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Sponsors and Collaborators: |
Washington University School of Medicine Barnes-Jewish Hospital Foundation Department of Obstetrics and Gynecology Division of Clinical Research |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00603603 |
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 inhaled room air through a face mask 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.
Condition | Intervention |
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Cesarean Section Surgical Wound Infection Endometritis |
Other: 80% inhaled oxygen via non-rebreather mask Other: placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity |
Estimated Enrollment: | 556 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Other: 80% inhaled oxygen via non-rebreather mask
Patients randomized to treatment group will receive 80% inhaled oxygen via a non-rebreather face mask during their cesarean section and for 2 hours afterwards.
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2: Placebo Comparator |
Other: placebo
Patients will receive inhaled room air (21% inhaled oxygen) at a flow of 10L/minute via non-rebreather mask.
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Ages Eligible for Study: | 12 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christina Scifres, M.D. | (314)362-7300 | scifresc@wudosis.wustl.edu |
United States, Missouri | |
Barnes Jewish Hospital/Washington University School. of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | David Stamilio, M.D. | Washington University Department of Obstetrics and Gynecology |
Responsible Party: | Washington University Department of Obstetrics and Gynecology ( David Stamilio, M.D., M.S.C.E. ) |
Study ID Numbers: | 07-0598 |
Study First Received: | January 17, 2008 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00603603 |
Health Authority: | United States: Institutional Review Board |
C-section Surg Wound Infect |
Genital Diseases, Female Endometritis Postoperative Complications Wounds and Injuries Disorders of Environmental Origin |
Uterine Diseases Pelvic Inflammatory Disease Surgical Wound Infection Wound Infection |
Pathologic Processes Infection Adnexal Diseases |