BirthEpidolNCT02853890
Management of Obstetrical Pain: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France"
An observational study of Birth, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth
- What is being tested?
- Questionnaires during hospitalization for delivery
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All woman patients hospitalized for delivery
Who may be able to join
- All patients hospitalized in a maternity hospital for delivery during the 7 days defined for the study will be included
Who cannot join
- Patients under 18 years old
- Lack of understanding of the French language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme Mère Enfant
Lyon
Dominique Chassard, dominique.chassard@chu-lyon.fr
About this study
Official title: " 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).
Read more
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
- Conditions
- Birth
- Being tested
- Questionnaires during hospitalization for delivery
- Keywords
- Birth, obstetric analgesia, obstetric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| pregnant woman | Not described Receives: Other: Questionnaires during hospitalization for delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of analgesia techniques
description of the different techniques of analgesia during labor, uterine revision and eventually cesarean section assessed by a questionnaire
Measured: 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
Measured: Day 0
Secondary outcomes (3)
physical pain assessed by using a visual analog scale.
Measured: Day 1
Assessment of the feeling of pregnant women about the analgesic and anesthesic techniques by a questionnaire
Measured: Day 2
Collect of adverse events
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BirthStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Chassard, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853890
- Sponsor's protocol ID
- 69HCL15_0047
- Acronym
- Epidol
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37709198
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)
- ClinicalTrials.gov ID
- NCT02853890
- Acronym / sponsor ID
- Epidol / 69HCL15_0047
- Conditions
- Birth
- Keywords
- Birth, obstetric analgesia, obstetric anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant woman | – | Other: Questionnaires during hospitalization for delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All woman patients hospitalized for delivery
Key inclusion criteria (1 listed)
- All patients hospitalized in a maternity hospital for delivery during the 7 days defined for the study will be included
Key exclusion criteria (2 listed)
- Patients under 18 years old
- Lack of understanding of the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires during hospitalization for deliveryQuestionnaires 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) | Other | pregnant woman |
Primary outcome
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
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
3 secondary outcomes
physical pain assessed by using a visual analog scale.
Time frame: Day 1
Assessment of the feeling of pregnant women about the analgesic and anesthesic techniques by a questionnaire
Time frame: Day 2
Collect of adverse events
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Derived from this study: PubMed 37709198Chassard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Chassard, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Chassard, Pr (4 72 12 97 63 ext. +33, dominique.chassard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of analgesia techniques (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02853890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.