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Warmed Epidural Medication for Labor Pain Management
N/A
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
Women with a single vertex presentation fetus at term (38-42 weeks)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights
Study Summary
This trial will study whether warming epidural medications help with the pain of labor and make it start sooner.
Who is the study for?
This trial is for women at term (38-42 weeks) with a single baby in head-down position, who want an epidural for labor pain relief. They must understand English and give written consent. It's not for those under 18, with spine issues, fever, infection signs, or allergies to pain meds.Check my eligibility
What is being tested?
The study is testing if warming up the medication used in epidurals can speed up pain relief during labor. Women will either get their epidural medication warmed ('Pocket-warming') or receive the standard care without warming.See study design
What are the potential side effects?
Epidural medications may cause side effects like low blood pressure, backache, headache, or temporary soreness where the needle goes in. Warming the medication isn't expected to add risks but it's being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant with one baby in the head-down position, due between 38-42 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of labor and delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of labor and delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time until pain score less than or equal to 3
Secondary outcome measures
Breakthrough pain
Labor analgesia satisfaction
Mode of delivery
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pocket-warmed epidural medicationExperimental Treatment1 Intervention
This arm will consist of pocket-warmed epidural medications to be administered per standard protocol to patients randomized to this group; this group is the pocket-warming group.
Group II: Room-temperature epidural medicationActive Control1 Intervention
This arm will consist of room-temperature epidural medications to be administered per standard protocol to patients randomized to this group. This group has no experimental intervention; standard of care labor epidural.
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
823 Previous Clinical Trials
501,053 Total Patients Enrolled
John Coffman, MDPrincipal Investigator - The Ohio State University Wexner Medical Center
Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have an epidural during labor due to health reasons.I have had spine surgery or spine problems in the past.I am pregnant with one baby in the head-down position, due between 38-42 weeks.I am under 18 years old.I want an epidural for pain relief during labor.I am showing signs or feeling symptoms of an infection.I am currently being treated for chronic pain.
Research Study Groups:
This trial has the following groups:- Group 1: Pocket-warmed epidural medication
- Group 2: Room-temperature epidural medication
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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