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Completed

NCT Number: NCT02804555

Effects of Intraoperative Oxygen Therapy on Oxygenation 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.

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Key information

Conditions

Obstetrical Complication of Anesthesia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6725, Hungary

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen

Other

Oxygen administration

Primary outcomes

  1. Hyperoxia Newborns

    Time frame: through study completion up to two years

    We measured umbilical vein blood gas parameters.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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