CIPTEx : Collection of Information by Tocography External
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioSerenity
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- comparison of measures from Toconaute, cardiotocograph and Micromed device
研究概览
简要总结
The purpose of this trial is to create a comparative database, with data obtained with a new monitoring device of pregnant women,Toconaute, and two standard : a clinical cardiotocograph,and an electrophysiological signal medical device. It will allow to optimize the development of this new device.
The use of the Toconaute and/or the electrophysiological medical device will succeed to the usual monitoring of pregnant women with a cardiotocograph. It will not change their medical care.
The trial will include up to 35 pregnant women between 24 and 41 weeks of amenorrhea that requires discontinuous monitoring. It will last about 12 months, with an estimated inclusion period of 11 month.
详细描述
The main objective is to compare measurements for different gestational age, between: the standard cardiotocograph with those of our device, or between the standard cardiotocograph and the Toconaute and the electrophysiological device, or between the Toconaute and the electrophysiological device.
As a second objective, we want to build a database between the cardiotocograph, the Toconaute and the electrophysiological device, to optimize the development of the Toconaute device.
The trial will include up to 35 healthy adult women pregnant between 24 and 41 weeks of amenorrhea requiring discontinuous monitoring. The trial will not change the usual medical management of women, the Toconaute device will be tested following their usual monitoring. The trial will last approximately 12 months, with an estimated inclusion period of 11 months.
In order to be able to identify possible adverse effects related to the device, women participating simultaneously in another clinical trial can not be included. A delay of 1 month minimum after participation in another clinical trial is requested.
The risks associated with the use of the Toconaute in the trial are considered low and acceptable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pregnant women adult (> 18 years) from 24 to 41 weeks of amenorrhea with or without contractions
- •Requiring an intermittent monitoring (including women parturient in pre-labour)
- •speaking and understanding well French
- •Affiliated to a social security system
排除标准
- •Multiple pregnancy
- •Women requiring a continuous monitoring (in advanced labour)
- •Refusal of consent
- •Wounds on the stomach
- •Women under protection or person not capable of following the procedure of use (according to the judgment of the investigator)
- •Allergy known about the silver, the polyamide, the synthetic materials, a component of STIMEX gel.
- •Use of device on people who the compression of a garment tightened on the stomach could cause pains, respiratory problems or worsening of the health
- •Person equipped with a device of electric stimulation;
- •Current participation in a clinical trial or participation in a previous clinical trial including a period of not past deficiency of 1 month at the time of this clinical trial.
- •Use of the device within for a resuscitation or intensive care
- •person with a defibrillator, a stimulating one of the vagus nerve, or high-frequency surgical device.
结局指标
主要结局
comparison of measures from Toconaute, cardiotocograph and Micromed device
时间窗: 1 year
evaluation of the quality of signal (heart rate of mother and foetus, electrocardiogramme mother and foetus, contractions)
次要结局
- creation of a comparative database between the cardiotocograph and the toconaute and the electrophysiological device (micromed)(1 year)