Instrumental delivery ICD code SPRb    x
 Length of maternal stay from delivery to discharge hours, days SPRb    x
 Perineal trauma-3 and 4 degree ICD code SPRb    x
 Breastfeeding at hospital discharge Yes/no SPRb    x
 Maternal HbA1c (mmol/mol) Blood sample eCRFf x x  
 Self-reported health Scale 1–6 SPRb   x x
 Satisfaction with childbirth Scale 1–10 SPRb    x
 Post-part bleeding ml SPRb    x
 Gestational weight gain g or kg SPRb x x  
Secondary neonatal outcomes
 Stillbirth (≥22 + 0) ICD code SPRb/SNQc    x
 Neonatal death (< 28 days) ICD code SPRb /SCBd    x
 Erbs palsy ICD code SPRb/SNQc    x
 Metabolic acidosisg Umbilical artery and venous blood sample SPRb    x
 1,5,10 min Apgar score < 4 Clinical examination SPRb    x
 Hypoxic ischemic encephalopathy I-III ICD code SPRb/SNQe    x
 Intracranial haemorrhage ICD code SPRb/SNQe    x
 Meconium aspiration syndrome ICD code SPRb/SNQe    x
 Mechanical ventilation   SPRb/SNQe    x
 Fractured clavicle/humerus ICD code SPRb/SNQe    x
 Blood glucose in the infants (mmol/L) Blood sample eCFRf    x
 Preterm birth < 37, 34 or 32 weeks ICD code SPRb    x
 NICU date (xxxx/yy/zz) eCRFf    x
 NICU days days eCRFf/SPRb    x
 SGAh Calculated from birth weight / gestational age/gender SPRb    x
 Bilirubin (highest value) Blood sample eCRFf    x
 Phototherapy Medical record eCRFf    
 Hypoglycaemia needing IV therapy   eCRFf    x
Supplementary feeding
 Supplementary feeding indication Medical record eCFRf    x
 Interval (hours) and volume (ml) of supplementary feeding   eCFRf    x
 Product used   eCFRf    x
 Use of dextrose gel or intravenous treatment   eCFRf    x
  1. a Large for Gestational Age: Birth weight above the 90th percentile for gestational age in the Swedish reference population corrected for gestational age and gender
  2. b Swedish pregnancy register: Diagnosis based on ICD codes or values (ml, kg, g, numbers). Variable list available on https://www.medscinet.com/gr/forskare.aspx
  3. c The Swedish National Patient Register
  4. d Statistics Sweden
  5. e Swedish Neonatal Quality Register
  6. f eCFR.www.medscinet.com
  7. g pH < 7.05 and BE > 12 mmol/L or pH < 7.0
  8. h Birth weight < 10th percentile for gestational age, corrected for gestational age and gender. Swedish reference population