Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2018-12-11
2019-12-11
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
10 women between 24-29 Week of amenorrhea (WA); 15 women between 30-35 WA; 10 women between 36-41 WA will be included.
OTHER
NONE
Study Groups
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cardiotocograph and Toconaute
monitoring with cardiotocograph and next with the Toconaute of Bioserenity
cardiotocograph
Monitoring of 20 min with the cardiotocograph
Toconaute
Monitoring of 20 min withToconaute
Cardiotocograph and Toconaute and Electrophysiological device
monitoring withardiotocograph and next with Toconaute and next with the electrophysiological device
cardiotocograph
Monitoring of 20 min with the cardiotocograph
Toconaute
Monitoring of 20 min withToconaute
electrophysiological device (Micromed)
Monitoring of 20 min with the cardiotocograph
Cardiotocograph and electrophysiological device
monitoring with the cardiotocograph and next with the electrophysiological device (Micromed)
cardiotocograph
Monitoring of 20 min with the cardiotocograph
electrophysiological device (Micromed)
Monitoring of 20 min with the cardiotocograph
Interventions
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cardiotocograph
Monitoring of 20 min with the cardiotocograph
Toconaute
Monitoring of 20 min withToconaute
electrophysiological device (Micromed)
Monitoring of 20 min with the cardiotocograph
Eligibility Criteria
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Inclusion Criteria
* Requiring an intermittent monitoring (including women parturient in pre-labour)
* speaking and understanding well French
* Affiliated to a social security system
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Pitié-Salpêtrière Hospital
OTHER
BioSerenity
INDUSTRY
Responsible Party
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Locations
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Salpêtrière Hospital
Paris, , France
Countries
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Other Identifiers
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2017-A03123-50
Identifier Type: -
Identifier Source: org_study_id