Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection
April 30, 2008 updated by: University of Washington
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
supplemental perioperative oxygen
|
increased perioperative oxygen verses non-interventional oxygen
|
|
No Intervention: 2
Normal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
surgical site infection
Time Frame: within two weeks of cesarean section
|
within two weeks of cesarean section
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carolyn M Gardella, MD, MPH, University of Washington Dept of Ob/Gyn
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
April 29, 2008
First Submitted That Met QC Criteria
April 30, 2008
First Posted (Estimate)
May 1, 2008
Study Record Updates
Last Update Posted (Estimate)
May 1, 2008
Last Update Submitted That Met QC Criteria
April 30, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18821
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.