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

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

This study is not yet open for participant recruitment.

Verified by Washington University School of Medicine, January 2008

Sponsors and Collaborators:	Washington University School of Medicine Barnes-Jewish Hospital Foundation Department of Obstetrics and Gynecology Division of Clinical Research
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00603603

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 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
Cesarean Section Surgical Wound Infection Endometritis	Other: 80% inhaled oxygen via non-rebreather mask Other: placebo

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

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

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:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
2: Placebo Comparator	Other: placebo Patients will receive inhaled room air (21% inhaled oxygen) at a flow of 10L/minute via non-rebreather mask.

Eligibility

Ages Eligible for Study:	12 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant patients undergo scheduled or unscheduled cesarean section with regional anesthesia

Exclusion Criteria:

Urgent fetal or maternal indications for cesarean section precluding informed consent
Maternal oxygen saturations <95%
Non-reassuring fetal status
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: Christina Scifres, M.D.

(314)362-7300

scifresc@wudosis.wustl.edu

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 Foundation

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

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

Keywords provided by Washington University School of Medicine:

C-section
Surg Wound Infect

Study placed in the following topic categories:

Genital Diseases, Female
Endometritis
Postoperative Complications
Wounds and Injuries
Disorders of Environmental Origin

Uterine Diseases
Pelvic Inflammatory Disease
Surgical Wound Infection
Wound Infection

Additional relevant MeSH terms:

Pathologic Processes
Infection
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009