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Completed

NCT Number: NCT03741569

Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement

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

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Key information

Conditions

Obstetric Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant woman
  • Age>18 years

Exclusion criteria

  • Multiple pregnancy
  • Medical termination of pregnancy

Treatment and study plan

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

Other names: Fetal heart rate recording

Primary outcomes

  1. The fetal heart rate signal

    Time frame: 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 outcomes

  1. The uterine contraction signal

    Time frame: 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.

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

    Time frame: at 15 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: RCF-ABDO

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2018
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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