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

Phase 4

Completed

• Conditions: Laboring Women Requesting Neuraxial Labor Analgesia
• Interventions: Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

• Registration Number: NCT02008591
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-26
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2016-01-27
• Study Completion: 2016-01-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Technique	Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique	Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
Combined Spinal Epidural Technique	Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique	Bupivacaine 2.5 mg with Fentanyl 25 mcg
Dural Puncture Epidural Technique	Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique	Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States