Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

Study Overview
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Brief Summary
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The CIC-IT 1403 laboratory of the University Hospital of Lille has developed a technological solution for acquiring and synchronizing abdominal ECG, acoustic and Doppler signals. The purpose of this clinical trial is to build a database of signals issued from this device to develop signal processing algorithms to allow optimization of the fetal heart rate calculation. This study will be carried out in the maternity ward of the Jeanne de Flandre Hospital in the maternal-fetal pathology department Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions. For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes. This procedure will not affect the usual care of the patient

Official Title
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Development of a Real-time Signal Processing Algorithm, for Beat-beat Measurement of Fetal Heart Rate and Uterine Contractions by Coupling Non-invasive ABDOminal Sensors

Conditions
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Obstetric Labor

Intervention / Treatment
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* Device: Transabdominal Fetal Heart Rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman Age>18 years Exclusion Criteria: Multiple pregnancy Medical termination of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: parturients (gestational age ≥37 weeks).<br> | Device: Transabdominal Fetal Heart Rate<br>* Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions. For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes<br>* Other names: Fetal heart rate recording;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fetal heart rate signal | The fetal heart rate signal extraction algorithm will be based on the various signal processing tools developed by the INSERM CIC-IT 1403 laboratory | at 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The uterine contraction signal | The uterine contraction signal extraction algorithm will be based on the different signal processing tools developed by the INSERM CIC-IT 1403 laboratory. | at 15 minutes | 
| Measuring the root mean square deviation between the heart rate signals from the device and the Doppler |  | at 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal heart rate, Multiple sensors