Ireland
--:--IST
Recruiting Not applicable

STV Analysis Versus Visual Evaluation of Cardiotocography in FGR

NCT06010238 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2025-06-18
Last updated
2026-11-04

Condition(s) studied

Fetal Growth Retardation

Investigational drug(s) / intervention(s)

Short term variationVisual interpretation

Short term variation: Short term variation in computer software analysis

Visual interpretation: Visual interpretation of cardiotocography

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of pregnancies resulting in perinatal death — Before discharge from neonatal intensive care unit (NICU), up to 1 year
    Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU

Trial sites (6)

FacilityCityRegionStatus
University Medical Center Groningen Groningen Provincie Groningen Recruiting
Amsterdam University Medical Center Amsterdam Netherlands Not Yet Recruiting
Maastricht University Medical Center+ Maastricht Netherlands Not Yet Recruiting
Radboud University Medical Center Nijmegen Netherlands Not Yet Recruiting
Erasmus MC University Medical Center Rotterdam Netherlands Not Yet Recruiting
Isala Zwolle Netherlands Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06010238 on ClinicalTrials.gov ↗ ← All trials in the Netherlands