Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA (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.

Study Overview

• Status: Completed
• Conditions: Obstetrical Complications; Monitoring Injury of Scalp of Newborn
• Intervention / Treatment: Device: TOCONAUTE

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant woman in labor
• Singleton
• Cephalic presentation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine contractions with the TOCONAUTE according to the different phase of labor.	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.	1 year
Maternal heart rate with the TOCONAUTE	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.	1 year
Fetal heart rate with the TOCONAUTE according to the different phase of labor.	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.	1 year
Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)	Feasibility of the measure of the Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: National Research Agency, France; Clinical Investigation Centre for Innovative Technology Network; BioSerenity
• Investigators: Principal Investigator: Charles Garabedian, MD,PhD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Monitoring; Electrocardiogram; Fetal Heart Rate; Uterine contraction
• Other Study ID Numbers: 2021_0548; 2022-A00107-36 (Other Identifier: ID-RCB number, ANSM); ANR-18-CE19-0015-01 (Other Identifier: AAP number, ANR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No