Fetal Growth Retardation(FGR)NCT04288037
Fetal Heart Rate Variability and Fetal Growth Restriction
An observational study of Fetal Growth Retardation, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- fetal heart rate variability
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: Pregnant women expecting a small for gestational age child. Danish.
Who may be able to join
- 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.
Who cannot join
- Fetal malformations
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Arhus Universityhospital
Aarhus, Aarhus N, 8200
Niels Uldbjerg, +45 7845 3325, uldbjerg@clin.au.dk
About this study
Official title: Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study
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.
- Conditions
- Fetal Growth Retardation
- Being tested
- fetal heart rate variability
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal heart rate variabilityDiagnostic test
observational study. no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Root mean square of successive inter beat interval differences RMSSD
Time domain analysis
Measured: 1/12-2020
Standard deviation of normal to normal inter beat interval (SDNN)
Time domain analysis
Measured: 1/12-2020
Low frequency power (LF-power)
Spectral analysis
Measured: 1/12-2020
High frequency power (HF-power)
Spectral analysis
Measured: 1/12-2020
Low frequency power/High frequency power (LF/HF)
Spectral analysis
Measured: 1/12-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 May 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, Hartmann Fonden, Augustinus Fonden, The Dagmar Marshall Foundation, AP Moeller Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288037
- Sponsor's protocol ID
- fHRV_3
- Acronym
- (FGR)
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36411966
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study
- ClinicalTrials.gov ID
- NCT04288037
- Acronym / sponsor ID
- (FGR) / fHRV_3
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, Hartmann Fonden, Augustinus Fonden, The Dagmar Marshall Foundation, AP Moeller Foundation
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women expecting a small for gestational age child. Danish.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Fetal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fetal heart rate variabilityobservational study. no intervention | Diagnostic test | – |
Primary outcome
Root mean square of successive inter beat interval differences RMSSD
Time frame: 1/12-2020
Time domain analysis
Standard deviation of normal to normal inter beat interval (SDNN)
Time frame: 1/12-2020
Time domain analysis
Low frequency power (LF-power)
Time frame: 1/12-2020
Spectral analysis
High frequency power (HF-power)
Time frame: 1/12-2020
Spectral analysis
Low frequency power/High frequency power (LF/HF)
Time frame: 1/12-2020
Spectral analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Derived from this study: PubMed 36411966Zizzo 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.
- Individual participant dataSharing planned: No
Related trials for Fetal Growth Retardation
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Rahbek Zizzo, MD (+45 7845 3325, arz@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root mean square of successive inter beat interval differences RMSSD (time frame: 1/12-2020). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.