STV Analysis Versus Visual Evaluation of Cardiotocography in FGR

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Known congenital or chromosomal anomalies influencing perinatal outcome.

Imminent labour or expected maternal indication for delivery < 48 hours.

Trial design

Treatments tested in this trial

  • Short term variation
  • Visual interpretation

Treatment groups

800 Participants
are divided into 2 treatment groups

Locations

This trial has no locations