Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement (RCF-ABDO)
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|ClinicalTrials.gov Identifier: NCT03741569|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : March 31, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741569
|Contact: charles Garrabedian, MD||03 20 44 66 26 ext +email@example.com|
|Hôpital Roger Salengro, CHU||Recruiting|
|Principal Investigator: Charles Garabedian, MD,PhD|
|Principal Investigator:||Charles Garrabedian, MD||University Hospital, Lille|