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Intrapartum Epidural Catheter Displacement: Dressing Methods

NCT03574441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-07-30

Study results available
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Summary

Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. It has been argued that prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed epidurals in obstetrics.

Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.

Conditions

  • Analgesia, Obstetrical

Interventions

DEVICE

Tegaderm dressing + catheter support pad

Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter

DEVICE

Tegaderm dressing + Steri-strip dressing

Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter

DEVICE

Tegaderm dressing only

Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2018-03-11
Completion
2018-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574441 on ClinicalTrials.gov