← Back to Search

Ultrasound-Guided Epidurals for Labor Analgesia

N/A

Waitlist Available

Led By Antonio Gonzalez, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 - 20 minutes after epidural placement

Awards & highlights

Study Summary

This trial compares effects of traditional vs automated ultrasound guidance for labor epidurals done by inexperienced sonographers. Outcome: number of needle passes.

Who is the study for?

This trial is for individuals classified as ASA-1, ASA-2, or ASA-3 who need labor epidural analgesia. They should have no back deformities, be able to sit upright for the procedure, and not have had lumbar surgery before. Also, they mustn't be allergic to ultrasound gel.Check my eligibility

What is being tested?

The study compares needle guidance in labor epidurals between a traditional handheld ultrasound device and an automated one when used by sonographers with less than a year of experience. The main focus is on how many times the needle has to pass.See study design

What are the potential side effects?

Since this trial focuses on comparing devices rather than drugs or invasive procedures, side effects are minimal and primarily related to potential discomfort from multiple needle passes during epidural placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 - 20 minutes after epidural placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 - 20 minutes after epidural placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 - 20 minutes after epidural placement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of needle passes

Secondary outcome measures

Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance

Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance

Number of Needle attempts

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Handheld Automated ultrasoundExperimental Treatment1 Intervention

Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.

Group II: Handheld traditional ultrasoundActive Control1 Intervention

Traditional US will be used to compare number of needle manipulations to the handheld US.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,468 Total Patients Enrolled

Antonio Gonzalez, MDPrincipal InvestigatorYale University

2 Previous Clinical Trials

360 Total Patients Enrolled

Media Library

Labor Analgesia Research Study Groups: Handheld traditional ultrasound, Handheld Automated ultrasound

Labor Analgesia Clinical Trial 2023: Automated Ultrasound Highlights & Side Effects. Trial Name: NCT05909085 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accommodate individuals older than 65 years of age?

"This trial is accepting patients that are between the age of majority and 45 years old."

Answered by AI

What qualifications must potential participants possess in order to take part in this clinical trial?

"Acceptance to this trial is contingent upon laboring participants aged 18-45. The total amount of candidates admitted into the study will be 200 in aggregate."

Answered by AI

Are there still vacancies for participants in this clinical trial?

"Information on clinicaltrials.gov shows that this particular trial, which was first published July 1st 2023, is not presently recruiting patients. However, two other studies are actively enrolling volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device

2024. "The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05909085.