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Clinical Trials/NCT04289350
NCT04289350
Completed
Not Applicable

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

University of Aarhus1 site in 1 country44 target enrollmentStarted: September 1, 2018Last updated:
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ConditionsFetal Growth Retardation

Overview

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Low frequency power (LF-power)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Low frequency power (LF-power)

Time Frame: 1/8-2020

spectral analysis

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

Time Frame: 1/8-2020

Time domain analysis

High frequency power (HF-power)

Time Frame: 1/8-2020

Spectral analysis

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

Time Frame: 1/8-2020

Spectral analysis

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

Time Frame: 1/8-2020

Time domain analysis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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