NCT02853890

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 29, 2016

Last Update Submit

July 29, 2016

Conditions

Birth

Keywords

Birthobstetric analgesiaobstetric anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • physical pain assessed by using a visual analog scale.

    Day 1

  • Assessment of the feeling of pregnant women about the analgesic and anesthesic techniques by a questionnaire

    Day 2

  • Collect of adverse events

    Day 2

Study Arms (1)

pregnant woman

Other: Questionnaires during hospitalization for delivery

Interventions

Questionnaires during hospitalization for deliveryOTHER

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)

pregnant woman

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All woman patients hospitalized for delivery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère Enfant

Lyon, France

RECRUITING

Related Publications (1)

  • Chassard D, Langlois-Jacques C, Naaim M, Galetti S, Bouvet L, Coz E, Ecochard R, Portefaix A, Kassai-Koupai B; CARO Group. Anesthesia practices for management of labor pain and cesarean delivery in France (EPIDOL): A cross-sectional survey. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101302. doi: 10.1016/j.accpm.2023.101302. Epub 2023 Sep 12.

    PMID: 37709198DERIVED

MeSH Terms

Interventions

Parturition

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Dominique Chassard, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Chassard, Pr

CONTACT

4 72 12 97 63dominique.chassard@chu-lyon.fr

Delphine Bernoux, MD

CONTACT

4 72 31 72 35Delphine.bernoux@chu-lyon.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 3, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 3, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)