Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses
1 other identifier
observational
100
1 country
1
Brief Summary
Those prospective parturients that express that they may want an epidural labour analgesia for their delivery will be informed about the possibility to choose between a pump driven epidural or midwife administered intermittent boluses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2024
Shorter than P25 for all trials
1 active site
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
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedApril 24, 2024
April 1, 2024
2 months
October 16, 2023
April 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parturient satisfaction with analgesia
Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
During use of labour analgesia (up to 6 hours)
Secondary Outcomes (2)
Midwife satisfaction with epidural labour analgesia
During use of labour analgesia (up to 6 hours)
Support person's satisfaction with epidural labour analgesia
During use of labour analgesia (up to 6 hours)
Study Arms (2)
Midwife administered boluses
The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued on-demand by similar boluses until delivery
Automated and parturient controlled epidural boluses
The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued by automated boluses of the same solution (6ml every 40 minutes) with possibility for the parturient to administer 6 ml extra doses with a 20 minute lock-out. Maximum hourly dose 20 ml.
Interventions
1 mg/ml
2.5 micrograms/ml
Eligibility Criteria
Parturients coming to the delivery hospital (a tertiary delivery hospital with 8000 deliveries per year and 85 % epidural rate) for intended vaginal delivery and requesting epidural analgesia
You may qualify if:
- Age 18 years or older
- Admitted to the delivery hospital with the prospect of vaginal delivery
- On admission when questioned about planned analgesia expresses that may want an epidural analgesia for the planned vaginal delivery
- After reading the study prochure signs the participation (consent) form
- Sufficient command of Finnish or Swedish to facilitate interview
You may not qualify if:
- Contraindications for epidural analgesia
- Planned cesarean delivery
- Age under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women's Hospital HUSlead
- Helsinki University Central Hospitalcollaborator
Study Sites (1)
HUS/Women's hospital dept of anaesthesia
Helsinki, 00029, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Riina Jernman, MD PhD
Helsinki University Hospital Women's hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist MD PhD
Study Record Dates
First Submitted
October 16, 2023
First Posted
October 23, 2023
Study Start
December 1, 2024
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
April 24, 2024
Record last verified: 2024-04