Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

Not Applicable

• Conditions: Monitoring Injury of Scalp of Newborn; Obstetrical Complications
• Interventions: Device: TOCONAUTE

• Registration Number: NCT05263427
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2022-08-31
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Pregnant woman in labor
• Singleton
• Cephalic presentation

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOCONAUTE and gold standard : cardiotocograph	TOCONAUTE	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)
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.
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.

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France