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Changes of Gas Values in Cord Blood Versus Time and Temperature

Changes of Gas Values in Cord Blood Versus Time and Temperature

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02785367
Enrollment
1000
Registered
2016-05-27
Start date
2016-06-30
Completion date
2019-06-30
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal; Birth

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.

Interventions

PROCEDURECord blood samples

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.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
gas values60 minutesgas(pH) values will be examined at different times after the birth.

Contacts

Primary ContactYariv Yogev, professor
yarivy@tlvmc.gov.il052-7360616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026