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CompletedNCT02008591Updated Jan 24, 2017

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

A Phase 4 interventional study of Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique in Laboring Women Requesting Neuraxial Labor Analgesia, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-01-24.

Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

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Conditions studied

  • Laboring Women Requesting Neuraxial Labor Analgesia

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Keywords

  • Neuraxial Technique
  • Epidural Technique
  • Dural Puncture Epidural Technique
  • Combined Spinal Epidural Technique
  • Labor Analgesia
  • Obstetric
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In context

Labor Pain

395 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 325 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
  1. Evidence of anticipated fetal anomalies
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • ProcedureEpidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

    Three different techniques, using the same medications (bupivacaine and fentanyl)

06

What researchers measure

Primary outcomes

  1. Maternal Outcomes

    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 outcomes

  1. Fetal Outcomes

    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

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Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02008591
Lead sponsor
Brigham and Women's Hospital
Responsible party
Lawrence Ching Tsen (Associate Professor, Harvard Medical School, Brigham and Women's Hospital) — Principal investigator
First posted
Dec 11, 2013
Start date
Nov 26, 2013
Primary completion
Jan 27, 2016
Completion
Jan 27, 2016
Last update
Jan 24, 2017

Study contacts

Lawrence C Tsen, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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