Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

University Hospital, Lille

Status: Completed

Conditions: Monitoring Injury of Scalp of Newborn; Obstetrical Complications

Treatments: Device: TOCONAUTE

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT05263427

ANR-18-CE19-0015-01 (Other Identifier)

2022-A00107-36 (Other Identifier)

2021_0548

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant woman in labor
• Singleton
• Cephalic presentation

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

TOCONAUTE and gold standard : cardiotocograph

Experimental group

Treatment:

Device: TOCONAUTE