Fetal Heart Rate Variability and Fetal Growth Restriction

Fetal Growth Retardation Clinical Trial

— (FGR)  

Official title:

Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288037
• Other study ID #: fHRV_3
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2020
• Source: University of Aarhus
• Contact: Anne Rahbek Zizzo, MD
• Phone: +45 7845 3325
• Email: arz[@]clin.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. Furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction.

This study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• singleton pregnant women with estimated fetal weight below 2 standard deviations (2SD) of mean for gestational age corresponding to minus 22%. Fetal weight assessed by doppler ultrasound.

Exclusion Criteria:

• Fetal malformations

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Diagnostic Test:
• fetal heart rate variability
observational study. no intervention

Locations

Country	Name	City	State
Denmark	Arhus Universityhospital	Aarhus	Aarhus N

Sponsors (7)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, AP Moeller Foundation, Augustinus Fonden, Brødrene Hartmanns Fond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, The Dagmar Marshall Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root mean square of successive inter beat interval differences RMSSD	Time domain analysis	1/12-2020
Primary	Standard deviation of normal to normal inter beat interval (SDNN)	Time domain analysis	1/12-2020
Primary	Low frequency power (LF-power)	Spectral analysis	1/12-2020
Primary	High frequency power (HF-power)	Spectral analysis	1/12-2020
Primary	Low frequency power/High frequency power (LF/HF)	Spectral analysis	1/12-2020