NCT00876005

Brief Summary

This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,202

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4

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

Study Start

First participant enrolled

August 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 13, 2016

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

April 3, 2009

Last Update Submit

October 12, 2016

Conditions

Surgical Site Infection

Keywords

Wound infection

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

80% oxygen during cesarean section

Other: Oxygen by mask

2

ACTIVE COMPARATOR

30% oxygen during cesarean section

Other: Oxygen by mask

Interventions

Oxygen by maskOTHER

Postoperatively, an aerosol face mask is used to deliver oxygen at 80%

Also known as: Face mask delivery of supplemental oxygen at 80%
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mentally competent patients undergoing cesarean section under spinal or epidural anesthesia

You may not qualify if:

  • fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa clara Valley Medical Center

San Jose, California, 95128, United States

Location

Related Publications (1)

  • Duggal N, Poddatorri V, Noroozkhani S, Siddik-Ahmad RI, Caughey AB. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial. Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.

    PMID: 23743467DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionWound Infection

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neena Duggal, MD

    Santa Clara Valley Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

August 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 13, 2016

Record last verified: 2016-05

Locations

US(1)