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OpenTrials
Completed

NCT Number: NCT04289350

Day to Day Variation in Fetal Heart Rate Variability

This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.

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Key information

Who can participate

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

Inclusion criteria

  • Healthy singleton pregnant women with an expected healthy fetus

Exclusion criteria

  • fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.

Treatment and study plan

fetal heart rate variability

Diagnostic Test

An observational study. No intervention

Primary outcomes

  1. Root mean square of successive inter beat interval differences (RMSSD)

    Time frame: 1/8-2020

    Time domain analysis

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

    Time frame: 1/8-2020

    Time domain analysis

  3. High frequency power (HF-power)

    Time frame: 1/8-2020

    Spectral analysis

  4. Low frequency power (LF-power)

    Time frame: 1/8-2020

    spectral analysis

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

    Time frame: 1/8-2020

    Spectral analysis

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study

Acronym: (FHRV)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2020
Registry last updated
Nov 2, 2022

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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