Clinical trial NCT03444909: Collection of Information by Tocography External
Official title: CIPTEx : Collection of Information by Tocography External
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Monitoring
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
Collaborators: name: Pitié-Salpêtrière Hospital
First posted: 2018-02-26
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 35 women will be divided into 3 test groups. results will be analyse in fonction of the repartition of the gestationnal age

10 women between 24-29 Week of amenorrhea (WA); 15 women between 30-35 WA; 10 women between 36-41 WA will be included.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: comparison of measures from Toconaute, cardiotocograph and Micromed device
timeFrame: 1 year
Secondary outcomes:
measure: creation of a comparative database between the cardiotocograph and the toconaute and the electrophysiological device (micromed)
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Salpêtrière Hospital
Study officials:
References: