Fetal Heart Rate Variability and Fetal Growth Restriction
(FGR)
Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study
1 other identifier
observational
40
1 country
1
Brief Summary
There is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. Furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction. This study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 23, 2020
February 1, 2020
1.6 years
February 20, 2020
November 20, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Root mean square of successive inter beat interval differences RMSSD
Time domain analysis
1/12-2020
Standard deviation of normal to normal inter beat interval (SDNN)
Time domain analysis
1/12-2020
Low frequency power (LF-power)
Spectral analysis
1/12-2020
High frequency power (HF-power)
Spectral analysis
1/12-2020
Low frequency power/High frequency power (LF/HF)
Spectral analysis
1/12-2020
Interventions
observational study. no intervention
Eligibility Criteria
Pregnant women expecting a small for gestational age child. Danish.
You may qualify if:
- singleton pregnant women with estimated fetal weight below 2 standard deviations (2SD) of mean for gestational age corresponding to minus 22%. Fetal weight assessed by doppler ultrasound.
You may not qualify if:
- Fetal malformations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundationcollaborator
- Hartmann Fondencollaborator
- Augustinus Fondencollaborator
- The Dagmar Marshall Foundationcollaborator
- AP Moeller Foundationcollaborator
Study Sites (1)
Arhus Universityhospital
Aarhus, Aarhus N, 8200, Denmark
Related Publications (1)
Zizzo AR, Hansen J, Peteren OB, Molgaard H, Uldbjerg N, Kirkegaard I. Growth-restricted human fetuses have preserved respiratory sinus arrhythmia but reduced heart rate variability estimates of vagal activity during quiescence. Physiol Rep. 2022 Nov;10(22):e15458. doi: 10.14814/phy2.15458.
PMID: 36411966DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 27, 2020
Study Start
May 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 23, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share