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

Obstetrical Complication of Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804555
• Other study ID #: Maternal hyperoxia
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: April 26, 2017
• Start date: June 2013
• Est. completion date: November 30, 2016

Study information

• Verified date: November 2016
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 30, 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Obstetrical Complication of Anesthesia

Intervention

Other:
• Oxygen
Oxygen administration

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperoxia Newborns	We measured umbilical vein blood gas parameters.	through study completion up to two years
Secondary	Maternal hyperoxia	We measured arterial blood gas parameters of the mother from radial artery.	through study completion up to two years
Secondary	Alterations in newborns' enzyme functions due to maternal hyperoxia	We measured umbilical vein reactive oxygen species (ROS) of the newborn.	through study completion up to two years