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| Name | Class |
|---|---|
| OB-Tools Ltd. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scalp electrode, fetal doppler and EUM | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalp electrode, fetal doppler and EUM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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). | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability | Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler) | 12 months |
| Reliability | Mean Positive Predictive Value (PPV) for individual tracing identification (between EUM, scalp electrode and fetal doppler) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yariv Yogev, professor | Contact | 972-3-9377494 | yarivy@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Yariv Yogev, professor | Director, division of obstetrics and delivery ward Rabin medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel | Israel |
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| 12 months |
| Reliability | The mean False Positive Rate (FPR) for individual tracing identification (between EUM, scalp electrode and fetal Doppler) | 12 months |
| Accuracy | The difference in fetal heart rate baseline and variability (between EUM, scalp electrode and fetal doppler) | 12 months |
| Accuracy | The difference in periodic changes (between EUM, scalp electrode and fetal Doppler). | 12 months |
| Adverse events | Number and percentage of adverse events during the study period | 12 months |