Last updated on January 2019

Patients are needed to participate in a clinical research study to evaluate Pregnancy Related

Brief description of study

The purpose of this trial is to create a comparative database, with data obtained with a new monitoring device of pregnant women,Toconaute, and a standard clinical cardiotocograph, It will allow to optimize the development of this new device.

The use of the Toconaute 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.

Detailed Study Description

The purpose of the CIPTEx study is to create a comparative database between the Toconaute and a standard clinical cardiotocograph.

The main objective is to compare measurements from a standard cardiotocograph with those of our device for different gestational ages.

From these measurements and clinical data, we want to build, as a second objective, a database 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.

Clinical Study Identifier: NCT03444909

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Recruitment Status: Open

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