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

University Hospital, Lille

Status: Completed

Conditions: Obstetric Labor

Treatments: Device: Transabdominal Fetal Heart Rate

Study type: Interventional

Funder types: Other

Identifiers

NCT03741569

2018-A01194-51 (Other Identifier)

2017_63

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant woman
• Age>18 years

Exclusion criteria

• Multiple pregnancy
• Medical termination of pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

parturients (gestational age ≥37 weeks).

Other group

Treatment:

Device: Transabdominal Fetal Heart Rate