An interventional study of TOCONAUTE in Obstetrical Complications and Monitoring Injury of Scalp of Newborn, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic
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.
University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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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.
Also known as: foetal heart rate and uterine contractions recording
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 1 year
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille