PregnancyEASNCT01235858
Aseptic Techniques During Epidural Analgesia in the Labor Floor
A study testing wearing of sterile gowns and No gown in people with Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- wearing of sterile gowns and No gown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Dec 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All pregnant women requesting epidural analgesia
Who cannot join
- Patients who have fever requiring antibiotics
- Patients who have received antibiotics in or within the previous 48 hours of labor
- Immuno-compromised patients.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Anesthesia Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
Official title: Responding to the ASRA (American Society of Regional Anesthesia) Challenge - Should Gowning be the Standard of Practice for Epidural Anesthesia: A Randomized Control Trial
There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure.
The purpose of this study is to compare two methods of aseptic technique for labor epidural insertion; a "conventional" method without wearing a sterile gown (free from living germs or microorganisms) versus strict aseptic method with wearing of sterile gowns.
It is our belief that there will be an increased contamination of epidural equipment and colonization of epidural catheter, secondary to bacterial fallout from the operators' bare hands in the group not wearing the sterile gowns.
Read the detailed description
At the present time there is no accepted standard for aseptic technique during insertion of an epidural catheter on the labor floor and what is considered to be essential is controversial. Recognizing this, the American Society of Regional Anesthesia (ASRA), the leading authority on regional anesthesia, established a task force to examine and establish guidelines for aseptic practice. Their findings highlighted the lack of good quality studies to support specific recommendations. This is especially true in regards to the use of sterile gowns during the performance of the procedure.
- Conditions
- Pregnancy
- Being tested
- wearing of sterile gowns, No gown
- Keywords
- Epidural analgesia, Epidural anesthesia labor, Aseptic technique, gown, no gown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing of sterile gownsProcedure or surgery
Also called Sterile gowns
Anesthesiologists wearing sterile gown for epidural insertion
No gownProcedure or surgery
Anesthesiologists not wearing sterile gown for epidural insertion
| Study group | Role | What they receive |
|---|---|---|
| Gown group | Other | Anesthesiologists wearing sterile gown for epidural insertion Receives: Procedure: wearing of sterile gowns |
| No Gown group | Other | Anesthesiologists not wearing gown for epidural insertion Receives: Procedure: No gown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.
Measured: one and one half year
Secondary outcomes (1)
length of epidural catheterization and positive culture
Measured: one year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Investigators
- Naveed T Siddiqui, MD, Principal investigator, Department of Anesthesia and Pain Management Mount Sinai Hospital, Toronto,Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235858
- Sponsor's protocol ID
- EAS-2009
- Acronym
- EAS
- Status last verified
- Jul 2011
- First submitted
- 27 Sep 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):520-4. doi: 10.1097/AAP.0000000000000171.
PubMed 25304478
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responding to the ASRA (American Society of Regional Anesthesia) Challenge - Should Gowning be the Standard of Practice for Epidural Anesthesia: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01235858
- Acronym / sponsor ID
- EAS / EAS-2009
- Conditions
- Pregnancy
- Keywords
- Epidural analgesia, Epidural anesthesia labor, Aseptic technique, gown, no gown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Nov 2010 (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.
There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure.
The purpose of this study is to compare two methods of aseptic technique for labor epidural insertion; a "conventional" method without wearing a sterile gown (free from living germs or microorganisms) versus strict aseptic method with wearing of sterile gowns.
It is our belief that there will be an increased contamination of epidural equipment and colonization of epidural catheter, secondary to bacterial fallout from the operators' bare hands in the group not wearing the sterile gowns.
Detailed description
At the present time there is no accepted standard for aseptic technique during insertion of an epidural catheter on the labor floor and what is considered to be essential is controversial. Recognizing this, the American Society of Regional Anesthesia (ASRA), the leading authority on regional anesthesia, established a task force to examine and establish guidelines for aseptic practice. Their findings highlighted the lack of good quality studies to support specific recommendations. This is especially true in regards to the use of sterile gowns during the performance of the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gown group | Other | Procedure: wearing of sterile gownsAnesthesiologists wearing sterile gown for epidural insertion |
| No Gown group | Other | Procedure: No gownAnesthesiologists not wearing gown for epidural insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women requesting epidural analgesia
Key exclusion criteria (3 listed)
- Patients who have fever requiring antibiotics
- Patients who have received antibiotics in or within the previous 48 hours of labor
- Immuno-compromised patients.
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 |
|---|---|---|
| wearing of sterile gownsAlso: Sterile gownsAnesthesiologists wearing sterile gown for epidural insertion | Procedure or surgery | Gown group |
| No gownAnesthesiologists not wearing sterile gown for epidural insertion | Procedure or surgery | No Gown group |
Primary outcome
Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.
Time frame: one and one half year
1 secondary outcome
length of epidural catheterization and positive culture
Time frame: one year and a half
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 4 Apr 2012.
- Derived from this study: PubMed 25304478Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):520-4. doi: 10.1097/AAP.0000000000000171.
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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.
Naveed T Siddiqui, MD principal investigator
Department of Anesthesia and Pain Management Mount Sinai Hospital, Toronto,Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearing of sterile gowns and No gown in people with Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 3 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 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter. (time frame: one and one half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235858, which also lists 1 linked publication.
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 4 Apr 2012.