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Clinical Trials/NCT02804555
NCT02804555
Completed
Not Applicable

Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section

Szeged University1 site in 1 country107 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstetrical Complication of Anesthesia
Sponsor
Szeged University
Enrollment
107
Locations
1
Primary Endpoint
Hyperoxia Newborns
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.

Detailed Description

Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
November 30, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Szeged University
Responsible Party
Principal Investigator
Principal Investigator

Domonkos Trásy

clinician

Szeged University

Eligibility Criteria

Inclusion Criteria

  • Elective cesarean section.
  • Signed informed consent form.

Exclusion Criteria

  • Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.

Outcomes

Primary Outcomes

Hyperoxia Newborns

Time Frame: through study completion up to two years

We measured umbilical vein blood gas parameters.

Secondary Outcomes

  • Maternal hyperoxia(through study completion up to two years)
  • Alterations in newborns' enzyme functions due to maternal hyperoxia(through study completion up to two years)

Study Sites (1)

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