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

NCT ID: NCT02804555

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetrical Complication of Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxygen support

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

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type OTHER

Oxygen administration

Room air

Oxygen support has not given to the mothers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxygen

Oxygen administration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Szeged University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Domonkos Trásy

clinician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zsolt Molnar, MD

Role: PRINCIPAL_INVESTIGATOR

Szeged University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, Hungary

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hungary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Maternal hyperoxia

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Milking the Umbilical Cord at Term Cesarean Birth
NCT01630993 COMPLETED EARLY_PHASE1