Fetal Growth Retardation(FHRV)NCT04289350
Day to Day Variation in Fetal Heart Rate Variability
An observational study of Fetal Growth Retardation, run by University of Aarhus at 1 site in Denmark.
Trial 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. 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
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 1 Jul 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: Healthy singleton pregnant women. Danish.
Who may be able to join
- Healthy singleton pregnant women with an expected healthy fetus
Who cannot join
- fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Obstetrics and Gynecology. Aarhus Unive
Aarhus, Aarhus N, 8200
About this study
Official title: Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study
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.
- 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
An 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: 1/8-2020
Standard deviation of normal to normal inter beat interval (SDNN)
Time domain analysis
Measured: 1/8-2020
High frequency power (HF-power)
Spectral analysis
Measured: 1/8-2020
Low frequency power (LF-power)
spectral analysis
Measured: 1/8-2020
Low frequency power/High frequency power (LF/HF)
Spectral analysis
Measured: 1/8-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Sep 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 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.
- 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
- 44 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289350
- Sponsor's protocol ID
- fHRV_2
- Acronym
- (FHRV)
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 2 Nov 2022
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study
- ClinicalTrials.gov ID
- NCT04289350
- Acronym / sponsor ID
- (FHRV) / fHRV_2
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 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
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 28 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy singleton pregnant women. Danish.
Key inclusion criteria (1 listed)
- Healthy singleton pregnant women with an expected healthy fetus
Key exclusion criteria (1 listed)
- fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.
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 variabilityAn observational study. No intervention | Diagnostic test | – |
Primary outcome
Root mean square of successive inter beat interval differences (RMSSD)
Time frame: 1/8-2020
Time domain analysis
Standard deviation of normal to normal inter beat interval (SDNN)
Time frame: 1/8-2020
Time domain analysis
High frequency power (HF-power)
Time frame: 1/8-2020
Spectral analysis
Low frequency power (LF-power)
Time frame: 1/8-2020
spectral analysis
Low frequency power/High frequency power (LF/HF)
Time frame: 1/8-2020
Spectral analysis
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 2 Nov 2022.
- Individual participant dataSharing planned: No
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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 2 Nov 2022. 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?
Root mean square of successive inter beat interval differences (RMSSD) (time frame: 1/8-2020). 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 2 Nov 2022.