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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Show all 9Show fewer
  • Language barrier
  • Precarious social situation
  • Medical pregnancy interruption, foetal death in utero

Trial locations and contacts

No sites are listed yet.

Hervé Bouaziz, MD, PhD contact

+33 83851403

h.bouaziz@chru-nancy.fr

Martin Eidesheim, M. Sc. contact

+33 659419180

martin.eidesheim@gmail.com

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.

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 groups in NCT04214223
Study groupRoleWhat they receive
PANE -> PACFirst, 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 -> PANEFirst, 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted2 Jan 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion31 Aug 2021 (estimated)
  4. Study completion28 Feb 2022 (estimated)

Resources

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
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

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.

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