Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Laboring Women Requesting Neuraxial Labor Analgesia
• Intervention / Treatment: Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural Technique; Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique; Three different techniques, using the same medications (bupivacaine and fentanyl)
Active Comparator: Combined Spinal Epidural Technique; Bupivacaine 2.5 mg with Fentanyl 25 mcg	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique; Three different techniques, using the same medications (bupivacaine and fentanyl)
Active Comparator: Dural Puncture Epidural Technique; Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique; Three different techniques, using the same medications (bupivacaine and fentanyl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Outcomes	Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis.	Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Outcomes	Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns	Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Lawrence C Tsen, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2013
• Primary Completion (Actual): January 27, 2016
• Study Completion (Actual): January 27, 2016

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Neuraxial Technique; Epidural Technique; Dural Puncture Epidural Technique; Combined Spinal Epidural Technique; Labor Analgesia; Obstetric
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 2013P001927

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No