Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

Not Applicable

Completed

• Conditions: Obstetric Labor
• Interventions: Device: Transabdominal Fetal Heart Rate

• Registration Number: NCT03741569
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-17
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Primary Completion: 2022-06-14
• Study Completion: 2022-07-17
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Pregnant woman
• Age>18 years

Exclusion Criteria

• Multiple pregnancy
• Medical termination of pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
parturients (gestational age ≥37 weeks).	Transabdominal Fetal Heart Rate	-

Primary Outcome Measures

Name	Time	Method
The fetal heart rate signal	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

Name	Time	Method
Measuring the root mean square deviation between the heart rate signals from the device and the Doppler	at 15 minutes
The uterine contraction signal	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.

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France