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

Birth Clinical Trial

— Epidol  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853890
• Other study ID #: 69HCL15_0047
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: July 29, 2016
• Start date: February 2016
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: Dominique Chassard, Pr
• Phone: 4 72 12 97 63
• Email: dominique.chassard[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth

Intervention

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)

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of analgesia techniques	description of the different techniques of analgesia during labor, uterine revision and eventually cesarean section assessed by a questionnaire	Day 0	No
Primary	Type of anesthesia techniques	description of the different techniques of anesthesia during labor, uterine revision and eventually cesarean section assessed by a questionnaire	Day 0	No
Secondary	physical pain assessed by using a visual analog scale.		Day 1	No
Secondary	Assessment of the feeling of pregnant women about the analgesic and anesthesic techniques by a questionnaire		Day 2	No
Secondary	Collect of adverse events		Day 2	Yes