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

NCT00603603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2016-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Infection; Cesarean Section
  • Surgical Wound Infection
  • Endometritis

Interventions

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.

Sponsors & Collaborators

  • Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • David Stamilio, MD · Washington University Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603603 on ClinicalTrials.gov