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

NCT ID: NCT03690271

Last Updated: 2018-10-01

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-01-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia, Epidural Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric WODEY, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Universitaire de Rennes

Rennes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

35RC17_3083_DOPABIEB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Epidural Analgesia During Labour
NCT03133091 COMPLETED PHASE3