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Opioid Analgesic

Epidural Fentanyl for Labor Pain

Phase 4
Recruiting
Led By John Coffman, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Effective labor epidural analgesia with continuous epidural infusion established
A single vertex presentation fetus at term (38-42 weeks)
Must not have
Patients with history of spine abnormalities or spine surgery
Age less than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until delivery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if a higher dose of epidural fentanyl provides more pain relief during labor and delivery.

Who is the study for?
This trial is for first-time mothers in spontaneous labor, with a single baby in the correct head-down position at term (38-42 weeks), who can understand and agree to the study. They should have effective pain relief from an existing epidural but no chronic pain issues, allergies to opioids or local anesthetics, spine problems, or history of spine surgery.
What is being tested?
The study compares two doses of fentanyl given through an epidural during later stages of labor: a lower dose (20 mcg) versus a higher dose (100 mcg). The goal is to determine which dosage provides better pain relief during childbirth.
What are the potential side effects?
Possible side effects include nausea, itching, respiratory depression (slow breathing), drowsiness, and decreased blood pressure. These are common opioid-related side effects that may vary depending on the individual's reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an effective labor epidural in place.
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My baby is in the head-down position and I am 38-42 weeks pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had spine surgery or have spine abnormalities.
Select...
I am under 18 years old.
Select...
My labor epidural did not work well for pain relief.
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I have been pregnant more than once.
Select...
I am currently being treated for chronic pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during labor until post-partum day one
This trial's timeline: 3 weeks for screening, Varies for treatment, and during labor until post-partum day one for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse Events
Mode of Delivery
Patient Satisfaction
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose FentanylExperimental Treatment1 Intervention
High dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 100 mcg fentanyl (Fentanyl 100 mcg)
Group II: Low Dose FentanylActive Control1 Intervention
Low dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 20 mcg fentanyl (Fentanyl 20 mcg)

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,011 Total Patients Enrolled
1 Trials studying Labor Pain
50 Patients Enrolled for Labor Pain
John Coffman, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Fentanyl (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03120780 — Phase 4
Labor Pain Research Study Groups: Low Dose Fentanyl, High Dose Fentanyl
Labor Pain Clinical Trial 2023: Fentanyl Highlights & Side Effects. Trial Name: NCT03120780 — Phase 4
Fentanyl (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03120780 — Phase 4
~18 spots leftby Dec 2025
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