Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03741569

Acronym

RCF-ABDO

Enrollment

Registered

2018-11-15

Start date

2017-10-17

Completion date

2022-07-17

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor

Keywords

Fetal heart rate, Multiple sensors

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

Interventions

DEVICETransabdominal 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pregnant woman * Age\>18 years

Exclusion criteria

* Multiple pregnancy * Medical termination of pregnancy

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Measuring the root mean square deviation between the heart rate signals from the device and the Doppler	at 15 minutes	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026