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 |