Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery
The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study
1 other identifier
interventional
90
1 country
2
Brief Summary
The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2020
CompletedStudy Start
First participant enrolled
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 5, 2020
March 1, 2020
1.8 years
January 19, 2020
March 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
analgesic consumption
the amount of local anesthetic and opioid that required during labor
during the procedure/delivery
Secondary Outcomes (3)
pain intensity on a numerical rating scale (minimum=0, maximum=10)
during the procedure/delivery
duration of labor
until delivery
satisfaction on a numerical rating scale (minimum=0, maximum=10)
during the procedure/delivery
Study Arms (3)
epidural
ACTIVE COMPARATORcombined
ACTIVE COMPARATORdural puncture epidural
ACTIVE COMPARATORInterventions
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
Eligibility Criteria
You may qualify if:
- parturients requiring regional labor analgesia
- dilation less than 5cm
You may not qualify if:
- contraindication for regional technique
- refuse to participate
- language barriers
- obesity
- no pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aretaieio Hospital, University of Athens
Athens, Attica, 11528, Greece
Aretaieio Hospital
Athens, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 19, 2020
First Posted
March 2, 2020
Study Start
February 26, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 5, 2020
Record last verified: 2020-03