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CompletedNCT03690271DOPABIEBUpdated Oct 1, 2018

Study PIEB vs PIEB: the Dose is it Variable According to the Patients

An observational study in Anesthesia, Epidural and Pregnancy, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-01.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
18 Years and older
Sex
Female
01

Study summary

the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.

Read the detailed description

In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.

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Conditions studied

  • Anesthesia, Epidural
  • Pregnancy
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In context

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Pregnant patient, during labor, for whom a PIEB is desired / programmed.

Inclusion criteria

  • Patient over 18 years old.
  • Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed.
  • Patient not objecting to their participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Hemostasis disorder contraindicated the epidural
  • Eclampsia
  • Caesarean section straightaway
  • Patient under legal protection (guardianship, curatorship, safeguard of justice).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (actual)
Patient registry
No

Groups and cohorts

  • Groupe 5-5

    Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 5 ml * dose to be administered every hour by the patient : 5 ml

  • groupe 6-6

    Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 6 ml * dose to be administered every hour by the patient : 6 ml

  • groupe 7-7

    Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way :7 ml * dose to be administered every hour by the patient :7 ml

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What researchers measure

Primary outcomes

  1. number of additional injections during work.

    Time frame: two days after infclusion

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Study locations

1 site
  • Centre Hospitalier Universitaire de Rennes
    Rennes, 35033, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03690271
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Oct 1, 2018
Start date
Dec 1, 2017
Primary completion
Jan 15, 2018
Completion
Jan 17, 2018
Last update
Oct 1, 2018

Study contacts

Eric WODEY, MD, PHD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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