NCT05263427

Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstetrical Complications
• Monitoring Injury of Scalp of Newborn

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-11-03
• Completion: 2023-11-03
• First posted: 2022-03-02
• Last updated: 2025-12-08

Locations

1 site across 1 country: France