fetal growth restriction impaired growth of the unborn baby
Conditions
Interventions
-Visual interpretation of cardiotocography.
-Short term variation analysis in computerized cardiotocography.
Sponsors
Amsterdam UMC
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 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 as biometric ultrasound measurement of the abdominal circumference OR a combination of measurements resulting in an estimated fetal weight below the 10th percentile AND umbilical artery Doppler pulsatility index >p95. - Maternal age >= 16 years. - written informed consent
Exclusion criteria
Exclusion criteria: - Known congenital or chromosomal anomalies influencing perinatal outcome. - Imminent labour or expected maternal indication for delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is perinatal death, defined as antenatal death or neonatal/infant death before discharge from NICU. Our hypothesis is that in the pregnant women monitored by STV in cCTG, a decrease in the primary outcome will be observed, compared with pregnant women monitored by visual interpretation of CTG. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Major neonatal morbidity until discharge home. 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. •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. •Neurodevelopmental impairment, defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age, where available by local protocol. •ASQ, physical growth and Lexilijst, in addition to neurodevelopmental outcome measures. •Delivery characteristics including Apgar scores and umbilical cord pH. •All remaining outcomes required by the core outcome set for fetal growth restriction will also be collected. •Serum biomarkers and fetal electrocardiography, when available. | — |
Countries
Belgium, Denmark, Netherlands, Poland
Contacts
Public ContactJ.W. Ganzevoort
Amsterdam UMC
Outcome results
None listed