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

Not Applicable

Completed

• Conditions: Wound Infection or Endometritis Post Cesarean Section
• Interventions: Procedure: supplemental perioperative oxygen

• Registration Number: NCT00670020
• Lead Sponsor: University of Washington

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.

Detailed 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.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Last Update Submitted: 2008-04-30
• Study First Posted: 2008-05-01
• Last Update Posted: 2008-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	supplemental perioperative oxygen	supplemental perioperative oxygen

Primary Outcome Measures

Name	Time	Method
surgical site infection	within two weeks of cesarean section