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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of needle passes
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,274 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
~133 spots leftby Dec 2025
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