NCT05263427

Brief Summary

During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions. The goal here is to assess the performance of the device in real situation during labour. This study will be carried out in the maternity labor ward in CHU Lille, France. The TOCONAUTE will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph. For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

February 21, 2022

Last Update Submit

December 2, 2025

Conditions

Obstetrical ComplicationsMonitoring Injury of Scalp of Newborn

Keywords

Fetal Heart RateMonitoringUterine contractionElectrocardiogram

Outcome Measures

Primary Outcomes (1)

  • Fetal heart rate with the TOCONAUTE

    The fetal heart rate from the our device will be averaged on 3 beats and resampled at 4Hz to be comparable to the fetal heart rate from the cardiotocograph. Both of the signals will be resynchronized and compared sample by sample with a Pearson's correlation test. Measure of the fetal heart rate with the TOCONAUTE compared to the measure of the fetal heart rate with a cardiotocograph.

    1 year

Secondary Outcomes (4)

  • Uterine contractions with the TOCONAUTE according to the different phase of labor.

    1 year

  • Maternal heart rate with the TOCONAUTE

    1 year

  • Fetal heart rate with the TOCONAUTE according to the different phase of labor.

    1 year

  • Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)

    1 year

Study Arms (1)

TOCONAUTE and gold standard : cardiotocograph

EXPERIMENTAL
Device: TOCONAUTE

Interventions

TOCONAUTEDEVICE

This study will be carried out during delivery. The will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph. For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.

Also known as: foetal heart rate and uterine contractions recording
TOCONAUTE and gold standard : cardiotocograph

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPRegnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant woman in labor
  • Singleton
  • Cephalic presentation

You may not qualify if:

  • Hospitalisation for a medical termination of pregnancy
  • Death in utero
  • Multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

Related Publications (1)

  • Wojtanowski A, Garabedian C, Charlier P, Prot P, Ghesquiere L, De Jonckheere J. Intrapartum monitoring of the fetal heart rate using transabdominal electrocardiography: A reliability and accuracy study. J Gynecol Obstet Hum Reprod. 2025 May;54(5):102942. doi: 10.1016/j.jogoh.2025.102942. Epub 2025 Mar 16.

    PMID: 40101837RESULT

Study Officials

  • Charles Garabedian, MD,PhD

    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

February 21, 2022

First Posted

March 2, 2022

Study Start

August 31, 2022

Primary Completion

November 3, 2023

Study Completion

November 3, 2023

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations

FR(1)