ClinicalTrials.Veeva

Menu

Aseptic Techniques During Epidural Analgesia in the Labor Floor (EAS)

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Conditions

Pregnancy

Treatments

Procedure: No gown
Procedure: wearing of sterile gowns

Study type

Interventional

Funder types

Other

Identifiers

NCT01235858
EAS-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All pregnant women requesting epidural analgesia

Exclusion criteria

  • Patients who have fever requiring antibiotics
  • Patients who have received antibiotics in or within the previous 48 hours of labor
  • Immuno-compromised patients.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

240 participants in 2 patient groups

Gown group
Other group
Description:
Anesthesiologists wearing sterile gown for epidural insertion
Treatment:
Procedure: wearing of sterile gowns
No Gown group
Other group
Description:
Anesthesiologists not wearing gown for epidural insertion
Treatment:
Procedure: No gown

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems