ClinicalTrials.Veeva

Menu

Parturient Satisfaction With Epidural Analgesia by PCEA or Manual Boluses

W

Women's Hospital HUS

Status

Not yet enrolling

Conditions

Labor Pain

Treatments

Drug: Ropivacaine Hydrocloride
Drug: Fentanyl Citrate

Study type

Observational

Funder types

Other

Identifiers

NCT06094946
PCEA_15102023

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Midwife administered boluses
Description:
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
Treatment:
Drug: Fentanyl Citrate
Drug: Ropivacaine Hydrocloride
Automated and parturient controlled epidural boluses
Description:
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.
Treatment:
Drug: Fentanyl Citrate
Drug: Ropivacaine Hydrocloride

Trial contacts and locations

1

Loading...

Central trial contact

Antti J Vaananen, MD PhD; Riina Jernman, MD PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems