STV analysis for fetal monitoring in severe early FGR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a stepped wedge cluster randomized trial in pregnant women with severe, early-onset fetal growth restriction (before 32 weeks). It compares STV-analysis based CTG monitoring to standard visual interpretation of cardiotocography. The intervention aims to reduce fetal hypoxia-related complications by providing a potentially more reliable signal of fetal well-being. The study uses a cluster-randomized design across participating hospitals to gradually switch from standard care to STV-assisted monitoring. Enrollment targets are singletons aged 18 and older, with specific biometric or Doppler criteria defining FGR, and excluding cases with known anomalies or imminent delivery within 48 hours.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Medical Center Groningen
  Groningen, Provincie Groningen, Netherlands 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

Study contacts

• Principal investigator: Wessel Ganzevoort, MD PhD — Amsterdam UMC
• Study coordinator: Wessel Ganzevoort, MD PhD
• Email: j.w.ganzevoort@amsterdamumc.nl
• Phone: 003120-5669111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.