Epidural AnalgesiaAOMHENCT03314571
Obstetrical Analgesia in the Estaing Hospital Maternity. A Prospective Database to Study the Determinants of Labor Pain and the Resulting Maternal Non Satisfaction.
An observational study of Epidural Analgesia and Hospital Follow-up, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
There is a trend to offer personalized care in many medical domains. In the field of labor pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain is only one of its determinants, competing with psychological and sociological factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Analgesia, Hospital Follow-up
- What is being tested?
- analgesia for labor
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2017to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women
Who may be able to join
- Any parturient coming for her regular pre-partum anesthesia visit at the Estaing Hospital Maternity
Who cannot join
- Refusal of epidural analgesia at the time of the visit.
- Participation refusal.
- Inability to answer the pre- or post-partum questionnaires.
- Any medical condition considered as a relevant exclusion criterion by the investigator.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Brigitte STORME
About this study
There is a trend to offer personalized care in many medical domains. In the field of labor pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain is only one of its determinants, competing with psychological and sociological factors. Furthermore, labor pain is also multifactorial, depending on predisposition to pain, the way analgesia is conducted, and other environmental factors. We wish to develop predicting models of maternal satisfaction, in order to offer in the future a better tailored analgesia.
Read the detailed description
The observation shall be conducted at 3 major points of measurement throughout labor:
- Pre-, i.e. at the systematic visit for anesthesia, during the 3rd trimester of pregnancy. The collected variables will be: demographic, morphometric, socioeconomic, psychometric. The latter shall consist in a short questionnaire-based assessment by: Hospital Anxiety and Depression Scale, 5-points Mental Health Inventory, Life Orientation Scale. As soon as it will be validated, a Pain Sensitivity Questionnaire shall be added.
- Intra-, i.e. clinical data from the anesthesia file: conduction of epidural analgesia, labor pain, drug consumption, obstetrical outcomes.
- Post-, i.e. maternal satisfaction assessed by a set of seven 11-point numerical rating scales at day2 post childbirth, along with a written short qualitative assessment.
Different multivariable statistical models shall be used to identify the patients profiles and the possible determinants of satisfaction: descriptive (factorial analyses) and inferential (GLM or longitudinal).
- Conditions
- Epidural Analgesia, Hospital Follow-up
- Being tested
- analgesia for labor
- Keywords
- Epidural analgesia, Labor pain, Satisfaction, Care assessment, Psychometry
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesia for laborOther
A prospective database to study the determinants of labor pain and the resulting maternal non satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| non applicable | Not described Receives: Other: analgesia for labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal satisfaction about analgesia for labor
Eight-domain questionnaire designed for the purpose of the study, each domain being addressed by an 11-point numerical scale from 0 (not satisfied at all) to 10 (totally satisfied). The 8 domains are: general analgesia care, rapidity of analgesia, pain control at expulsion, mobility during labor, self-control of labor, caregivers' attention, pain at epidural puncture, information about epidural.
Measured: from the morning of day 2 postpartum to the morning of day 3 postpartum.
Secondary outcomes (2)
Wish for a similar analgesia for future labor.
Measured: from the morning of day 2 postpartum to the morning of day 3 postpartum.
Qualitative maternal concerns about analgesia for labor
verbatim (free field).
Measured: from the morning of day 2 postpartum to the morning of day 3 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study startNov 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte STORME, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314571
- Sponsor's protocol ID
- CHU-357
- Other IDs
- 2017-A00814-49
- Acronym
- AOMHE
- Status last verified
- Nov 2017
- First submitted
- 16 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical Analgesia in the Estaing Hospital Maternity. A Prospective Database to Study the Determinants of Labor Pain and the Resulting Maternal Non Satisfaction.
- ClinicalTrials.gov ID
- NCT03314571
- Acronym / sponsor ID
- AOMHE / CHU-357
- Conditions
- Epidural Analgesia, Hospital Follow-up
- Keywords
- Epidural analgesia, Labor pain, Satisfaction, Care assessment, Psychometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Oct 2017 (actual)
- 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.
There is a trend to offer personalized care in many medical domains. In the field of labor pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain is only one of its determinants, competing with psychological and sociological factors. Furthermore, labor pain is also multifactorial, depending on predisposition to pain, the way analgesia is conducted, and other environmental factors. We wish to develop predicting models of maternal satisfaction, in order to offer in the future a better tailored analgesia.
Detailed description
The observation shall be conducted at 3 major points of measurement throughout labor:
- Pre-, i.e. at the systematic visit for anesthesia, during the 3rd trimester of pregnancy. The collected variables will be: demographic, morphometric, socioeconomic, psychometric. The latter shall consist in a short questionnaire-based assessment by: Hospital Anxiety and Depression Scale, 5-points Mental Health Inventory, Life Orientation Scale. As soon as it will be validated, a Pain Sensitivity Questionnaire shall be added.
- Intra-, i.e. clinical data from the anesthesia file: conduction of epidural analgesia, labor pain, drug consumption, obstetrical outcomes.
- Post-, i.e. maternal satisfaction assessed by a set of seven 11-point numerical rating scales at day2 post childbirth, along with a written short qualitative assessment.
Different multivariable statistical models shall be used to identify the patients profiles and the possible determinants of satisfaction: descriptive (factorial analyses) and inferential (GLM or longitudinal).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non applicable | – | Other: analgesia for labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women
Key inclusion criteria (1 listed)
- Any parturient coming for her regular pre-partum anesthesia visit at the Estaing Hospital Maternity
Key exclusion criteria (4 listed)
- Refusal of epidural analgesia at the time of the visit.
- Participation refusal.
- Inability to answer the pre- or post-partum questionnaires.
- Any medical condition considered as a relevant exclusion criterion by the investigator.
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 |
|---|---|---|
| analgesia for laborA prospective database to study the determinants of labor pain and the resulting maternal non satisfaction. | Other | non applicable |
Primary outcome
Maternal satisfaction about analgesia for labor
Time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum.
Eight-domain questionnaire designed for the purpose of the study, each domain being addressed by an 11-point numerical scale from 0 (not satisfied at all) to 10 (totally satisfied). The 8 domains are: general analgesia care, rapidity of analgesia, pain control at expulsion, mobility during labor, self-control of labor, caregivers' attention, pain at epidural puncture, information about epidural.
2 secondary outcomes
Wish for a similar analgesia for future labor.
Time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum.
Qualitative maternal concerns about analgesia for labor
Time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
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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.
Brigitte STORME principal investigator
University Hospital, Clermont-Ferrand
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 Epidural Analgesia and Hospital Follow-up, run by University Hospital, Clermont-Ferrand 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 4 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 9 Nov 2017. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal satisfaction about analgesia for labor (time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2017.