NCT00670020

Brief Summary

The purpose of this study is to determine whether supplemental perioperative oxygen significantly decreases the incidence of post-Cesarean endometritis and wound infection among women who undergo Cesarean section after the onset of labor.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2001

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
Last Updated

May 1, 2008

Status Verified

April 1, 2008

Enrollment Period

5.9 years

First QC Date

April 29, 2008

Last Update Submit

April 30, 2008

Conditions

Wound Infection or Endometritis Post Cesarean Section

Keywords

Women undergoing Cesarean section after the onset of labor

Outcome Measures

Primary Outcomes (1)

  • surgical site infection

    within two weeks of cesarean section

Study Arms (2)

1

EXPERIMENTAL

supplemental perioperative oxygen

Procedure: supplemental perioperative oxygen

2

NO INTERVENTION

Normal

Interventions

supplemental perioperative oxygenPROCEDURE

increased perioperative oxygen verses non-interventional oxygen

1

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes

You may not qualify if:

  • Cesarean delivery prior to the onset of labor or rupture of membranes
  • emergent cesarean delivery
  • general endotracheal anesthesia
  • clinical chorioamnionitis
  • HIV infection
  • less than 16 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Carolyn M Gardella, MD, MPH

    University of Washington Dept of Ob/Gyn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

January 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 1, 2008

Record last verified: 2008-04