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

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ClinicalTrials.gov Identifier: NCT02853890
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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

Condition or disease Intervention/treatment
Birth Other: Questionnaires during hospitalization for delivery

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Study Type : Observational
Estimated Enrollment : 2500 participants
Time Perspective: Prospective
Official Title: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)
Study Start Date : February 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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

  2. 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


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All woman patients hospitalized for delivery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853890


Contacts
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Contact: Dominique Chassard, Pr 4 72 12 97 63 ext +33 dominique.chassard@chu-lyon.fr
Contact: Delphine Bernoux, MD 4 72 31 72 35 ext +33 Delphine.bernoux@chu-lyon.fr

Locations
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France
Hôpital Femme Mère Enfant Recruiting
Lyon, France
Contact: Dominique Chassard       dominique.chassard@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Dominique Chassard, Pr Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02853890    
Other Study ID Numbers: 69HCL15_0047
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Birth
obstetric analgesia
obstetric anesthesia