Changes of Gas Values in Cord Blood Versus Time and Temperature

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.

Study Overview

• Status: Unknown
• Conditions: Abnormal; Birth
• Intervention / Treatment: Procedure: Cord blood samples

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cord blood samples; 8 cord blood samples will be taken from the umbilical cord in 8 syringes of about 3 ml washed with Heparin.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gas values	gas(pH) values will be examined at different times after the birth.	60 minutes

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 0042-46-tlv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO