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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 336
- 主要终点
- Validated Pre-Anesthesic Numerical Evaluation questionnaire
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Validated Pre-Anesthesic Numerical Evaluation questionnaire
时间窗: 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.
次要结局
- 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)