Fetal Heart Rate VariabilityFETUSESNCT02835417
Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES)
An observational study of Fetal Heart Rate Variability, run by Hospices Civils de Lyon.
Trial summary
Background The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis. FHR variability is traditionally investigated using Fourier transform, however, fetal conditions differ from adults (higher frequency, widely instable signal) modifying spectrum repartition along frequencies… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Heart Rate Variability
- How many people
- 3,563 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2013
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All fetuses with STAN surveillance during labor.
Who may be able to join
None listed.
Who cannot join
- Women with recirdin lasting less than 60 minutes, with more than 20 % of missing data, or more than 20 minutes between the end of recording and birth.
About this study
Background
The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis. FHR variability is traditionally investigated using Fourier transform, however, fetal conditions differ from adults (higher frequency, widely instable signal) modifying spectrum repartition along frequencies, making this approach inappropriate. New mathematic approach, including Multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor based wavelet entropy rate measures, scattering transform, may identify parameters associated with fetal acidosis. Modern classification system, driven by the data, based on these relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the clinician in decision making for the management and termination of labor. Analysing 20 to 30 minutes sliding windows with these different methods in a limited number of cases (foetus born with acidosis) and controls (foetus without acidosis) should lead to identify relevant parameters, which will be submitted to these classification tools. For external validation, a large database, including more than 4500 FHR recording documented with foetal outcomes, will be used to evaluate the performance of the combination of parameters identify and classification system used to discriminate foetuses at risk for short term acidosis or not, in order to give a relevant information to the clinician before acidosis occurs, to make the appropriate decision.
- Conditions
- Fetal Heart Rate Variability
- Keywords
- fetal heart rate variability, entropy, multifractal analysis, scattering transform, sparse vector machine, acidosis
- Medical subject headings
- Acidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hurst parameter comes from multifractal analysis
Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.
Measured: Day 0 (during 20 to 30 minutes sliding windows during labor)
P-leader comes from multifractal analysis
Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.
Measured: Day 0 (during 20 to 30 minutes sliding windows during labor)
Secondary outcomes (4)
Scattering transform
The scattering transform is a nonlinear extension of the underlying wavelet transform used for multifractal analysis and is another way to quantify fetal heart rate variability
Measured: Day 0 (during 20 to 30 minutes sliding windows during labor)
Entropy rate
A k-nearest neighbor procedure yields estimates for entropy rates is another method to quantify fetal heart rate variability
Measured: Day 0 (during 20 to 30 minutes sliding windows during labor)
adaptative multiscale complexity analysis
THE FHR signal is separated in the lower number of lines to fullfile the whole signal. The number and longer of segment is data driven, and is a direct reflect of the signal complexity
Measured: Day 0 (during 20 to 30 minutes sliding windows during labor)
Support vector machine (SVM) classification
SVM permits to select a small number of relevant features from the different method of analysis previously described and to discriminate fetuses with and without acidosis
Measured: Day 0 (during 20 to 30 minutes sliding windows during labor)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: This study is terminated because of problems wtih the society responsible of the data base.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 3,563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835417
- Sponsor's protocol ID
- D50718
- Acronym
- FETUSES
- Status last verified
- May 2020
- First submitted
- 13 Jul 2016
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES)
- ClinicalTrials.gov ID
- NCT02835417
- Acronym / sponsor ID
- FETUSES / D50718
- Conditions
- Fetal Heart Rate Variability
- Keywords
- fetal heart rate variability, entropy, multifractal analysis, scattering transform, sparse vector machine, acidosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study is terminated because of problems wtih the society responsible of the data base.
- Enrolment
- 3,563 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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.
Background
The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis. FHR variability is traditionally investigated using Fourier transform, however, fetal conditions differ from adults (higher frequency, widely instable signal) modifying spectrum repartition along frequencies, making this approach inappropriate. New mathematic approach, including Multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor based wavelet entropy rate measures, scattering transform, may identify parameters associated with fetal acidosis. Modern classification system, driven by the data, based on these relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the clinician in decision making for the management and termination of labor. Analysing 20 to 30 minutes sliding windows with these different methods in a limited number of cases (foetus born with acidosis) and controls (foetus without acidosis) should lead to identify relevant parameters, which will be submitted to these classification tools. For external validation, a large database, including more than 4500 FHR recording documented with foetal outcomes, will be used to evaluate the performance of the combination of parameters identify and classification system used to discriminate foetuses at risk for short term acidosis or not, in order to give a relevant information to the clinician before acidosis occurs, to make the appropriate decision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All fetuses with STAN surveillance during labor.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Women with recirdin lasting less than 60 minutes, with more than 20 % of missing data, or more than 20 minutes between the end of recording and birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hurst parameter comes from multifractal analysis
Time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.
P-leader comes from multifractal analysis
Time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.
4 secondary outcomes
Scattering transform
Time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Entropy rate
Time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)
adaptative multiscale complexity analysis
Time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Support vector machine (SVM) classification
Time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Results and safety
The study was stopped early (reason given: This study is terminated because of problems wtih the society responsible of the data base.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Heart Rate Variability, run by Hospices Civils de Lyon.
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 0 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: stopped early, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: This study is terminated because of problems wtih the society responsible of the data base.). Results are not available in the source record.
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?
Hurst parameter comes from multifractal analysis (time frame: Day 0 (during 20 to 30 minutes sliding windows during labor)). The study lists 2 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 21 May 2020.