Computer-assisted Fetal Monitoring - Cardiology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ultrasound signals database
研究概览
简要总结
In the context of fetal heart monitoring (prenatal and during childbirth), the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from 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 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 (phonocardiography)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need to support the monitoring process, and by setting up a multimodal database.
The objective is to feed a database that will be used in the future to develop ECGf extraction methods.
详细描述
To monitor the well-being of a fetus or for clinical diagnosis, the challenge is to extract a high-quality fetal electrocardiogram (fECG) signal from non-invasive sensors on the maternal abdomen.
As early as the 20th week of amenorrhea, heart rhythm disorders (tachycardia, bradycardia) can be detected in the fetus, most often by fortuitous circumstance, during routine obstetrical ultrasound examinations. It is then necessary to analyze these rhythmic anomalies, understand their origin and, if necessary, initiate pharmacotherapy. The effectiveness of the treatments is then monitored by ultrasound in the high-risk pregnancy department.
The analysis of a fetal electrocardiogram (fECG) provides information that allows to determine the nature of the rhythm disorder, its origin and therefore its potential severity.
The innovative methodological approach considered for the extraction of non-invasive ECGf is to combine 2 complementary modalities of the same cardiac phenomenon. This is achieved by combining the use of ECG sensors with sound sensors giving access to phonocardiographic signals (PCG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •single pregnancy
- •between 20 and 26 weeks of amenorrhea
- •with a BMI between 18.5 and 30 at the beginning of pregnancy
- •fetal heart considered normal after expert ultrasound
- •examination conditions deemed correct by the expert
- •registered in a social security scheme
- •having signed the study consent form
排除标准
- •subject to a legal protection measure or unable to express consent (guardianship, guardianship) (article L1121-8)
- •deprived of liberty by judicial or administrative decision (article L1121-6)
- •in a period of exclusion from another study
- •with toxic consumption (i.e. tobacco, alcohol, cannabis)
- •Intrauterine growth retardation (estimated fetal weight less than the 10th percentile)
- •fetal heart rhythm disorders
- •with unclear pregnancy term
- •with pregnancy denial
结局指标
主要结局
Ultrasound signals database
时间窗: 10 minutes
The fetal heart activity is analyzed using mechanograms and Doppler during ultrasound (gold standard).
ECG / PCG Signals database
时间窗: 20 minutes
Synchronized signals from ECG electrodes and PCG sensors. Signals will be processed to extract fetal ECG and specific waveforms characteristics of fECG (in parts of R waves, P waves, QT intervals, ST intervals).
次要结局
- Use Error evaluation : System Usability Scale (SUS)(10 minutes)
- Use Error evaluation : Descriptive analysis(60 minutes)
- Subject Acceptability : Descriptive analysis(10 minutes)
- Subject acceptability : Score(10 minutes)