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OpenTrials
Completed

NCT Number: NCT04323865

Fetal Heart Rate Variability

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.

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Key information

Conditions

Fetal Growth Retardation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Arhus Universityhospital

Aarhus, Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy singleton pregnancies

Exclusion criteria

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

Treatment and study plan

fetal heart rate variability

Diagnostic Test

No direct intervention, as the study is observational.

Primary outcomes

  1. Standard deviation of normal to normal RR-interval (SDNN)

    Time frame: 01.04.2020

    Time domain analysis, measured in ms

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

    Time frame: 01.04.2020

    Time domain analysis, measured in ms

  3. Low frequency power (LF-power)

    Time frame: 01.04.2020

    Spectral analysis, measured in ms^2

  4. High frequency power (HF-power)

    Time frame: 01.04.2020

    Spectral analysis, measured in ms^2

  5. LF-power/HF-power

    Time frame: 01.04.2020

    Spectral analysis, ratio

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2020
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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