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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