Labor PainNCT06094946
Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses
An observational study of Labor Pain, run by Women's Hospital HUS at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Ropivacaine Hydrocloride and Fentanyl Citrate
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2024to Feb 2025
- Phase
- Observational
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Contraindications for epidural analgesia
- Planned cesarean delivery
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump
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.
Read the detailed description
The purpose is to compare parturient and midwife satisfaction with the epidural labour analgesia when epidural analgesia is maintained by an epidural bolus pump (automated mandatory boluses with patient controlled boluses without background infusion) or midwife administered on-demand boluses.
- Conditions
- Labor Pain
- Being tested
- Ropivacaine Hydrocloride, Fentanyl Citrate
- Keywords
- epidural analgesia, labour epidural, patient controlled epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine HydroclorideDrug
1 mg/ml
Fentanyl CitrateDrug
2.5 micrograms/ml
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ropivacaine Hydrocloride; Drug: Fentanyl Citrate | |
| 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. Receives: Drug: Ropivacaine Hydrocloride; Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parturient satisfaction with analgesia
Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
Measured: During use of labour analgesia (up to 6 hours)
Secondary outcomes (2)
Midwife satisfaction with epidural labour analgesia
Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
Measured: During use of labour analgesia (up to 6 hours)
Support person's satisfaction with epidural labour analgesia
Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
Measured: During use of labour analgesia (up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital HUS
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Antti Vaananen, Helsinki University Central Hospital
- Investigators
- Riina Jernman, MD PhD, Study director, Helsinki University Hospital Women's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094946
- Sponsor's protocol ID
- PCEA_15102023
- Status last verified
- Apr 2024
- First submitted
- 16 Oct 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous data upon reasonable request with accepted study plan from an academic institution can be shared based on case-by-case assessment by the researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump
- ClinicalTrials.gov ID
- NCT06094946
- Acronym / sponsor ID
- PCEA_15102023
- Conditions
- Labor Pain
- Keywords
- epidural analgesia, labour epidural, patient controlled epidural
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Women's Hospital HUSUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
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.
Detailed description
The purpose is to compare parturient and midwife satisfaction with the epidural labour analgesia when epidural analgesia is maintained by an epidural bolus pump (automated mandatory boluses with patient controlled boluses without background infusion) or midwife administered on-demand boluses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midwife administered boluses | – | Drug: Ropivacaine Hydrocloride, Drug: Fentanyl CitrateThe 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 | – | Drug: Ropivacaine Hydrocloride, Drug: Fentanyl CitrateThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindications for epidural analgesia
- Planned cesarean delivery
- Age under 18 years
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 |
|---|---|---|
| Ropivacaine Hydrocloride1 mg/ml | Drug | Automated and parturient controlled epidural boluses, Midwife administered boluses |
| Fentanyl Citrate2.5 micrograms/ml | Drug | Automated and parturient controlled epidural boluses, Midwife administered boluses |
Primary outcome
Parturient satisfaction with analgesia
Time frame: During use of labour analgesia (up to 6 hours)
Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
2 secondary outcomes
Midwife satisfaction with epidural labour analgesia
Time frame: During use of labour analgesia (up to 6 hours)
Support person's satisfaction with epidural labour analgesia
Time frame: During use of labour analgesia (up to 6 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided. Anonymous data upon reasonable request with accepted study plan from an academic institution can be shared based on case-by-case assessment by the researchers
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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.
Riina Jernman, MD PhD study director
Helsinki University Hospital Women's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by Women's Hospital HUS at 1 site in Finland.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antti J Vaananen, MD PhD (+358504271850, antti.vaananen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parturient satisfaction with analgesia (time frame: During use of labour analgesia (up to 6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.