This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.
Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.
Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95.
Maternal age ≥ 18 years.
Able to provide written informed consent for collection and use of data on informed consent form in available language.
Known congenital or chromosomal anomalies influencing perinatal outcome.
Imminent labour or expected maternal indication for delivery < 48 hours.
Parallel
Short term variation
DeviceShort term variation in computer software analysis
Visual interpretation
DeviceVisual interpretation of cardiotocography
Proportion of pregnancies resulting in perinatal death
Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU
Proportion of children with major neonatal morbidity
Major neonatal morbidity is a composite outcome defined as intraventricular hemorrhage grade 3 or more, periventricular leukomalacia grade 2 or more, moderate or severe bronchopulmonary dysplasia, necrotizing enterocolitis Bell stage 2 or more, or retinopathy of prematurity requiring therapy.
Proportion of children with neonatal morbidities
Individual neonatal morbidities of the abovementioned composite outcome and additionally persisting ductus arteriosus, persistent pulmonary hypertension of the newborn (PPHN), respiratory distress syndrome (RDS), period of invasive mechanical ventilation in days, medication need, hypoglycaemia, neonatal jaundice, sepsis and cardiovascular function.
Proportion of children with neurodevelopmental impairment
Neurodevelopmental impairment is defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score \< 85, composite motor score \< 85), cerebral palsy, with a Gross Motor Function Classification System (GMFCS) grade \> 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age
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