NCT03690271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 21, 2018

Last Update Submit

September 27, 2018

Conditions

Anesthesia, EpiduralPregnancy

Outcome Measures

Primary Outcomes (1)

  • number of additional injections during work.

    two days after infclusion

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Study Officials

  • Eric WODEY, MD, PHD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

October 1, 2018

Study Start

December 1, 2017

Primary Completion

January 15, 2018

Study Completion

January 17, 2018

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

FR(1)