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Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05263427
Collaborator
Clinical Investigation Centre for Innovative Technology Network (Other), BioSerenity (Industry), National Research Agency, France (Other)
60
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TOCONAUTE
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: TOCONAUTE and gold standard : cardiotocograph

Device: TOCONAUTE
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.
Other Names:
  • foetal heart rate and uterine contractions recording

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fetal heart rate with the TOCONAUTE [1 year]

      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.

    Secondary Outcome Measures

    1. Uterine contractions with the TOCONAUTE according to the different phase of labor. [1 year]

      Measure of the uterine contractions with the TOCONAUTE compared to the measure of the uterine contractions with a cardiotocograph according to the different phase of labor. Both signals of the uterine contractions will be resynchronized and compared sample by sample with a Pearson's correlation test.

    2. Maternal heart rate with the TOCONAUTE [1 year]

      Measure of the maternal heart rate with the TOCONAUTE compared to the measure of the maternal heart rate with a cardiotocograph. Both signals of the maternal heart rate will be resynchronized and compared sample by sample with a Pearson's correlation test.

    3. Fetal heart rate with the TOCONAUTE according to the different phase of labor. [1 year]

      Measure of the fetal heart rate with the TOCONAUTE compared to the measure of the fetal heart rate with a cardiotocograph according to the different phase of labor.

    4. Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation) [1 year]

      Feasibility of the measure of the Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pregnant woman in labor

    • Singleton

    • Cephalic presentation

    Exclusion Criteria:

    • Hospitalisation for a medical termination of pregnancy

    • Death in utero

    • Multiple pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille
    • Clinical Investigation Centre for Innovative Technology Network
    • BioSerenity
    • National Research Agency, France

    Investigators

    • Principal Investigator: Charles Garabedian, MD,PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05263427
    Other Study ID Numbers:
    • 2021_0548
    • 2022-A00107-36
    • ANR-18-CE19-0015-01
    First Posted:
    Mar 2, 2022
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Fetal Heart Rate
    Monitoring
    Uterine contraction
    Electrocardiogram

    Study Results

    No Results Posted as of Mar 2, 2022