Clinical trial NCT02835417: Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES)
Official title: Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fetal Heart Rate Variability
Keywords: fetal heart rate variability
entropy
multifractal analysis
scattering transform
sparse vector machine
acidosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 3563
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All fetuses with STAN surveillance during labor.

Brief 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, 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.


Eligibility criteria: --- Inclusion Criteria:

* women with singleton pregnancy and fetal ECG recording using a scalp electrode, with recording lasting more than 60 minutes, with less than 20 % of missing data and less than 20 minutes between the end of recording and birth.

  * Exclusion Criteria:
* 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.

Primary outcomes:
measure: Hurst parameter comes from multifractal analysis
timeFrame: Day 0 (during 20 to 30 minutes sliding windows during labor)
measure: P-leader comes from multifractal analysis
timeFrame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Secondary outcomes:
measure: Scattering transform
timeFrame: Day 0 (during 20 to 30 minutes sliding windows during labor)
measure: Entropy rate
timeFrame: Day 0 (during 20 to 30 minutes sliding windows during labor)
measure: adaptative multiscale complexity analysis
timeFrame: Day 0 (during 20 to 30 minutes sliding windows during labor)
measure: Support vector machine (SVM) classification
timeFrame: Day 0 (during 20 to 30 minutes sliding windows during labor)
Other outcomes:
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