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NCT04288037 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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
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