Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03741569
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Obstetric Labor Device: Transabdominal Fetal Heart Rate Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
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 Name: Fetal heart rate recording




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   parturients (gestational age ≥37 weeks).
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant woman
  • Gestational age>36 weeks
  • Age>18 years

Exclusion Criteria:

  • Multiple pregnancy
  • Medical termination of pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741569


Contacts
Layout table for location contacts
Contact: charles Garrabedian, MD 03 20 44 66 26 ext +33 charles.garabedian@chru-lille.fr

Locations
Layout table for location information
France
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: Charles Garabedian, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Charles Garrabedian, MD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03741569     History of Changes
Other Study ID Numbers: 2017_63
2018-A01194-51 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Fetal heart rate
Multiple sensors