Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fetal heart rate with the TOCONAUTE
研究概览
简要总结
During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions.
The goal here is to assess the performance of the device in real situation during labour.
This study will be carried out in the maternity labor ward in CHU Lille, France.
The TOCONAUTE will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph.
For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman in labor
- •Singleton
- •Cephalic presentation
排除标准
- •Hospitalisation for a medical termination of pregnancy
- •Death in utero
- •Multiple pregnancy
结局指标
主要结局
Fetal heart rate with the TOCONAUTE
时间窗: 1 year
The fetal heart rate from the our device will be averaged on 3 beats and resampled at 4Hz to be comparable to the fetal heart rate from the cardiotocograph. Both of the signals will be resynchronized and compared sample by sample with a Pearson's correlation test. Measure of the fetal heart rate with the TOCONAUTE compared to the measure of the fetal heart rate with a cardiotocograph.
次要结局
- Maternal heart rate with the TOCONAUTE(1 year)
- Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)(1 year)
- Uterine contractions with the TOCONAUTE according to the different phase of labor.(1 year)
- Fetal heart rate with the TOCONAUTE according to the different phase of labor.(1 year)