Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES) (FETUSES)

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 Overview

• Status: Terminated
• Conditions: Fetal Heart Rate Variability

• Study Type: Observational
• Enrollment (Actual): 3563

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All fetuses with STAN surveillance during labor.

Description

--- 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hurst parameter comes from multifractal analysis	Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.	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.	Day 0 (during 20 to 30 minutes sliding windows during labor)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Day 0 (during 20 to 30 minutes sliding windows during labor)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: acidosis; fetal heart rate variability; entropy; multifractal analysis; scattering transform; sparse vector machine
• Other Study ID Numbers: D50718