Back to resultsComparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
Primary Purpose
Laboring Women Requesting Neuraxial Labor Analgesia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
Sponsored by
About this trial
This is an interventional treatment trial for Laboring Women Requesting Neuraxial Labor Analgesia focused on measuring Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Combined Spinal Epidural Technique, Labor Analgesia, Obstetric
Eligibility Criteria
Inclusion Criteria:
- 1. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia
Exclusion Criteria:
- 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery.
5. Evidence of anticipated fetal anomalies
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Epidural Technique
Combined Spinal Epidural Technique
Dural Puncture Epidural Technique
Arm Description
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
Bupivacaine 2.5 mg with Fentanyl 25 mcg
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
Outcomes
Primary Outcome Measures
Maternal Outcomes
Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis.
Secondary Outcome Measures
Fetal Outcomes
Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns
Full Information
NCT ID
NCT02008591
First Posted
November 26, 2013
Last Updated
January 20, 2017
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02008591
Brief Title
Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
Official Title
Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 26, 2013 (Actual)
Primary Completion Date
January 27, 2016 (Actual)
Study Completion Date
January 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief.
The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laboring Women Requesting Neuraxial Labor Analgesia
Keywords
Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Combined Spinal Epidural Technique, Labor Analgesia, Obstetric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Anesthesiologist performing technique and bedside nurse instructed not to reveal randomization arm to the patient or study co-investigator who was waiting outside the room, and notified only after completion of the neuraxial placement protocol.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural Technique
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
Arm Title
Combined Spinal Epidural Technique
Arm Type
Active Comparator
Arm Description
Bupivacaine 2.5 mg with Fentanyl 25 mcg
Arm Title
Dural Puncture Epidural Technique
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
Intervention Type
Procedure
Intervention Name(s)
Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
Intervention Description
Three different techniques, using the same medications (bupivacaine and fentanyl)
Primary Outcome Measure Information:
Title
Maternal Outcomes
Description
Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis.
Time Frame
Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Secondary Outcome Measure Information:
Title
Fetal Outcomes
Description
Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns
Time Frame
Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia
Exclusion Criteria:
- 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery.
5. Evidence of anticipated fetal anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence C Tsen, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
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