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

Primary Purpose

Wound Infection or Endometritis Post Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
supplemental perioperative oxygen
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection or Endometritis Post Cesarean Section focused on measuring Women undergoing Cesarean section after the onset of labor

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    supplemental perioperative oxygen

    Normal

    Outcomes

    Primary Outcome Measures

    surgical site infection

    Secondary Outcome Measures

    Full Information

    First Posted
    April 29, 2008
    Last Updated
    April 30, 2008
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00670020
    Brief Title
    Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection
    Official Title
    Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Washington

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Infection or Endometritis Post Cesarean Section
    Keywords
    Women undergoing Cesarean section after the onset of labor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    143 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    supplemental perioperative oxygen
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    Normal
    Intervention Type
    Procedure
    Intervention Name(s)
    supplemental perioperative oxygen
    Intervention Description
    increased perioperative oxygen verses non-interventional oxygen
    Primary Outcome Measure Information:
    Title
    surgical site infection
    Time Frame
    within two weeks of cesarean section

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carolyn M Gardella, MD, MPH
    Organizational Affiliation
    University of Washington Dept of Ob/Gyn
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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