Changes of Gas Values in Cord Blood Versus Time and Temperature

Abnormal; Birth Clinical Trial

Official title:

Changes of Gas Values in Cord Blood Versus Time and Temperature

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02785367
• Other study ID #: 0042-46-tlv
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 25, 2016
• Last updated: May 25, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: May 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yariv Yogev, professor
• Phone: 052-7360616
• Email: yarivy[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abnormal; Birth

Intervention

Procedure:
• Cord 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gas values	gas(pH) values will be examined at different times after the birth.	60 minutes	No