Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

Wound Infection or Endometritis Post Cesarean Section Clinical Trial

Official title:

Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670020
• Other study ID #: 18821
• Status: Completed
• Phase: N/A
• First received: April 29, 2008
• Last updated: April 30, 2008
• Start date: January 2001
• Est. completion date: December 2006

Study information

• Verified date: April 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Women undergoing cesarean section after rupture of membranes or onset of labor are randomized in a one to one ratio to either normal or supplemental perioperative oxygen during cesarean section and for two hours afterwards.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometritis
• Infection
• Wound Infection
• Wound Infection or Endometritis Post Cesarean Section

Intervention

Procedure:
• supplemental perioperative oxygen
increased perioperative oxygen verses non-interventional oxygen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical site infection		within two weeks of cesarean section	No