Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement (RCF-ABDO)

December 15, 2022 updated by: University Hospital, Lille

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Roger Salengro, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant woman
  • Age>18 years

Exclusion Criteria:

  • Multiple pregnancy
  • Medical termination of pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: parturients (gestational age ≥37 weeks).
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

Other Names:
  • Fetal heart rate recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 15 minutes
Measuring the root mean square deviation between the heart rate signals from the device and the Doppler
Time Frame: at 15 minutes
at 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Charles Garrabedian, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2017

Primary Completion (Actual)

June 14, 2022

Study Completion (Actual)

July 17, 2022

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017_63
  • 2018-A01194-51 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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