Fetal Heart Rate Variability

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323865
• Other study ID #: fHRV_1
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy singleton pregnancies

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Diagnostic Test:
• fetal heart rate variability
No direct intervention, as the study is observational.

Locations

Country	Name	City	State
Denmark	Arhus Universityhospital	Aarhus	Aarhus N

Sponsors (8)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University, Aarhus University Hospital, AP Moeller Foundation, Augustinus Fonden, Brødrene Hartmanns Fond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, The Dagmar Marshall Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

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