Skip to main content
OpenTrials
Completed

NCT Number: NCT05263427

Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstetrical Complications Monitoring Injury of Scalp of Newborn

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant woman in labor
  • Singleton
  • Cephalic presentation

Exclusion criteria

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

Treatment and study plan

Toconaute

Device

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

Primary outcomes

  1. Fetal heart rate with the TOCONAUTE

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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)

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Acronym: MOMA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Dec 8, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.