Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women
NCT ID: NCT03712735
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
390 participants
INTERVENTIONAL
2018-10-23
2021-03-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 2.5ml of Bupivacaine 0.25% Plus Fentanyl 8 mcg/ml
NCT03735771
Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia
NCT03730753
A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
NCT03871530
Programmed Intermittent Epidural Bolus Time Interval and Injection Volume
NCT00417027
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor 2
NCT02758405
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings:
PIEB flow rate = high; interval = 60 min
Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Group B
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min
Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Group C
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min
Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bupivacaine 0.08% - fentanyl 2mcg
In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \</= 5cm cervical dilation at the time of epidural anesthesia request
* ASA 2-3 patients aged 19 or over who are able to provide informed consent
Exclusion Criteria
* History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
* Current or historical evidence of any significant medical conditions
* Clinical settings in which continuous epidural infusion may be preferable
* Risk factors significantly increasing the need for Cesarean delivery
* Anticipated fetal abnormalities
19 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anthony Chau
Clinical Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anton Chau, MD MMSc
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BC Women's Hospital
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H18-02318
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.