Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

NCT03741569 | Completed

• 2 other identifiers: 2017_632018-A01194-51
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Obstetric Labor

Keywords

Fetal heart rate; Multiple sensors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The uterine contraction signal

  at 15 minutes

• Measuring the root mean square deviation between the heart rate signals from the device and the Doppler

  at 15 minutes

Study Arms (1)

parturients (gestational age ≥37 weeks).

OTHER

Device: Transabdominal Fetal Heart Rate

Interventions

Transabdominal Fetal Heart Rate DEVICE

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

Also known as: Fetal heart rate recording

parturients (gestational age ≥37 weeks).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman
• Age\>18 years

You may not qualify if:

• Multiple pregnancy
• Medical termination of pregnancy

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Study Officials

• Charles Garrabedian, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: October 17, 2017
• Primary Completion: June 14, 2022
• Study Completion: July 17, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

FR (1)