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Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity

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City:   St. Louis
State:   Missouri
Zip Code:   63110
Conditions:   Cesarean Section - Surgical Wound Infection - Endometritis
Purpose:   Previous studies have demonstrated that patients who undergo surgery while they under general anesthesia have fewer wound infections if they receive higher concentrations of oxygen but this has never been studied in women who are undergoing cesarean section. We plan to randomize women who are undergoing cesarean to receive either standard of care oxygen flow through a nasal cannula during their cesarean section only or a higher concentration of oxygen than they would typically receive through a face mask. Women will receive this therapy during their cesarean and for 2 hours afterwards. We will follow them after their surgery for evidence of infection either in their wound or their uterus.
Study Summary:  
Criteria:   Inclusion Criteria: - Pregnant patients undergoing a scheduled or unscheduled cesarean section with regional anesthesia Exclusion Criteria: - Urgent fetal or maternal indications for cesarean section precluding informed consent - Evidence of extrauterine infection - HIV infection - Chronic steroid or other immunosuppressant use - Patients undergoing general anesthesia
NCT ID:   NCT00603603
Primary Contact:   Principal Investigator
David Stamilio, M.D.
Washington University Department of Obstetrics and Gynecology

David Stamilio, M.D., M.S.C.E.
Phone: (314) 747-6788
Email: stamiliod@wudosis.wustl.edu
Backup Contact:   Email: fogerteyp@wudosis.wustl.edu
Patricia Fogertey, R.N., M.S.N.
Phone: (314) 362-5362
Location Contact:   St. Louis, Missouri 63110
United States

Patty Fogertey, RN
Email: fogerteyp@wustl.edu

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   May 20, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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