Effect of Maternal and Neonatal Oxygenation

NCT ID: NCT01530971

Last Updated: 2013-07-02

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns.

Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.

Detailed Description

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Supplemental oxygen has been routinely given to parturients because doctors were concerned about desaturation. However, the evidences for giving oxygen was not strong, and the condition nowadays can be detected immediately with pulse oximeter which is a standard monitoring.

After this study finished, we will set a safety guideline for supplemental oxygen for healthy parturients undergoing elective cesarean section.

Conditions

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Peer Review, Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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room air

no supplemental oxygen in intraoperative period

Group Type NO_INTERVENTION

No interventions assigned to this group

Oxygen

Supplemental 3LPM oxygen via canula

Group Type EXPERIMENTAL

Supplemental 3LPM oxygen via canula

Intervention Type DRUG

Parturients will receive supplemental oxygen (3LPM) via nasal canula

Interventions

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Supplemental 3LPM oxygen via canula

Parturients will receive supplemental oxygen (3LPM) via nasal canula

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged \> 18 years old.
* Term pregnancy (gestational age 37 -42 weeks).
* Singleton
* Elective cesarean section.

Exclusion Criteria

* History of infertility
* Diabetes
* Hypertension or preeclampsia
* Heart disease
* Morbid obesity
* Premature rupture of membrane
* Placenta previa
* Preoperative oxygen saturation \< 95%
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arunotai Siriussawakul, MD.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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10AS00008/044/10

Identifier Type: -

Identifier Source: org_study_id

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