NCT02785367|UnknownPhase 4DMC
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Sponsor study identifier
interventional
1,000
0 countries
N/A
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The pH levels of a neonatal at his birth are an important factor in establishing the connection between events that occurred during the actual time of birth, to the risk of a significant morbidity development in the future. Gas values in cord blood are measurable and represent the condition of the fetus close to the time of birth. Their level is one of the essential criteria which are used to define acute hypoxic event during birth. As the oxygen supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing. Therefore, the tissues begin to accumulate large amounts of acid and thereby developing fetal blood acidosis. Many works connected the presence of cord blood acidosis to development of neonatal cerebral palsy. According to the American Association of Obstetrics and Gynecology, cord blood gas sample is necessary when a prenatal event may be related (rightly or not) with negative neonatal outcome. This approach might be necessary when the case is legally controversial and there is a need to prove that umbilical cord gas values were normal at the prenatal period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2016
Actual (reported)May 27, 2016
Actual (reported)June 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
gas values
gas(pH) values will be examined at different times after the birth.
60 minutes
8 cord blood samples will be taken from the umbilical cord in 8 syringes of about 3 ml washed with Heparin.
After delivery, 8 cord blood samples will be taken from the umbilical cord in 8 syringes of about 3 ml, washed with Heparin (Designated syringes exist in the delivery room). 4 syringes will be stored in room temperature. Thermometer will be attached to any sample, and temperature values will be indicated before any measurement. The samples will be measured in a gas measurement device, in 4 time points: at the birth, after 15 minutes, after 30 minutes and after 60 minutes from the birth.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yariv Yogev, professor
Tel Aviv Medical Center
First Submitted
May 25, 2016
First Posted
May 27, 2016
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2019
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 27, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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