Conception of a Decisional Tool Using a Pre-Anesthesic Numerical Evaluation (PANE) During the 8th Month of Pregnancy
PANE
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)
1 other identifier
observational
336
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Sep 2020
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedJanuary 10, 2020
November 1, 2019
12 months
December 23, 2019
January 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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
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)
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)
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)
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)
During pre-anesthetic consultation of the 8th month
Study Arms (2)
PANE -> PAC
First, the patient carry out her Pre-Anesthesic Numerical Evaluation and then she benefits from her Pre-Anesthesic Consultation.
PAC -> PANE
First, the patient benefits from her Pre-Anesthesic Consultation and then, she carry out her Pre-Anesthesic Numerical Evaluation
Interventions
Classical Pre-Anesthesic Consultation with an anesthesist of the maternity hospital of Nancy (France)
Home-based Pre-Anesthesic Numerical Evaluation with the aid of a questionnaire, achieved with a computer, digital tablet or smartphone, on a secured platform.
Eligibility Criteria
The study population is the women who benefit from a classical pre-anesthesic consultation in maternity hospital of Nancy.
You may qualify if:
- 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.
You may not qualify if:
- 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
- Language barrier
- Precarious social situation
- Medical pregnancy interruption, foetal death in utero
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Hervé Bouaziz, MD, PhD
Central Hospital, Nancy, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2019
First Posted
January 2, 2020
Study Start
September 1, 2020
Primary Completion
August 31, 2021
Study Completion
February 28, 2022
Last Updated
January 10, 2020
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share