Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 14, 2022

Interventions

  • Device: Transabdominal Fetal Heart Rate
    • 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

Arms, Groups and Cohorts

  • Other: parturients (gestational age ≥37 weeks).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant woman – Age>18 years Exclusion Criteria:

  • Multiple pregnancy – Medical termination of pregnancy

Gender Eligibility: Female

Pregnant woman

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charles Garrabedian, MD, Principal Investigator, University Hospital, Lille

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