Sponsor study identifier
interventional
100
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 11, 2014
Actual (reported)January 6, 2015
Actual (reported)September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Reliability
12 months
Reliability
12 months
Reliability
12 months
Accuracy
12 months
Accuracy
12 months
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rabin Medical Center
Petah Tikva, Israel, Israel
Yariv Yogev, professor
Director, division of obstetrics and delivery ward Rabin medical center
First Submitted
December 11, 2014
First Posted
January 6, 2015
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Contact the study team to confirm eligibility.
September 2015
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 9, 2015
Record last verified: 2015-09
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Source: ClinicalTrials.gov.
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