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

January 17, 2008
May 26, 2009
February 2008
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00603603 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity
Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cesarean Section
  • Surgical Wound Infection
  • Endometritis
  • 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.
  • 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.
  • Active Comparator: 1
    10 liters of oxygen via non re-breather mask during cesarean section and up to two hours post-operatively
    Intervention: Other: 80% inhaled oxygen via non-rebreather mask
  • Active Comparator: 2
    2 liters of oxygen via nasal cannula (standard of care) during cesarean section only
    Intervention: Other: 30% inhaled oxygen via nasal cannula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
556
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Female
12 Years to 50 Years
Yes
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
United States
 
NCT00603603
07-0598
No
David Stamilio, M.D., M.S.C.E., Washington University Department of Obstetrics and Gynecology
Washington University School of Medicine
  • Barnes-Jewish Hospital
  • Department of Obstetrics and Gynecology Division of Clinical Research
Principal Investigator: David Stamilio, M.D. Washington University Department of Obstetrics and Gynecology
Washington University School of Medicine
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP