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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014