STV Analysis Versus Visual Evaluation of Cardiotocography in FGR (SAVEFGR)
Fetal Growth Retardation
About this trial
This is an interventional treatment trial for Fetal Growth Retardation focused on measuring fetal growth restriction, cardiotocography, perinatal death, short term variation
Eligibility 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 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. Exclusion Criteria: Known congenital or chromosomal anomalies influencing perinatal outcome. Imminent labour or expected maternal indication for delivery < 48 hours.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Visual interpretation of cardiotocography
Short term variation
Monitoring by visual interpretation of cardiotocography
Short term variation by computer software analysis