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
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 |
Verified date | February 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Obstetrics and Gynecology. Aarhus Unive | Aarhus | Aarhus N |
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 |
Denmark,
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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