Goal-directed Labor Epidural Analgesia Maintenance (GLEAM)

September 9, 2022 updated by: University of California, San Francisco

Programmed Intermittent Epidural Bolus vs. Continuous Epidural Infusion: a Multicenter, Pragmatic, Cluster-randomized Trial

The GLEAM trial is a multicenter, pragmatic, cluster-randomized trial to assess the effects of programmed intermittent epidural bolus versus continuous epidural infusion on the rate of spontaneous vaginal delivery and several other clinically-relevant outcomes.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: The goal of Labor Epidural Analgesia (LEA) to provide optimal analgesia while limiting any impact on the course of labor. Until recently, the most common technique for epidural analgesia was a combination of continuous epidural infusion (CEI) and patient controlled epidural analgesia (PCEA). CEI delivers an infusion of local anesthetic into the epidural space at a constant rate. Programmed intermittent epidural bolus (PIEB)-a more recently-developed alternative to CEI-delivers intermittent boluses of local anesthetic into the epidural space at scheduled time intervals.

A series of randomized control trials (RCT) have compared PIEB and CEI with overall results favoring PIEB for superior analgesia. However, CEI has been shown to be associated with an increased amount of local anesthetic consumption, which may increase the degree of motor blockade, placing parturients at higher risk for instrumental and cesarean deliveries. Studies to date have offered conflicting conclusions on whether CEI is associated with a reduced rates of normal spontaneous vaginal delivery (NSVD).

AIM: The GLEAM trial aims to investigate the hypothesis that PIEB will have higher rates of NSVD than CEI. The effects of CEI vs. PIEB on cesarean delivery rate, instrumental vaginal delivery rate, length of second stage of labor, failed epidural rate.

TRIAL DESIGN: Multi-center, pragmatic, cluster-randomized trial

  • Centers will be assigned to use either PIEB or CEI for the first-line labor epidural analgesia maintenance infusion for clusters of minimum one month duration
  • Participating institutions will be recruited via the Society for Obstetric Anesthesia and Perinatology (SOAP) Research Network
  • Centers must use an epidural solution with a low concentration of local anesthesia with an opioid.
  • Both PIEB and CEI must include PCEA - rates and volumes are determined by the institution
  • Neuraxial anesthesia can be initiated with Dural Puncture Epidural (DPE), Combined Spinal Epidural (CSE) or epidural bolus
  • Our sample will consist of all women, at least 18 years of age, who were admitted to the labour & delivery ward for planned vaginal delivery and had neuraxial analgesia
  • Data will be collected in routine clinical care and automatically extracted from the electronic health record (EHR)

PARTICIPATING SITE CRITERIA:

  • Routinely provided LEA with Ropivacaine ≤ 0.125% or Bupivacaine ≤ 0.1% epidural solutions with fentanyl (1-3 mcg/ml)
  • Can provide LEA with PIEB or CEI
  • Must include PCEA as part of all LEA regardless of PIEB or CEI

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Mission Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Requests labor epidural analgesia requiring epidural maintenance with local anesthesia and opioid for planned vaginal delivery

Exclusion Criteria:

  • Planned cesarean delivery
  • Planned operative vaginal delivery
  • Epidural time (placement to delivery) < 1 hour

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Programmed Intermittent Epidural Bolus
Intermittent epidural bolus as the first line labor epidural analgesia maintenance infusion
Other: PIEB
Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia
Active Comparator: Continuous Epidural Infusion
Continuous epidural infusion as the first line labor epidural analgesia maintenance infusion
Other: CEI
Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous Vaginal Delivery
Time Frame: Delivery
Rate of Spontaneous Vaginal Delivery (Percent of total deliveries)
Delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean Delivery
Time Frame: Delivery
Rate of Cesarean Delivery (Percent of total deliveries)
Delivery
Instrumental Vaginal Delivery
Time Frame: Delivery
Rate of Instrumental Vaginal Delivery (Percent of total deliveries)
Delivery
Length of Second Stage
Time Frame: During labor up to time of delivery
Length of Second Stage of Labor (hours)
During labor up to time of delivery
Failed Epidural
Time Frame: During labor up to time of delivery
Rate of Failed Epidural, requiring general anesthesia or epidural replacement. (Percent of total labor epidural anesthetics)
During labor up to time of delivery
Local anesthetic concentration
Time Frame: During labor up to time of delivery
Local anesthetic concentration (Percent solution)
During labor up to time of delivery
Epidural opioids used
Time Frame: During labor up to time of delivery
Epidural opioid (identity of opioid)
During labor up to time of delivery
Epidural opioids used
Time Frame: During labor up to time of delivery
Epidural opioid concentration (µg/mL)
During labor up to time of delivery
CEI rate
Time Frame: During labor up to time of delivery
Continuous Epidural Infusion Rate (mL/hr)
During labor up to time of delivery
PIEB Volume
Time Frame: During labor up to time of delivery
Programmed Intermittent Epidural Bolus Volume (mL)
During labor up to time of delivery
PIEB Interval
Time Frame: During labor up to time of delivery
Programmed Intermittent Epidural Bolus (minutes)
During labor up to time of delivery
PCEA Volume
Time Frame: During labor up to time of delivery
Patient-Controlled Epidural Analgesia bolus volume (mL)
During labor up to time of delivery
PCEA Lockout
Time Frame: During labor up to time of delivery
Patient-Controlled Epidural Analgesia lockout time (minutes)
During labor up to time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Ronald B George, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLEAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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