Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

Obstetric Labor Clinical Trial

— RCF-ABDO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741569
• Other study ID #: 2017_63
• Secondary ID: 2018-A01194-51
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: July 17, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 17, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman

• Age>18 years

Exclusion Criteria:

• Multiple pregnancy

• Medical termination of pregnancy

Related Conditions & MeSH terms

• Obstetric Labor

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Measuring the root mean square deviation between the heart rate signals from the device and the Doppler		at 15 minutes