Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section

April 26, 2017 updated by: Domonkos Trásy, Szeged University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Csongrád
      • Szeged, Csongrád, Hungary, 6725
        • Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxygen support
5 liter / minute oxygen has given to the mothers on face mask.
Other: Oxygen
Oxygen administration
No Intervention: Room air
Oxygen support has not given to the mothers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperoxia Newborns
Time Frame: through study completion up to two years
We measured umbilical vein blood gas parameters.
through study completion up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal hyperoxia
Time Frame: through study completion up to two years
We measured arterial blood gas parameters of the mother from radial artery.
through study completion up to two years
Alterations in newborns' enzyme functions due to maternal hyperoxia
Time Frame: through study completion up to two years
We measured umbilical vein reactive oxygen species (ROS) of the newborn.
through study completion up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Investigators

  • Principal Investigator: Zsolt Molnar, MD, Szeged University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Maternal hyperoxia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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