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Fetal Heart Rate Variability

Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04323865
Enrollment
75
Registered
2020-03-27
Start date
2018-06-01
Completion date
2020-02-01
Last updated
2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Retardation

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.

Interventions

No direct intervention, as the study is observational.

Sponsors

Aarhus University Hospital
CollaboratorOTHER
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
CollaboratorOTHER
Hartmann Fonden
CollaboratorOTHER
Augustinus Fonden
CollaboratorOTHER
The Dagmar Marshall Foundation
CollaboratorOTHER
AP Moeller Foundation
CollaboratorOTHER
Aalborg University
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

• Healthy singleton pregnancies

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Standard deviation of normal to normal RR-interval (SDNN)01.04.2020Time domain analysis, measured in ms
Root mean square of successive RR-interval differences (RMSSD)01.04.2020Time domain analysis, measured in ms
Low frequency power (LF-power)01.04.2020Spectral analysis, measured in ms\^2
High frequency power (HF-power)01.04.2020Spectral analysis, measured in ms\^2
LF-power/HF-power01.04.2020Spectral analysis, ratio

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026