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Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

NCT ID: NCT00670020

Last Updated: 2008-05-01

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

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to determine whether supplemental perioperative oxygen significantly decreases the incidence of post-Cesarean endometritis and wound infection among women who undergo Cesarean section after the onset of labor.

Detailed Description

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Women undergoing cesarean section after rupture of membranes or onset of labor are randomized in a one to one ratio to either normal or supplemental perioperative oxygen during cesarean section and for two hours afterwards.

Conditions

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Wound Infection or Endometritis Post Cesarean Section

Keywords

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Women undergoing Cesarean section after the onset of labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

supplemental perioperative oxygen

Group Type EXPERIMENTAL

supplemental perioperative oxygen

Intervention Type PROCEDURE

increased perioperative oxygen verses non-interventional oxygen

2

Normal

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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supplemental perioperative oxygen

increased perioperative oxygen verses non-interventional oxygen

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes

Exclusion Criteria

* Cesarean delivery prior to the onset of labor or rupture of membranes
* emergent cesarean delivery
* general endotracheal anesthesia
* clinical chorioamnionitis
* HIV infection
* less than 16 years of age
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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Carolyn M Gardella, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington Dept of Ob/Gyn

Other Identifiers

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18821

Identifier Type: -

Identifier Source: org_study_id