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NCT03690271 Clinical Trial

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

Pregnancy Clinical Trial

— DOPABIEB  

Official title:
Study Programmed Intermittent Epidural Bolus (PIEB) vs PIEB: the Dose is it Variable According to the Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03690271
Other study ID # 35RC17_3083_DOPABIEB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date January 17, 2018

Study information
Verified date September 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date January 17, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Universitaire de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of additional injections during work. two days after infclusion
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