NCT03596333

Brief Summary

Color Flow Doppler (CFD) utilizes Doppler information obtained from signals sent to and received from a transducer. This information is color-encoded and then displayed as color on an overlay of the two-dimensional image. The color scale represents both speed and direction of flow within a discrete area of the image. CFD has been recently used to determine the position of the epidural catheter. However its role in labor epidural has yet to be defined. This study describes the use of CFD to confirm the position of the tip of the epidural needle in the context of labor analgesia. This study hypothesized that CFD is a feasible method for identifying proper epidural needle placement prior to epidural catheter advancement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

July 12, 2018

Last Update Submit

July 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Epidural needle tip position

    Identification of posterior complex (dura and ligamentum flavum with color flow Doppler

    5 minutes (from insertion of epidural needle until identification of position)

Secondary Outcomes (2)

  • Epidural catheter position

    5 minutes (from advancement of epidural catheter until identification of position)

  • Epidural failure rate

    12 hours (labor duration)

Interventions

We conducted a retrospective chart review to evaluate the stored ultrasound images used during labor epidural placement, as well as demographic and anesthetic variables.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Term pregnant patients who underwent labor epidural assisted with ultrasound

You may qualify if:

  • Pregnant patients who had labor epidural placed for clinical indications, in whom ultrasound was used to assist the procedure.

You may not qualify if:

  • Poor quality ultrasound images judged by experienced anesthesiologist
  • Patients with history of lumbar spine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Efrain Riveros Perez, MD

    Medical College of Georgia. Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Anesthesiology and Perioperative Medicine

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 23, 2018

Study Start

May 28, 2018

Primary Completion

June 28, 2018

Study Completion

June 30, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations