(FHRV): Day to Day Variation in Fetal Heart Rate Variability
Sponsor
University of Aarhus (Other)
Overall Status
Unknown status
CT.gov ID
NCT04289350
Collaborator
Aarhus University Hospital (Other), Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation (Other), Hartmann Fonden (Other), Augustinus Fonden (Other), The Dagmar Marshall Foundation (Other), AP Moeller Foundation (Other)
45
1
22
2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study
Actual Study Start Date
:
Sep 1, 2018
Anticipated Primary Completion Date
:
Jul 1, 2020
Anticipated Study Completion Date
:
Jul 1, 2020
Outcome Measures
Primary Outcome Measures
- Root mean square of successive inter beat interval differences (RMSSD) [1/8-2020]
Time domain analysis
- Standard deviation of normal to normal inter beat interval (SDNN) [1/8-2020]
Time domain analysis
- High frequency power (HF-power) [1/8-2020]
Spectral analysis
- Low frequency power (LF-power) [1/8-2020]
spectral analysis
- Low frequency power/High frequency power (LF/HF) [1/8-2020]
Spectral analysis
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics and Gynecology. Aarhus Unive | Aarhus | Aarhus N | Denmark | 8200 |
Sponsors and Collaborators
- University of Aarhus
- Aarhus University Hospital
- Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
- Hartmann Fonden
- Augustinus Fonden
- The Dagmar Marshall Foundation
- AP Moeller Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04289350
Other Study ID Numbers:
- fHRV_2
First Posted:
Feb 28, 2020
Last Update Posted:
Feb 28, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: