NCT02804555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

April 27, 2017

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

June 6, 2016

Last Update Submit

April 26, 2017

Conditions

Obstetrical Complication of Anesthesia

Keywords

reactive oxygen specieselective cesarean sectionoxygen therapynewborn

Outcome Measures

Primary Outcomes (1)

  • Hyperoxia Newborns

    We measured umbilical vein blood gas parameters.

    through study completion up to two years

Secondary Outcomes (2)

  • Maternal hyperoxia

    through study completion up to two years

  • Alterations in newborns' enzyme functions due to maternal hyperoxia

    through study completion up to two years

Study Arms (2)

Oxygen support

ACTIVE COMPARATOR

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

Other: Oxygen

Room air

NO INTERVENTION

Oxygen support has not given to the mothers.

Interventions

OxygenOTHER

Oxygen administration

Oxygen support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cesarean section.
  • Signed informed consent form.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6725, Hungary

Location

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Zsolt Molnar, MD

    Szeged University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinician

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 17, 2016

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

November 30, 2016

Last Updated

April 27, 2017

Record last verified: 2016-11

Locations

HU(1)