NCT00603603

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

January 17, 2008

Last Update Submit

June 20, 2016

Conditions

Infection; Cesarean SectionSurgical Wound InfectionEndometritis

Keywords

C-sectionSurg Wound Infect

Outcome Measures

Primary Outcomes (1)

  • Composite of Wound Infection and Endometritis

    4 weeks post-cesarean

Secondary Outcomes (4)

  • Maternal temperature greater than 38 degrees after the first 24 hours post-op

    4 weeks

  • Antibiotic usage greater than 24 hours post-op

    4 weeks

  • Wound opening greater than one centimeter for any cause

    4 weeks

  • Maternal hospital readmission

    4 weeks

Study Arms (2)

80% inhaled oxygen-non-rebreather

EXPERIMENTAL

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

30% inhaled oxygen-nasal cannula

ACTIVE COMPARATOR

2 liters of oxygen via nasal cannula (standard of care) during cesarean section only

Other: 30% inhaled oxygen via nasal cannula

Interventions

80% inhaled oxygen via non-rebreather maskOTHER

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.

80% inhaled oxygen-non-rebreather
30% inhaled oxygen via nasal cannulaOTHER

Patients randomized to treatment group will receive 30% inhaled oxygen via a nasal cannula (standard of care)during their cesarean section.

30% inhaled oxygen-nasal cannula

Eligibility Criteria

Age12 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant patients undergoing a scheduled or unscheduled cesarean section with regional anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital/Washington University School. of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384.

    PMID: 25004353DERIVED

MeSH Terms

Conditions

InfectionsSurgical Wound InfectionEndometritis

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Study Officials

  • David Stamilio, MD

    Washington University Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, OB/GYN

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 29, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)