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Clinical Trials/NCT04288037
NCT04288037
Unknown
N/A

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

University of Aarhus1 site in 1 country40 target enrollmentMay 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fetal Growth Retardation
Sponsor
University of Aarhus
Enrollment
40
Locations
1
Primary Endpoint
Low frequency power/High frequency power (LF/HF)
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Low frequency power/High frequency power (LF/HF)

Time Frame: 1/12-2020

Spectral analysis

Root mean square of successive inter beat interval differences RMSSD

Time Frame: 1/12-2020

Time domain analysis

Low frequency power (LF-power)

Time Frame: 1/12-2020

Spectral analysis

High frequency power (HF-power)

Time Frame: 1/12-2020

Spectral analysis

Standard deviation of normal to normal inter beat interval (SDNN)

Time Frame: 1/12-2020

Time domain analysis

Study Sites (1)

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