SAVE FGR STUDY MATERIAL

On this page you will find all important links to essential study materials of the SAVE FGR study.

Summary

SAVE FGR is a multicenter stepped wedge cluster randomized clinical trial in women with singleton pregnancies between 24 and 32 weeks of gestation with eoFGR (abdominal circumference or estimated fetal weight <p10 AND umbilical artery pulsatility index >p95) with an indication for fetal monitoring by CTG and delivery at signs of hypoxia.

In the control period of each center, fetal monitoring by CTG is done with visual evaluation of the CTG. In the intervention period, visual evaluation is supported by STV analysis of the CTG, and delivery indicated if the STV is <3.5 ms (<29 weeks gestation) or <4.0 ms (29-32 weeks gestation).

Recruiting centers will be in the Netherlands, Belgium and Denmark, with an intended sample size of 800 participants.

Primary outcomes are perinatal death and neurodevelopmental impairment at two years of corrected age, based on the Ages and Stages Questionnaire. Secondary outcome measures include delivery characteristics, maternal health, neonatal morbidity and neurodevelopmental impairment assessed until two years of corrected age.

This study will provide insight if the STV in the timing of delivery in fetus with pregnancies complicated by eoFGR improves both perinatal and neurodevelopmental outcomes until two years of corrected age.

Study Protocol

[available as soon as published]

Patient Information and Informed Consent Form

English

Trial:

Biobank:

 

Dutch

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French

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Danish

Trial:

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Practical Protocol

Please find the practical protocol for an overview of the study aims and study procedures.

practical-protocol-save-fgr-v1.7-11102024

Study Links

Castor eCRF:

Castor manual:

Animation Videos

English

Dutch

French

Danish

Doppler Learning