Collection of Information by Tocography External (CIPTEx)

BioSerenity

Status: Completed

Conditions: Pregnancy Related

Treatments: Device: cardiotocograph; Device: Toconaute; Device: electrophysiological device (Micromed)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03444909

2017-A03123-50

Details and patient eligibility

About

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.

Full description

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.

Participating women will receive information from the investigator or the midwife who represents it, and will cover all the points provided for in Article L1122-1. They will be informed of the risks and their right to refuse to participate in a search or to withdraw their consent at any time without incurring any liability or prejudice. Women wishing to participate will receive the newsletter and then sign a consent. A copy of the consent will be issued to them.

As part of the test, the care of the pregnant woman is not changed, the use of the Toconaute will succeed to their usual monitoring with a cardiotocograph. The investigating physician or midwife will therefore follow the recommendations of the usual medical procedure regarding measurements performed by external cardiotocography.

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Multiple pregnancy
• Women requiring a continuous monitoring (in advanced labour)
• Refusal of consent
• Minors
• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

cardiotocograph and Toconaute

Experimental group

Description:

monitoring with cardiotocograph and next with the Toconaute of Bioserenity

Treatment:

Device: cardiotocograph

Device: Toconaute

Cardiotocograph and Toconaute and Electrophysiological device

Experimental group

Description:

monitoring withardiotocograph and next with Toconaute and next with the electrophysiological device

Treatment:

Device: cardiotocograph

Device: electrophysiological device (Micromed)

Device: Toconaute

Cardiotocograph and electrophysiological device

Experimental group

Description:

monitoring with the cardiotocograph and next with the electrophysiological device (Micromed)

Treatment:

Device: cardiotocograph

Device: electrophysiological device (Micromed)