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Activity Modeling in Birth Room

2019年5月24日 更新者:Groupe Hospitalier Paris Saint Joseph

At this time, two methods exist to calculate a pregnant woman's presumed delivery date (DPA) : one adds 280 days to last menstruation date (Naegele rule), other estimates early pregnancy's date by imagery and adds 270 days. Unless pathology requires a trigger, this DPA estimated a early pregnancy is not re-estimated. These methods are simple and arbitrary : Mongelli and al. in 1996 found that out of nearly 40 000 unique pregnancies, only 4% give birth at determined DPA by echography and 70% at more or less 5 days. Jukic and al. in 2013 they estimate a natural variation of 37 days between pregnancy durations. Face of these poor performances, the calculating DPA method seems to be open to improvement.

Thus, the DPA calculation formula does not take into account the individual patients characteristics (age, occupation, antecedents ...), nor the follow-up data collected during pregnancy. Jukic and al. in 2013 propose a first model with some individual characteristics and medical measures (period between ovulation and early pregnancy, hormone peak) to refine the estimation. Their study gives promising results but their small patients number (a hundred) does not allow them to detect all interactions. Moreover, their method calculation is not dynamic, i.e it does not refine the DPA as pregnancy progresses. To our knowledge, no studies developing an evolutionary model over time for the DPA exist. However, objectives of a more accurate estimate of expected date are multiple and important. The investigators will mention here the two main ones :

  • A better understanding of mecanisms leading to early labour or abnormally long gestation in order to anticipate patients at risk
  • A better material and human needs anticipation, allowing a more efficient organization more adapted to activity and a care of each parturient in optimal conditions.

Our study will focus on predictive model elaboration of pregnancy duration that will evolve as the pregnancy progresses and new data collected. The investigators are considering a machine learning methodology by patient's medical record computerization at the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) since early 2016. Thus, for patients who gave birth from end of 2016, the investigators have a large amount of information on their pregnancy and follow-up on hospital servers, which motivates an automatic approach based on massive data analysis.

This study thus intends to implement advanced techniques in Machine Learning (Online Learning, Support Vector Machine ...) to advance a powerful calculation model.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

5100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Paris、法国
        • Groupe Hospitalier Paris Saint Joseph

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Patient who gave birth at GHPSJ maternity between 01/01/2017 and 02/28/2018.

描述

Inclusion Criteria:

  • Patient whose age ≥ 18 years old
  • Patient who gave birth at GHPSJ maternity between 01/01/2017 and 02/28/2018

Exclusion Criteria:

  • Patient who expressed her opposition to participate in the study
  • Patient under guardianship or curatorship (unless consent is provided)
  • Patient who gave birth at less than 32 weeks amenorrhea
  • Pregnancy marked by MFIU (fetal death in utero)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:追溯

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Anticipate deliveries number 48 hours in advance
大体时间:Day 0

Number of anticipate deliveries -H48 Number of deliveries at day 0

So the investigators reported the mean difference between expected and actual delivery date for included patients.

Day 0

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Elie AZRIA, Professor、Groupe Hospitalier Paris Saint Joseph

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年6月22日

初级完成 (实际的)

2018年9月30日

研究完成 (实际的)

2018年12月22日

研究注册日期

首次提交

2019年5月22日

首先提交符合 QC 标准的

2019年5月24日

首次发布 (实际的)

2019年5月28日

研究记录更新

最后更新发布 (实际的)

2019年5月28日

上次提交的符合 QC 标准的更新

2019年5月24日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • MODELSAN

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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