Management of Obstetrical Pain: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (Epidol)

July 29, 2016 updated by: Hospices Civils de Lyon

" 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)

Obstetric analgesia is a requirement of our times. The different applicable methods vary in effectiveness. The essential part is represented by epidural analgesia which remains one of the most effective methods. It is important to know other methods to respond to all requests. The applications of these methods, patient satisfaction and psychic experience, complications or incidents remain poorly or partially evaluated in France.

The main objective is to describe the different techniques of anesthesia/analgesia actually used in France for the management of pain during vaginal deliveries and cesarean sections on a representative sample of all maternity hospitals at a given time(7 days per maternity hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).

Secondary objectives will be multiple :

  • Describe the results of analgesic methods on the physical pain of patients during labor by a global visual analog scale
  • Describe the feeling of pregnant women relative to the different anesthesic and analgesic techniques, by an analysis of the questionnaire responses
  • Describe the frequency of adverse events of birth

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Recruiting
        • Hopital Femme Mere Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All woman patients hospitalized for delivery

Description

Inclusion Criteria:

  • All patients hospitalized in a maternity hospital for delivery during the 7 days defined for the study will be included

Exclusion Criteria:

  • Patients under 18 years old
  • Lack of understanding of the French language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant woman
Other: Questionnaires during hospitalization for delivery
Questionnaires during hospitalization for delivery (one questionnaire completed by doctors about different technic of analgesia and anesthesia and one questionnaire completed by women about pain, and feeling about the different techniques of analgesia and anesthesia used during delivery, eventually caesarean section or uterine revision)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of analgesia techniques
Time Frame: Day 0
description of the different techniques of analgesia during labor, uterine revision and eventually cesarean section assessed by a questionnaire
Day 0
Type of anesthesia techniques
Time Frame: Day 0
description of the different techniques of anesthesia during labor, uterine revision and eventually cesarean section assessed by a questionnaire
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
physical pain assessed by using a visual analog scale.
Time Frame: Day 1
Day 1
Assessment of the feeling of pregnant women about the analgesic and anesthesic techniques by a questionnaire
Time Frame: Day 2
Day 2
Collect of adverse events
Time Frame: Day 2
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Dominique Chassard, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL15_0047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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