Fetal Growth RetardationNCT04323865
Fetal Heart Rate Variability
An observational study of Fetal Growth Retardation, run by University of Aarhus at 1 site in Denmark.
Trial summary
Need statement a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- fetal heart rate variability
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 1 Feb 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Danish. Healthy. Pregnant women. Expecting a healthy fetus.
Who may be able to join
- Healthy singleton pregnancies
Who cannot join
- Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses
Need statement
- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.
Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.
Aim of current study
- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in 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
No direct intervention, as the study is observational.
| Study group | Role | What they receive |
|---|---|---|
| Study 2. Repeatability of FHRV | Not described Receives: Diagnostic Test: fetal heart rate variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of normal to normal RR-interval (SDNN)
Time domain analysis, measured in ms
Measured: 01.04.2020
Root mean square of successive RR-interval differences (RMSSD)
Time domain analysis, measured in ms
Measured: 01.04.2020
Low frequency power (LF-power)
Spectral analysis, measured in ms^2
Measured: 01.04.2020
High frequency power (HF-power)
Spectral analysis, measured in ms^2
Measured: 01.04.2020
LF-power/HF-power
Spectral analysis, ratio
Measured: 01.04.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Jun 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
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, Aalborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323865
- Sponsor's protocol ID
- fHRV_1
- 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
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
- Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses
- ClinicalTrials.gov ID
- NCT04323865
- Acronym / sponsor ID
- fHRV_1
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- 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, Aalborg University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 27 Mar 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.
Need statement
- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.
Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.
Aim of current study
- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study 2. Repeatability of FHRV | – | Diagnostic Test: fetal heart rate variability |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Danish. Healthy. Pregnant women. Expecting a healthy fetus.
Key inclusion criteria (1 listed)
- Healthy singleton pregnancies
Key exclusion criteria (1 listed)
- Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
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 variabilityNo direct intervention, as the study is observational. | Diagnostic test | Study 2. Repeatability of FHRV |
Primary outcome
Standard deviation of normal to normal RR-interval (SDNN)
Time frame: 01.04.2020
Time domain analysis, measured in ms
Root mean square of successive RR-interval differences (RMSSD)
Time frame: 01.04.2020
Time domain analysis, measured in ms
Low frequency power (LF-power)
Time frame: 01.04.2020
Spectral analysis, measured in ms^2
High frequency power (HF-power)
Time frame: 01.04.2020
Spectral analysis, measured in ms^2
LF-power/HF-power
Time frame: 01.04.2020
Spectral analysis, ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: No
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Intrauterine Fetal Growth Restriction and Fetuin-B
IUGR
RecruitingObservational study
Assessment of Invasive Genetic Testing in Fetuses With Isolated Intrauterine Growth Restriction Diagnosed After 28 Weeks of Gestation at Strasbourg University Hospitals (2016-2023)
Isolated Intrauterine Growth Restriction (IUGR)
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.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation of normal to normal RR-interval (SDNN) (time frame: 01.04.2020). 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?
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.