Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.
Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery. study design: 1. signing an informed consent at vas\<3 2. admittance to delivery room. 3. Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation and phases. 4. Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM) simultaneously. 5. Recording fetal heart rate until delivery. 6. Disconnecting the patient from all devices if required according to clinical need.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
100
the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler.
Rabin Medical Center
Petah Tikva, Israel, Israel
RECRUITINGThe difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
Time frame: 12 month
Reliability
Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Time frame: 12 months
Reliability
Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler)
Time frame: 12 months
Reliability
The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler)
Time frame: 12 months
Accuracy
The difference in fetal heart rate baseline and variability (between EUM, scalp electrode and fetal doppler)
Time frame: 12 months
Accuracy
The difference in periodic changes (between EUM, scalp electrode and fetal Doppler).
Time frame: 12 months
Adverse events
Number and percentage of adverse events during the study period
Time frame: 12 months
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