Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

Obstetrical Complications Clinical Trial

— MOMA  

Official title:

Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263427
• Other study ID #: 2021_0548
• Secondary ID: 2022-A00107-36AN
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Charles Garabedian, MD,PhD
• Phone: 0320445962
• Email: charles.garabedian[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant woman in labor

• Singleton

• Cephalic presentation

Exclusion Criteria:

• Hospitalisation for a medical termination of pregnancy

• Death in utero

• Multiple pregnancy

Related Conditions & MeSH terms

• Obstetrical Complications

Intervention

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.

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (4)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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