Monitoring Injury of Scalp of Newborn, Obstetrical Complications
Conditions
Keywords
Fetal Heart Rate, Monitoring, Uterine contraction, Electrocardiogram
Brief 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.
Interventions
DEVICETOCONAUTE
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.
Sponsors
Clinical Investigation Centre for Innovative Technology Network
BioSerenity
National Research Agency, France
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant woman in labor * Singleton * Cephalic presentation
Exclusion criteria
* Hospitalisation for a medical termination of pregnancy * Death in utero * Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal heart rate with the TOCONAUTE | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine contractions with the TOCONAUTE according to the different phase of labor. | 1 year | 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. |
| Maternal heart rate with the TOCONAUTE | 1 year | 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. |
| Fetal heart rate with the TOCONAUTE according to the different phase of labor. | 1 year | 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. |
| Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation) | 1 year | Feasibility of the measure of the Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation) |
Countries
France
Outcome results
None listed