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Table 2 Key secondary outcomes

From: The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial

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

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

Perinatal loss:

Antepartum or intrapartum stillbirth

Neonatal death (early or late)

Death before neonatal discharge (after 28 days of birth)

Cause of death

  1. 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
  2. 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’
  3. bThese secondary outcomes will not be reported in the first clinical paper; please see the section on ‘Presentation and publication strategy’
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ISSN: 1745-6215