NCT05255263

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

December 6, 2021

Last Update Submit

September 9, 2022

Conditions

Labor Onset and Length Abnormalities

Keywords

Cesarean DeliveryProgrammed Intermittent Epidural Bolus (PIEB)Continuous Epidural Infusion (CEI)Patient-Controlled Epidural Analgesia (PCEA)Normal Spontaneous Vaginal Delivery (NSVD)Instrumental Vaginal DeliverySecond Stage of Labor

Outcome Measures

Primary Outcomes (1)

  • Spontaneous Vaginal Delivery

    Rate of Spontaneous Vaginal Delivery (Percent of total deliveries)

    Delivery

Secondary Outcomes (12)

  • Cesarean Delivery

    Delivery

  • Instrumental Vaginal Delivery

    Delivery

  • Length of Second Stage

    During labor up to time of delivery

  • Failed Epidural

    During labor up to time of delivery

  • Local anesthetic concentration

    During labor up to time of delivery

  • +7 more secondary outcomes

Study Arms (2)

Programmed Intermittent Epidural Bolus

ACTIVE COMPARATOR

Intermittent epidural bolus as the first line labor epidural analgesia maintenance infusion

Other: PIEB

Continuous Epidural Infusion

ACTIVE COMPARATOR

Continuous epidural infusion as the first line labor epidural analgesia maintenance infusion

Other: CEI

Interventions

PIEBOTHER

Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia

Programmed Intermittent Epidural Bolus
CEIOTHER

Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia

Continuous Epidural Infusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Mission Bay

San Francisco, California, 94143, United States

Location

Related Publications (6)

  • George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.

    PMID: 23223119BACKGROUND

  • Xu J, Zhou J, Xiao H, Pan S, Liu J, Shang Y, Yao S. A Systematic Review and Meta-Analysis Comparing Programmed Intermittent Bolus and Continuous Infusion as the Background Infusion for Parturient-Controlled Epidural Analgesia. Sci Rep. 2019 Feb 22;9(1):2583. doi: 10.1038/s41598-019-39248-5.

    PMID: 30796286BACKGROUND

  • Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.

    PMID: 21788309BACKGROUND

  • McKenzie CP, Cobb B, Riley ET, Carvalho B. Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. Int J Obstet Anesth. 2016 May;26:32-8. doi: 10.1016/j.ijoa.2015.11.005. Epub 2015 Nov 27.

    PMID: 26775896BACKGROUND

  • Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.

    PMID: 27100210BACKGROUND

  • Onuoha OC. Epidural Analgesia for Labor: Continuous Infusion Versus Programmed Intermittent Bolus. Anesthesiol Clin. 2017 Mar;35(1):1-14. doi: 10.1016/j.anclin.2016.09.003. Epub 2016 Dec 12.

    PMID: 28131113BACKGROUND

Study Officials

  • Ronald B George, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Pragmatic, cluster-randomized, open-labeled, multiple-crossover trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

February 24, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)