Clinical trial NCT02785367: Changes of Gas Values in Cord Blood Versus Time and Temperature
Official title: Changes of Gas Values in Cord Blood Versus Time and Temperature
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abnormal; Birth
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-05-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The PH levels of a neonatal in 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 pre-natal period.

Aim of study Our aim is to find the effect of the cord blood sample storage way, and the effect of the sample taking time from the delivery.

Eligibility criteria: Inclusion Criteria:

Gestational age 37 weeks and above. Vaginal or cesarean births.

Exclusion Criteria:

Women who had medical indication to cord blood sample taking for gas measurement (Apgar\<7 in the 5th minute, premature labor (under 37 weeks), multiple pregnancy, vacuum birth, urgent cesarean

Primary outcomes:
measure: gas values
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References: