Wound Infection or Endometritis Post Cesarean SectionNCT00670020
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection
A study testing supplemental perioperative oxygen in people with Wound Infection or Endometritis Post Cesarean Section, run by University of Washington.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Wound Infection or Endometritis Post Cesarean Section
- What is being tested?
- supplemental perioperative oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- supplemental perioperative oxygen
- Keywords
- Women undergoing Cesarean section after the onset of labor
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplemental perioperative oxygenProcedure or surgery
increased perioperative oxygen verses non-interventional oxygen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | supplemental perioperative oxygen Receives: Procedure: supplemental perioperative oxygen |
| 2 | No intervention | Normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
Measured: within two weeks of cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startJan 2001
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection or Endometritis Post Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Carolyn M Gardella, MD, MPH, Principal investigator, University of Washington Dept of Ob/Gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670020
- Sponsor's protocol ID
- 18821
- Status last verified
- Apr 2008
- First submitted
- 29 Apr 2008
- Last updated
- 1 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection
- ClinicalTrials.gov ID
- NCT00670020
- Acronym / sponsor ID
- 18821
- Keywords
- Women undergoing Cesarean section after the onset of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: supplemental perioperative oxygensupplemental perioperative oxygen |
| 2 | No intervention | –Normal |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes
Key exclusion criteria (6 listed)
- Cesarean delivery prior to the onset of labor or rupture of membranes
- emergent cesarean delivery
- general endotracheal anesthesia
- clinical chorioamnionitis
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplemental perioperative oxygenincreased perioperative oxygen verses non-interventional oxygen | Procedure or surgery | 1 |
Primary outcome
surgical site infection
Time frame: within two weeks of cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn M Gardella, MD, MPH principal investigator
University of Washington Dept of Ob/Gyn
Questions about this trial
What is this clinical trial studying?
A study testing supplemental perioperative oxygen in people with Wound Infection or Endometritis Post Cesarean Section, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection (time frame: within two weeks of cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2008.