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NCT04289350 Clinical Trial

Day to Day Variation in Fetal Heart Rate Variability

Fetal Growth Retardation Clinical Trial

— (FHRV)  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04289350
Other study ID # fHRV_2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date July 1, 2020

Study information
Verified date February 2020
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• fetal heart rate variability
An observational study. No intervention

Locations
Country Name City State
Denmark Department of Obstetrics and Gynecology. Aarhus Unive Aarhus Aarhus N

Sponsors (7)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, AP Moeller Foundation, Augustinus Fonden, Hartmann Fonden, 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 Root mean square of successive inter beat interval differences (RMSSD) Time domain analysis 1/8-2020
Primary Standard deviation of normal to normal inter beat interval (SDNN) Time domain analysis 1/8-2020
Primary High frequency power (HF-power) Spectral analysis 1/8-2020
Primary Low frequency power (LF-power) spectral analysis 1/8-2020
Primary Low frequency power/High frequency power (LF/HF) Spectral analysis 1/8-2020
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