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Fetal Heart Rate Variability

Completed
Conditions
Fetal Growth Retardation
Interventions
Diagnostic Test: fetal heart rate variability
Registration Number
NCT04323865
Lead Sponsor
University of Aarhus
Brief Summary

Need statement

- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.

Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.

Aim of current study

- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
75
Inclusion Criteria

• Healthy singleton pregnancies

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Exclusion Criteria

• Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Study 2. Repeatability of FHRVfetal heart rate variability-
Primary Outcome Measures
NameTimeMethod
Standard deviation of normal to normal RR-interval (SDNN)01.04.2020

Time domain analysis, measured in ms

Root mean square of successive RR-interval differences (RMSSD)01.04.2020

Time domain analysis, measured in ms

LF-power/HF-power01.04.2020

Spectral analysis, ratio

Low frequency power (LF-power)01.04.2020

Spectral analysis, measured in ms\^2

High frequency power (HF-power)01.04.2020

Spectral analysis, measured in ms\^2

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Arhus Universityhospital

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Aarhus, Aarhus N, Denmark

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