Labor Onset and Length AbnormalitiesGLEAMNCT05255263
Goal-directed Labor Epidural Analgesia Maintenance
A study testing PIEB and CEI in people with Labor Onset and Length Abnormalities, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities
- What is being tested?
- PIEB and CEI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Requests labor epidural analgesia requiring epidural maintenance with local anesthesia and opioid for planned vaginal delivery
Who cannot join
- Planned cesarean delivery
- Planned operative vaginal delivery
- Epidural time (placement to delivery) < 1 hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Labor Onset and Length Abnormalities
- Being tested
- PIEB, CEI
- Keywords
- Cesarean Delivery, Programmed Intermittent Epidural Bolus (PIEB), Continuous Epidural Infusion (CEI), Patient-Controlled Epidural Analgesia (PCEA), Normal Spontaneous Vaginal Delivery (NSVD), Instrumental Vaginal Delivery, Second Stage of Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIEBOther
Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia
CEIOther
Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia
| Study group | Role | What they receive |
|---|---|---|
| Programmed Intermittent Epidural Bolus | Active comparator | Intermittent epidural bolus as the first line labor epidural analgesia maintenance infusion Receives: Other: PIEB |
| Continuous Epidural Infusion | Active comparator | Continuous epidural infusion as the first line labor epidural analgesia maintenance infusion Receives: Other: CEI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Vaginal Delivery
Rate of Spontaneous Vaginal Delivery (Percent of total deliveries)
Measured: Delivery
Secondary outcomes (12)
Cesarean Delivery
Rate of Cesarean Delivery (Percent of total deliveries)
Measured: Delivery
Instrumental Vaginal Delivery
Rate of Instrumental Vaginal Delivery (Percent of total deliveries)
Measured: Delivery
Length of Second Stage
Length of Second Stage of Labor (hours)
Measured: During labor up to time of delivery
Failed Epidural
Rate of Failed Epidural, requiring general anesthesia or epidural replacement. (Percent of total labor epidural anesthetics)
Measured: During labor up to time of delivery
Local anesthetic concentration
Local anesthetic concentration (Percent solution)
Measured: During labor up to time of delivery
Epidural opioids used
Epidural opioid (identity of opioid)
Measured: During labor up to time of delivery
Epidural opioids used
Epidural opioid concentration (µg/mL)
Measured: During labor up to time of delivery
CEI rate
Continuous Epidural Infusion Rate (mL/hr)
Measured: During labor up to time of delivery
PIEB Volume
Programmed Intermittent Epidural Bolus Volume (mL)
Measured: During labor up to time of delivery
PIEB Interval
Programmed Intermittent Epidural Bolus (minutes)
Measured: During labor up to time of delivery
PCEA Volume
Patient-Controlled Epidural Analgesia bolus volume (mL)
Measured: During labor up to time of delivery
PCEA Lockout
Patient-Controlled Epidural Analgesia lockout time (minutes)
Measured: During labor up to time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: Study is currently on hold, pending further evaluation and coordination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Labor Onset and Length AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, cluster-randomized, open-labeled, multiple-crossover trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald B George, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255263
- Sponsor's protocol ID
- GLEAM
- Acronym
- GLEAM
- Status last verified
- Sep 2022
- First submitted
- 6 Dec 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23223119Xu 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.
PubMed 30796286Capogna 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.
PubMed 21788309McKenzie 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.
PubMed 26775896Tien 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.
PubMed 27100210Onuoha 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.
PubMed 28131113
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus vs. Continuous Epidural Infusion: a Multicenter, Pragmatic, Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT05255263
- Acronym / sponsor ID
- GLEAM / GLEAM
- Conditions
- Labor Onset and Length Abnormalities
- Keywords
- Cesarean Delivery, Programmed Intermittent Epidural Bolus (PIEB), Continuous Epidural Infusion (CEI), Patient-Controlled Epidural Analgesia (PCEA), Normal Spontaneous Vaginal Delivery (NSVD), Instrumental Vaginal Delivery, Second Stage of Labor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is currently on hold, pending further evaluation and coordination.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, cluster-randomized, open-labeled, multiple-crossover trial
| Arm | Type | Receives |
|---|---|---|
| Programmed Intermittent Epidural Bolus | Active comparator | Other: PIEBIntermittent epidural bolus as the first line labor epidural analgesia maintenance infusion |
| Continuous Epidural Infusion | Active comparator | Other: CEIContinuous epidural infusion as the first line labor epidural analgesia maintenance infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requests labor epidural analgesia requiring epidural maintenance with local anesthesia and opioid for planned vaginal delivery
Key exclusion criteria (3 listed)
- Planned cesarean delivery
- Planned operative vaginal delivery
- Epidural time (placement to delivery) < 1 hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIEBProgrammed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia | Other | Programmed Intermittent Epidural Bolus |
| CEIContinuous Epidural Infusion with Patient-Controlled Epidural Analgesia | Other | Continuous Epidural Infusion |
Primary outcome
Spontaneous Vaginal Delivery
Time frame: Delivery
Rate of Spontaneous Vaginal Delivery (Percent of total deliveries)
12 secondary outcomes
Cesarean Delivery
Time frame: Delivery
Instrumental Vaginal Delivery
Time frame: Delivery
Length of Second Stage
Time frame: During labor up to time of delivery
Failed Epidural
Time frame: During labor up to time of delivery
Local anesthetic concentration
Time frame: During labor up to time of delivery
Epidural opioids used
Time frame: During labor up to time of delivery
Epidural opioids used
Time frame: During labor up to time of delivery
CEI rate
Time frame: During labor up to time of delivery
PIEB Volume
Time frame: During labor up to time of delivery
PIEB Interval
Time frame: During labor up to time of delivery
PCEA Volume
Time frame: During labor up to time of delivery
PCEA Lockout
Time frame: During labor up to time of delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 23223119George 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.
- Background: PubMed 30796286Xu 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.
- Background: PubMed 21788309Capogna 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.
- Background: PubMed 26775896McKenzie 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.
- Background: PubMed 27100210Tien 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.
- Background: PubMed 28131113Onuoha 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.
- Individual participant dataSharing planned: No
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald B George, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIEB and CEI in people with Labor Onset and Length Abnormalities, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Vaginal Delivery (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255263, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.