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Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity (Peri-Op)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Barnes-Jewish Hospital
Department of Obstetrics and Gynecology Division of Clinical Research
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00603603
First received: January 17, 2008
Last updated: May 26, 2009
Last verified: May 2009
History of Changes
  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.


Condition Intervention
Cesarean Section
Surgical Wound Infection
Endometritis
 Other: 80% inhaled oxygen via non-rebreather mask
Other: 30% inhaled oxygen via nasal cannula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Wound Infection [ Time Frame: 4 weeks post-cesarean ] [ Designated as safety issue: No ]
  • Endometritis [ Time Frame: 4 weeks post-cesarean ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal temperature greater than 38 degrees after the first 24 hours post-op [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Antibiotic usage greater than 24 hours post-op [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Wound opening greater than one centimeter for any cause [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Maternal hospital readmission [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 556
Study Start Date: February 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
10 liters of oxygen via non re-breather mask during cesarean section and up to two hours post-operatively
 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.
Active Comparator: 2
2 liters of oxygen via nasal cannula (standard of care) during cesarean section only
 Other: 30% inhaled oxygen via nasal cannula
Patients randomized to treatment group will receive 30% inhaled oxygen via a nasal cannula (standard of care)during their cesarean section.

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603603

Contacts
Contact: David Stamilio, M.D., M.S.C.E. (314) 747-6788 stamiliod@wudosis.wustl.edu
Contact: Patricia Fogertey, R.N., M.S.N. (314) 362-5362 fogerteyp@wudosis.wustl.edu

Locations
United States, Missouri
Barnes Jewish Hospital/Washington University School. of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Patty Fogertey, RN         fogerteyp@wustl.edu    
Principal Investigator: David Stamilio, M.D., M.S.C.E.            
Sub-Investigator: Christina Scifres, M.D.            
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Department of Obstetrics and Gynecology Division of Clinical Research
Investigators
Principal Investigator: David Stamilio, M.D. Washington University Department of Obstetrics and Gynecology
  More Information

No publications provided

Responsible Party: David Stamilio, M.D., M.S.C.E., Washington University Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00603603     History of Changes
Other Study ID Numbers: 07-0598
Study First Received: January 17, 2008
Last Updated: May 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
C-section
Surg Wound Infect

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

ClinicalTrials.gov processed this record on May 16, 2013