Surveillance fœtale assistée Par Ordinateur - Obstétrique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ECG Signals Database
研究概览
简要总结
In the context of fetal heart monitoring, the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from few non-invasive sensors on the maternal abdomen, a fetal electrocardiogram (ECGf) of great quality allowing a clinical diagnosis (follow-up of the FHR (fetal heart rate)) and extraction of ECG waveforms).
The proposed approach proposes a technological breakthrough shared by a consortium of researchers and clinicians. The originality is driven by innovative methodological choices: the use of a multimodal system (ECG coupling with PCG (phonocardiographic)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need for the monitoring process support, and by setting up a reference for this multimodal database.
The objective is to feed a database that will be used in the future to develop ECGf extraction methods estimating the FHR.
详细描述
To monitor the well-being of a fetus or for a clinical diagnosis, a challenge is to extract a fetal electrocardiogram (fECG) signal of high quality from a limited number of non-invasive sensors on the maternal abdomen.
During childbirth, fetal monitoring is assessed by the fetal heart rate (FHR), classically from cardiotocography (CTG). The aim is to monitor FHR variability anomalies that reflect a too high fetal malaise. It is very common to have difficulties to reliably record FHR due to confusion of rhythms of the mother and the fetus that can lead to unnecessary caesareans. With 800000 childbirths in France per year, improving the reliability of FHR estimation by fECG analysis is therefore of high clinicalinterest.
To deal with, the proposed approach aims at coupling two complementary cardiac information acquired at the best-located position. Therefore, the proposed solution is (i) to combine the use of electrophysiological sensors ECG and acoustic sensors of microphonic type that can register phonocardiographic signals (PCG), (ii) to assist by computer the clinical expertise to choose the best sensors location. Several methodological aspects will be considered: to improve the robustness of the FHR estimation with degraded signals based on multimodality, to overcome some practical limitations to extract the fECG waveforms by enhancing the process extraction with PCG and to assist the user in the sensors choice and placement by predicting their best locations and their kinds (ECG or PCG).
The SurFAO project proposes then an original approach of computer-assisted fetal monitoring and thus differs from previous published works of fECG extraction solutions, only based on algorithmic performances mostly in well-controlled situations. The original aspects of the investigator's proposal are the innovative methodological choices based on multimodality and informed recording process, the consideration of the medical uses and of the necessity to help the clinical monitoring to design the algorithms, the new reference multimodal database, and the academic-clinical consortium, that will guarantee the relevance of all proposed parts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Pregnant of a single pregnancy,
- •Aged over 18,
- •During the 9th month of pregnancy (>= 37 weeks),
- •With uncomplicated maternal and fetal pregnancy follow-up,
- •With a BMI between 18.5 and 30 at the beginning of pregnancy,
- •Without a notable medical history,
- •Enrolled in a social security scheme,
- •Having signed the consent form for the study.
排除标准
- •Subject under guardianship, protected by law or deprived of liberty (Article L1121-8),
- •Subject under administrative or judicial supervision,
- •Subject in exclusion period of another study,
- •With toxic consumption (i.e. tobacco, alcohol, cannabis),
- •With inaccurate pregnancy term,
- •With denial of pregnancy.
结局指标
主要结局
ECG Signals Database
时间窗: 30 minutes
Synchronized signals from ECG electrodes during a 30-minute monitoring phase. Tracking of the electrical activity in the heart. During the study period we will collect R wave, P wave, QT interval, ST interval, QRS complex, RR interval components of the ECG. Signals were then processed to extract fetal ECG.
PCG Signals Database
时间窗: 30 minutes
Synchronized signals from PCG sensors during a 30-minute monitoring phase. Acquisition of acoustic information reflecting the contraction and relaxation of the heart. During the study period we will collect S1 and S2 sounds components of the PCG. Signals were then processed to extract fetal PCG.
CTG Signals Database
时间窗: 30 minutes
CTG is continuous monitoring of the fetal heart rate (gold standard reference). Physicians evaluate specific clinical CTG parameters by means of visual inspection.
次要结局
- Subject Acceptability: Score(15 minutes)
- Subject Acceptability : Descriptive analysis(15 minutes)
- Use Error evaluation : System Usability Scale (SUS)(15 minutes)
- Use Error evaluation : Descriptive analysis(15 minutes)