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CompletedNCT02804555Updated Apr 27, 2017

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

An interventional study of Oxygen in Obstetrical Complication of Anesthesia, sponsored by Szeged University. Completed at 1 site in Hungary. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by Szeged University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Obstetrical Complication of Anesthesia

Keywords

  • reactive oxygen species
  • elective cesarean section
  • oxygen therapy
  • newborn
03

In context

Lead sponsor

Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elective cesarean section.
  • Signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
107 participants (actual)

Study arms

  • Active comparator
    Oxygen support

    5 liter / minute oxygen has given to the mothers on face mask.

    Other: Oxygen

  • No intervention
    Room air

    Oxygen support has not given to the mothers.

Interventions

  • OtherOxygen

    Oxygen administration

06

What researchers measure

Primary outcomes

  1. Hyperoxia Newborns

    We measured umbilical vein blood gas parameters.

    Time frame: through study completion up to two years

Secondary outcomes

  1. Maternal hyperoxia

    We measured arterial blood gas parameters of the mother from radial artery.

    Time frame: through study completion up to two years

  2. Alterations in newborns' enzyme functions due to maternal hyperoxia

    We measured umbilical vein reactive oxygen species (ROS) of the newborn.

    Time frame: through study completion up to two years

07

Study locations

1 site
  • Department of Anaesthesiology and Intensive Therapy
    Szeged, Csongrád 6725, Hungary
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02804555
Lead sponsor
Szeged University
Responsible party
Domonkos Trásy (clinician, Szeged University) — Principal investigator
First posted
Jun 17, 2016
Start date
Jun 2013
Primary completion
Jun 2016
Completion
Nov 30, 2016
Last update
Apr 27, 2017

Study contacts

Zsolt Molnar, MD
principal investigator · Szeged University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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