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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670020
First Posted: May 1, 2008
Last Update Posted: May 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Washington
  Purpose
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.

Condition Intervention
Wound Infection or Endometritis Post Cesarean Section Procedure: supplemental perioperative oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • surgical site infection [ Time Frame: within two weeks of cesarean section ]

Enrollment: 143
Study Start Date: January 2001
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
supplemental perioperative oxygen
Procedure: supplemental perioperative oxygen
increased perioperative oxygen verses non-interventional oxygen
No Intervention: 2
Normal

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670020


Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Carolyn M Gardella, MD, MPH University of Washington Dept of Ob/Gyn
  More Information

Responsible Party: Carolyn Gardella, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00670020     History of Changes
Other Study ID Numbers: 18821
First Submitted: April 29, 2008
First Posted: May 1, 2008
Last Update Posted: May 1, 2008
Last Verified: April 2008

Keywords provided by University of Washington:
Women undergoing Cesarean section after the onset of labor

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases