Pregnancy RelatedPANENCT04214223
Conception of a Decisional Tool Using a Pre-Anesthesic Numerical Evaluation (PANE) During the 8th Month of Pregnancy
An observational study of Pregnancy Related, run by Central Hospital, Nancy, France.
Trial summary
In France, all pregnant women benefit from an pre-anesthesic consultation (PAC) to evaluate their physical and biological conditions. Many of pregnant women are healthy, there is only on type of induction protocol in case of general anesthesia, they are all at risk of difficult intubation and blood samples are already… 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
- Pregnancy Related
- What is being tested?
- Pre-Anesthesic Consultation and Pre-Anesthesic Numerical Evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 28 Feb 2022
- How long will I take part?
- 1 Month
- 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: The study population is the women who benefit from a classical pre-anesthesic consultation in maternity hospital of Nancy.
Who may be able to join
- Major women profiting of a planned pre-anesthesic consultation
- Women who received complete information on research management and who didn't refuse to her participation and her data use.
Who cannot join
- Participation refusal
- Women without liberty because of a legal or administrative decision
- Women who benefit of psychiatric cares
- Underage women
- Women with legal protection (ex : guardianship)
- Women who can't express their consent
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- Language barrier
- Precarious social situation
- Medical pregnancy interruption, foetal death in utero
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of a New Tool for a Numeric Pre-anesthesic Evaluation for Pregnant Women During Their Pregnancy Follow-up in University and Regional Maternity of Nancy (France)
In France, all pregnant women benefit from an pre-anesthesic consultation (PAC) to evaluate their physical and biological conditions.
Many of pregnant women are healthy, there is only on type of induction protocol in case of general anesthesia, they are all at risk of difficult intubation and blood samples are already performed by obstetricians.
Read more
Thus, investigators' hypothesis is that for many pregnant women, an alternative pre-anesthesic evaluation, other than the classic 8th month PAC is possible. So, the investigators would create a tool able to perform a women's triage, and to detect which of them have to see an anesthesist during a face-to-face consultation and which of them could do without it.
Investigators' study will be about the monocentric analysis of a pre-anesthesic numerical evaluation with the aid of a questionnaire, vouched for by an experts committee specialized in obstetrical anesthesia.
Read the detailed description
Every month, several thousands of women benefit from an obstetrical pre-anesthesic consultation (PAC) in France, during their 8th month of pregnancy. It is the opportunity to evaluate women's physical and biological conditions before their delivery.
This consultation is mandatory in France. It must be carried out by an anesthesist and should aim at proposing an analgesic and anesthesic strategies as well as relaying all the resulting information to the patients.
A study carried out in 2015 in two Parisian 3rd level maternity hospitals showed that the majority of women seen in obstetrical PAC are healthy. A preliminary observational, prospective and multicentric study in 20 Lorraine (France) maternity hospitals was implemented in order to identify more specifically the population of women seen during this consultation. Despite of a probable under-estimation, investigators' results showed 40,3% of women ASA 1, with a physiologic pregnancy, without hemostasis disorder and planned for a vaginal delivery.
With these healthy women, according to the recommendations of the French Society of Anesthesia and Intensive Care (SFAR) edited in 2012 and those of the French Health Authority (HAS) edited in 2016, the only obligatory biological exam for the anesthesic care is the 6th month blood count (with blood type and irregular antibodies).
Despite those recommendations, over-prescription of biological tests during the preoperative clinic in pre-partum persists (in the investigators' study, they found a probable under-estimated number of 34,5% unjustified prescriptions).
Moreover, the PAC aims at evaluating superior airways, for the purpose of a potential oro-tracheal cannulation in case of general anesthesia. However, this evaluation had a relative interest in this context considering that the superior airways anatomy changes during pregnancy and labor and all pregnant women must all be considered at risk of difficult intubation.
In addition, all pregnant women from 20 weeks of amenorrhea are considered as full stomach. Thus, in case of general anesthesia, the investigators have to perform a crash induction. So, there is no other protocol of induction to consider in this context.
Regardless of the context, pregnant women see an anesthesist before their delivery during the pre-anesthesic visit : the sooner 24 hours before an intervention, at the latest when they arrive in the delivery room.
Actually, society is faced with important problems of medical demography and anesthesists are less and less numerous, making their activity more and more difficult.
Investigators' hypothesis is that for the population of pregnant healthy women, an alternative pre-anesthesic evaluation, other than the classic 8th month PAC, could be an innovative idea for health system, ensuring care quality and security of pregnant women.
The investigators would create a new tool able to perform a women's triage, and to detect which of them have to see an anesthesist during a face-to-face consultation and which of them could do without it.
Those types of pre-anesthesic evaluations have already been tested in other countries. A controlled randomized study, executed in Australia between 2012 and 2013, showed the feasibility of a non "in-person" evaluation (by phone, with the aid of an informatic tool and a anesthesist proofreading). Considering these results, the investigators think that it is possible to transpose this type of evaluation to the obstetrical field.
Investigators' study will be about the monocentric analysis of a pre-anesthesic numerical evaluation with the aid of a questionnaire, vouched for by an experts committee specialized in obstetrical anesthesia.
Ultimately, investigators' ambition is to carry out a national multicentric study to analyze this tool on a larger scale.
- Conditions
- Pregnancy Related
- Being tested
- Pre-Anesthesic Consultation, Pre-Anesthesic Numerical Evaluation
- Keywords
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Anesthesic ConsultationOther
Classical Pre-Anesthesic Consultation with an anesthesist of the maternity hospital of Nancy (France)
Pre-Anesthesic Numerical EvaluationOther
Home-based Pre-Anesthesic Numerical Evaluation with the aid of a questionnaire, achieved with a computer, digital tablet or smartphone, on a secured platform.
| Study group | Role | What they receive |
|---|---|---|
| PANE -> PAC | First, the patient carry out her Pre-Anesthesic Numerical Evaluation and then she benefits from her Pre-Anesthesic Consultation. Receives: Other: Pre-Anesthesic Consultation; Other: Pre-Anesthesic Numerical Evaluation | |
| PAC -> PANE | First, the patient benefits from her Pre-Anesthesic Consultation and then, she carry out her Pre-Anesthesic Numerical Evaluation Receives: Other: Pre-Anesthesic Consultation; Other: Pre-Anesthesic Numerical Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated Pre-Anesthesic Numerical Evaluation questionnaire
Conception of a new and numerical tool for the obstetrical pre-anesthesic evaluation of pregnant women during their pregnancy follow-up. This conception will contain, first, the creation of the questionnaire and then the assessment of the questionnaire's effectiveness in a monocentric study.
Measured: Before enrollment of first pregnant women and during pre-anesthetic consultation of the 8th month.
Secondary outcomes (5)
Elaborate and validate the first version of Pre-Anesthesic Numerical Evaluation questionnaire
Using the French Health Authority's method published in 2010 : " Recommendations by formalized consensus", validation of the questionnaire with the aid of an experts committee specialized in obstetrical anesthesia.
Measured: Before enrollment of first pregnant women
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including birth mode : vaginal delivery or caesarean.
Measured: During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including American Society of Anesthesiologists (ASA) score : 1 (better outcome), 2, 3, 4 or 5.
Measured: During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including existence of bleeding diathesis : Yes or No.
Measured: During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Compare the 8th month pre-anesthesic evaluation realized during the classical pre-anesthesic consultation in comparison with the new tool of pre-anesthesic numerical evaluation. The comparison will be proceed thanks to a composite endpoint including existence of non-physiologic pregnancy : physiologic pregnancy or non-physiologic pregnancy.
Measured: During pre-anesthetic consultation of the 8th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 336 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé Bouaziz, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214223
- Sponsor's protocol ID
- 2019PI140
- Acronym
- PANE
- Status last verified
- Nov 2019
- First submitted
- 23 Dec 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Tool for a Numeric Pre-anesthesic Evaluation for Pregnant Women During Their Pregnancy Follow-up in University and Regional Maternity of Nancy (France)
- ClinicalTrials.gov ID
- NCT04214223
- Acronym / sponsor ID
- PANE / 2019PI140
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 2 Jan 2020 (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.
In France, all pregnant women benefit from an pre-anesthesic consultation (PAC) to evaluate their physical and biological conditions.
Many of pregnant women are healthy, there is only on type of induction protocol in case of general anesthesia, they are all at risk of difficult intubation and blood samples are already performed by obstetricians.
Thus, investigators' hypothesis is that for many pregnant women, an alternative pre-anesthesic evaluation, other than the classic 8th month PAC is possible. So, the investigators would create a tool able to perform a women's triage, and to detect which of them have to see an anesthesist during a face-to-face consultation and which of them could do without it.
Investigators' study will be about the monocentric analysis of a pre-anesthesic numerical evaluation with the aid of a questionnaire, vouched for by an experts committee specialized in obstetrical anesthesia.
Detailed description
Every month, several thousands of women benefit from an obstetrical pre-anesthesic consultation (PAC) in France, during their 8th month of pregnancy. It is the opportunity to evaluate women's physical and biological conditions before their delivery.
This consultation is mandatory in France. It must be carried out by an anesthesist and should aim at proposing an analgesic and anesthesic strategies as well as relaying all the resulting information to the patients.
A study carried out in 2015 in two Parisian 3rd level maternity hospitals showed that the majority of women seen in obstetrical PAC are healthy. A preliminary observational, prospective and multicentric study in 20 Lorraine (France) maternity hospitals was implemented in order to identify more specifically the population of women seen during this consultation. Despite of a probable under-estimation, investigators' results showed 40,3% of women ASA 1, with a physiologic pregnancy, without hemostasis disorder and planned for a vaginal delivery.
With these healthy women, according to the recommendations of the French Society of Anesthesia and Intensive Care (SFAR) edited in 2012 and those of the French Health Authority (HAS) edited in 2016, the only obligatory biological exam for the anesthesic care is the 6th month blood count (with blood type and irregular antibodies).
Despite those recommendations, over-prescription of biological tests during the preoperative clinic in pre-partum persists (in the investigators' study, they found a probable under-estimated number of 34,5% unjustified prescriptions).
Moreover, the PAC aims at evaluating superior airways, for the purpose of a potential oro-tracheal cannulation in case of general anesthesia. However, this evaluation had a relative interest in this context considering that the superior airways anatomy changes during pregnancy and labor and all pregnant women must all be considered at risk of difficult intubation.
In addition, all pregnant women from 20 weeks of amenorrhea are considered as full stomach. Thus, in case of general anesthesia, the investigators have to perform a crash induction. So, there is no other protocol of induction to consider in this context.
Regardless of the context, pregnant women see an anesthesist before their delivery during the pre-anesthesic visit : the sooner 24 hours before an intervention, at the latest when they arrive in the delivery room.
Actually, society is faced with important problems of medical demography and anesthesists are less and less numerous, making their activity more and more difficult.
Investigators' hypothesis is that for the population of pregnant healthy women, an alternative pre-anesthesic evaluation, other than the classic 8th month PAC, could be an innovative idea for health system, ensuring care quality and security of pregnant women.
The investigators would create a new tool able to perform a women's triage, and to detect which of them have to see an anesthesist during a face-to-face consultation and which of them could do without it.
Those types of pre-anesthesic evaluations have already been tested in other countries. A controlled randomized study, executed in Australia between 2012 and 2013, showed the feasibility of a non "in-person" evaluation (by phone, with the aid of an informatic tool and a anesthesist proofreading). Considering these results, the investigators think that it is possible to transpose this type of evaluation to the obstetrical field.
Investigators' study will be about the monocentric analysis of a pre-anesthesic numerical evaluation with the aid of a questionnaire, vouched for by an experts committee specialized in obstetrical anesthesia.
Ultimately, investigators' ambition is to carry out a national multicentric study to analyze this tool on a larger scale.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PANE -> PAC | – | Other: Pre-Anesthesic Consultation, Other: Pre-Anesthesic Numerical EvaluationFirst, the patient carry out her Pre-Anesthesic Numerical Evaluation and then she benefits from her Pre-Anesthesic Consultation. |
| PAC -> PANE | – | Other: Pre-Anesthesic Consultation, Other: Pre-Anesthesic Numerical EvaluationFirst, the patient benefits from her Pre-Anesthesic Consultation and then, she carry out her Pre-Anesthesic Numerical Evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is the women who benefit from a classical pre-anesthesic consultation in maternity hospital of Nancy.
Key inclusion criteria (2 listed)
- Major women profiting of a planned pre-anesthesic consultation
- Women who received complete information on research management and who didn't refuse to her participation and her data use.
Key exclusion criteria (9 listed)
- Participation refusal
- Women without liberty because of a legal or administrative decision
- Women who benefit of psychiatric cares
- Underage women
- Women with legal protection (ex : guardianship)
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 |
|---|---|---|
| Pre-Anesthesic ConsultationClassical Pre-Anesthesic Consultation with an anesthesist of the maternity hospital of Nancy (France) | Other | PAC -> PANE, PANE -> PAC |
| Pre-Anesthesic Numerical EvaluationHome-based Pre-Anesthesic Numerical Evaluation with the aid of a questionnaire, achieved with a computer, digital tablet or smartphone, on a secured platform. | Other | PAC -> PANE, PANE -> PAC |
Primary outcome
Validated Pre-Anesthesic Numerical Evaluation questionnaire
Time frame: Before enrollment of first pregnant women and during pre-anesthetic consultation of the 8th month.
Conception of a new and numerical tool for the obstetrical pre-anesthesic evaluation of pregnant women during their pregnancy follow-up. This conception will contain, first, the creation of the questionnaire and then the assessment of the questionnaire's effectiveness in a monocentric study.
5 secondary outcomes
Elaborate and validate the first version of Pre-Anesthesic Numerical Evaluation questionnaire
Time frame: Before enrollment of first pregnant women
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Time frame: During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Time frame: During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Time frame: During pre-anesthetic consultation of the 8th month
Validate the first version of Pre-Anesthesia Numerical Evaluation within the population of pregnant women of Maternity Hospital of Nancy (France)
Time frame: During pre-anesthetic consultation of the 8th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- 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.
Hervé Bouaziz, MD, PhD principal investigator
Central Hospital, Nancy, France
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Central Hospital, Nancy, 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 2 inclusion and 9 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Hervé Bouaziz, MD, PhD (+33 83851403, h.bouaziz@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated Pre-Anesthesic Numerical Evaluation questionnaire (time frame: Before enrollment of first pregnant women and during pre-anesthetic consultation of the 8th month.). 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 10 Jan 2020.