Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
David Stamilio, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00603603
First received: January 17, 2008
Last updated: June 20, 2016
Last verified: June 2016
  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
Infection; 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:


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

Primary Outcome Measures:
  • Composite of Wound Infection and 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 ]

Enrollment: 606
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80% inhaled oxygen-non-rebreather
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: 30% inhaled oxygen-nasal cannula
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603603

Locations
United States, Missouri
Barnes Jewish Hospital/Washington University School. of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
Principal Investigator: David Stamilio, MD Washington University Department of Obstetrics and Gynecology
  More Information

Responsible Party: David Stamilio, Associate Professor, OB/GYN, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00603603     History of Changes
Other Study ID Numbers: 07-0598 
Study First Received: January 17, 2008
Last Updated: June 20, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on September 30, 2016