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NCT02949271 · ClinicalTrials.gov registry record · Phase 4

Comparison of PIEB vs CEI for Labor Analgesia

A Phase 4 study of Labor Pain, sponsored by Duke University.

Completed
Registry status
Phase 4
Development phase
179
Enrollment target
1
Study location

NCT02949271 is a Phase 4 study of Labor Pain that has completed, run by Duke University. The registered enrollment target is 179 participants, roughly in line with the 191-participant average among 14 other Labor Pain trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT02949271, a Phase 4 study of Labor Pain, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 4
Development phase
179 participants
Enrollment target
1
Study location

Study Summary

The aim of this prospective, doubled-blinded randomized study is to compare two modes of epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing, for providing labor epidural analgesia. The primary outcome will be the volume of local anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus, labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of successful to unsuccessful attempts, frequency of hypotension, duration of first and second stages of labor and level of patient satisfaction. The investigator plans to enroll 120 nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1% with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be analyzed using Chi-square test or Fisher's exact test as appropriate.

Conditions Studied

Labor Pain

Interventions

  • DRUG Ropivacaine
  • DRUG Fentanyl
  • OTHER Programmed Intermittent Epidural Bolus
  • OTHER Continuous Epidural Infusion

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2016-11-08
Est. Completion 2017-11-01
Phase Phase 4

Sponsor

Duke University

1,725 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02949271

The ClinicalTrials.gov registry entry for NCT02949271 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 191-participant average among 14 other Labor Pain trials with a reported enrollment target. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Labor Pain appearing as the primary indexed condition, and to 4 interventions - of which Ropivacaine is the first listed.

NCT02949271 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT02949271 about?

NCT02949271 is a clinical study titled "Comparison of PIEB vs CEI for Labor Analgesia". The aim of this prospective, doubled-blinded randomized study is to compare two modes of epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing, for providing labor epidural analg...

What is the current status of trial NCT02949271?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 179 participants. The study started on 2016-11-08. Estimated completion is 2017-11-01.

What conditions does trial NCT02949271 study?

This clinical trial studies the following conditions: Labor Pain.

What interventions are being tested in trial NCT02949271?

The interventions under investigation include: Ropivacaine (DRUG), Fentanyl (DRUG), Programmed Intermittent Epidural Bolus (OTHER), Continuous Epidural Infusion (OTHER).

Who is sponsoring clinical trial NCT02949271?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02949271 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.