Changes of Gas Values in Cord Blood Versus Time and Temperature

NCT ID: NCT02785367

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Abnormal; Birth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cord blood samples

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

Group Type EXPERIMENTAL

Cord blood samples

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yariv Yogev, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

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Yariv Yogev, professor

Role: CONTACT

052-7360616

Other Identifiers

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0042-46-tlv

Identifier Type: -

Identifier Source: org_study_id

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