Fetal Heart Rate Variability

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

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.

Study Overview

• Status: Completed
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Diagnostic test: fetal heart rate variability

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Århus Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Danish. Healthy. Pregnant women. Expecting a healthy fetus.

Description

Inclusion Criteria:

• Healthy singleton pregnancies

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study 2. Repeatability of FHRV	Diagnostic test: fetal heart rate variability; No direct intervention, as the study is observational.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard deviation of normal to normal RR-interval (SDNN)	Time domain analysis, measured in ms	01.04.2020
Root mean square of successive RR-interval differences (RMSSD)	Time domain analysis, measured in ms	01.04.2020
Low frequency power (LF-power)	Spectral analysis, measured in ms^2	01.04.2020
High frequency power (HF-power)	Spectral analysis, measured in ms^2	01.04.2020
LF-power/HF-power	Spectral analysis, ratio	01.04.2020

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: fHRV_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No