Table 2.
Key secondary outcomes
| Clinical outcomes | Health-economic outcomes | Process evaluation of implementation | ||
|---|---|---|---|---|
| Antenatal assessments | Neonatal outcomes | Maternal outcomes | ||
| Rate of antenatal ultrasound detection of SGA at birth by customised standards and by population references. Antenatal clinical detectiona of SGAb. Analysis of GAP diagnostic test performance (specificity, sensitivity, negative predictive value, positive predictive value)b Ultrasound assessment of SGA using a different threshold, e.g. 5th centileb. Growth trajectories (fetal biometry and EFW) and Doppler parameters in the detection of SGAb. Comparison of GROW ultrasound charts against standard population charts on classification of fetal growth (small for gestational age, appropriate for gestational age, large for gestational age)b |
Basic parameters: Gestational age at birth Birthweight Head circumference |
Antenatal: Length of stay in hospital |
Number of ultrasound scans after 24 weeks Antenatal clinic/antenatal day unit activity Rates of induction of labour Rates of caesarean sections Length of maternal and neonatal stay Admissions and average length of stay in NICU/SCBU |
Proportion of staff trained, staff assessed and women assessed with GAP programme Adherence to SGA risk stratification and management protocols Adherence to missed-case analysis Evaluation of acceptability and feasibility of intervention to staff and women, contextual barriers and facilitators, practice in control sites Organisational impact and unintended consequences |
| Condition at birth: 5-min Apgar score < 7 Arterial cord pH < 7.1 Any respiratory support given at delivery |
Intrapartum: Induction of labour Mode of delivery (including caesarean section rates) Postpartum haemorrhage Rates of 3rd or 4th degree perineal tear |
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| Neonatal admissions: Length of stay at each neonatal level of care | ||||
| Neonatal morbidity: Major neonatal morbidity (any of neonatal brain injury, receipt of supplemental oxygen at 28 days of age, Bell stage 2+ necrotising enterocolitis, culture-positive sepsis, retinopathy requiring ophthalmic intervention) Minor neonatal morbidity (any of: hypothermia, hypoglycaemia, nasogastric tube feeding) |
Postnatal: Length of stay in hospital Breastfeeding at discharge |
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| Perinatal loss: Antepartum or intrapartum stillbirth Neonatal death (early or late) Death before neonatal discharge (after 28 days of birth) Cause of death | ||||
Abbreviations: EFW estimated fetal weight, GAP Growth Assessment Protocol, GROW gestation-related optimal weight, NICU neonatal intensive care unit, SCBU special care baby unit, SGA small for gestational age
aClinical detection of SGA is defined as ‘antenatal acknowledgement that the foetus is expected to weigh below the 10th centile at birth, by charts appropriate to the study arm’
bThese secondary outcomes will not be reported in the first clinical paper; please see the section on ‘Presentation and publication strategy’