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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05255263
Other study ID # GLEAM
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2022

Study information

Verified date September 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
PIEB
Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia
CEI
Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia

Locations

Country Name City State
United States UCSF Mission Bay San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. Review. Erratum in: Anesth Analg. 2013 Jun;116(6):1385. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

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