Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection

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

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can reduce the incidence of surgical site infection after emergency cesarean section.

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Detailed Description

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Surgical site infection (SSI) is one of the most important complications that can develop after a cesarean section. SSI can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. Supplemental oxygen at high doses has been advocated as a protective factor for SSI. The purpose of this study is to determine if the use of oxygen at high doses (80% FIO2)can reduce the incidence of SSI after emergency cesarean section.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oxygen 80% FIO2

Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.

Group Type EXPERIMENTAL

Supplemental oxygen 80% FIO2

Intervention Type DEVICE

Use of oxygen 80% FIO2 during surgery and 2 hours after the procedure. For this purpose an oxygen mask with reservoir will be used (to guarantee the supply of 80% oxygen during and after surgery)

Use of air (no oxygen during surgery)

Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).

Group Type PLACEBO_COMPARATOR

Use of air (no oxygen during surgery)

Intervention Type PROCEDURE

No use of oxygen during surgery or in the 2 hours after the procedure.

Interventions

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Supplemental oxygen 80% FIO2

Use of oxygen 80% FIO2 during surgery and 2 hours after the procedure. For this purpose an oxygen mask with reservoir will be used (to guarantee the supply of 80% oxygen during and after surgery)

Intervention Type DEVICE

Use of air (no oxygen during surgery)

No use of oxygen during surgery or in the 2 hours after the procedure.

Intervention Type PROCEDURE

Other Intervention Names

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High dose oxygen No oxygen

Eligibility Criteria

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Inclusion Criteria

* Gestational age \> 37 weeks
* Emergency cesarean section
* Regional Anesthesia

Exclusion Criteria

* Elective cesarean section
* Fever of unknown origin at admission
* Twin pregnancy
* Chorioamnionitis
* Acute fetal distress that requires general anesthesia
* Immunocompromise
* Maternal Lung/Respiratory Disease

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No