Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

NCT ID: NCT06094946

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-02-28

Brief Summary

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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

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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

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Labor Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Ropivacaine Hydrocloride

Intervention Type DRUG

1 mg/ml

Fentanyl Citrate

Intervention Type DRUG

2.5 micrograms/ml

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.

Ropivacaine Hydrocloride

Intervention Type DRUG

1 mg/ml

Fentanyl Citrate

Intervention Type DRUG

2.5 micrograms/ml

Interventions

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Ropivacaine Hydrocloride

1 mg/ml

Intervention Type DRUG

Fentanyl Citrate

2.5 micrograms/ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Contraindications for epidural analgesia
* Planned cesarean delivery
* Age under 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Women's Hospital HUS

OTHER

Sponsor Role lead

Responsible Party

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Antti Vaananen

Anesthesiologist MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riina Jernman, MD PhD

Role: STUDY_DIRECTOR

Helsinki University Hospital Women's hospital

Locations

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HUS/Women's hospital dept of anaesthesia

Helsinki, , Finland

Site Status

Countries

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Finland

Central Contacts

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Antti J Vaananen, MD PhD

Role: CONTACT

+358504271850

Riina Jernman, MD PhD

Role: CONTACT

+358504272584

Other Identifiers

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PCEA_15102023

Identifier Type: -

Identifier Source: org_study_id

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