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

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00670020
First received: April 29, 2008
Last updated: April 30, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • surgical site infection [ Time Frame: within two weeks of cesarean section ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670020

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

No publications provided

Responsible Party: Carolyn Gardella, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00670020     History of Changes
Other Study ID Numbers: 18821
Study First Received: April 29, 2008
Last Updated: April 30, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013