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

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ClinicalTrials.gov Identifier: NCT02804555
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Domonkos Trásy, Szeged University

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.

Condition or disease Intervention/treatment Phase
Obstetrical Complication of Anesthesia Other: Oxygen Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section
Study Start Date : June 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Hyperoxia Newborns [ Time Frame: through study completion up to two years ]
    We measured umbilical vein blood gas parameters.


Secondary Outcome Measures :
  1. Maternal hyperoxia [ Time Frame: through study completion up to two years ]
    We measured arterial blood gas parameters of the mother from radial artery.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804555


Locations
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Hungary
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád, Hungary, 6725
Sponsors and Collaborators
Szeged University
Investigators
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Principal Investigator: Zsolt Molnar, MD Szeged University
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Responsible Party: Domonkos Trásy, clinician, Szeged University
ClinicalTrials.gov Identifier: NCT02804555    
Other Study ID Numbers: Maternal hyperoxia
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Domonkos Trásy, Szeged University:
reactive oxygen species
elective cesarean section
oxygen therapy
newborn