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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02804555
Enrollment
107
Registered
2016-06-17
Start date
2013-06-30
Completion date
2016-11-30
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetrical Complication of Anesthesia

Keywords

reactive oxygen species, elective cesarean section, oxygen therapy, newborn

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.

Interventions

OTHEROxygen

Oxygen administration

Sponsors

Szeged University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hyperoxia Newbornsthrough study completion up to two yearsWe measured umbilical vein blood gas parameters.

Secondary

MeasureTime frameDescription
Maternal hyperoxiathrough study completion up to two yearsWe measured arterial blood gas parameters of the mother from radial artery.
Alterations in newborns' enzyme functions due to maternal hyperoxiathrough study completion up to two yearsWe measured umbilical vein reactive oxygen species (ROS) of the newborn.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026