Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

Study Overview
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Brief Summary
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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.

Official Title
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Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

Conditions
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Obstetrical Complications, Monitoring Injury of Scalp of Newborn

Intervention / Treatment
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* Device: TOCONAUTE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman in labor Singleton Cephalic presentation Exclusion Criteria: Hospitalisation for a medical termination of pregnancy Death in utero Multiple pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOCONAUTE and gold standard : cardiotocograph<br> | Device: TOCONAUTE<br>* 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.<br>* Other names: foetal heart rate and uterine contractions recording;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitoring, Fetal Heart Rate, Uterine contraction, Electrocardiogram