Collection of Information by Tocography External

NCT03444909 | Completed

• 1 other identifier: 2017-A03123-50
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Monitoring

Outcome Measures

Primary Outcomes (1)

• comparison of measures from Toconaute, cardiotocograph and Micromed device

  evaluation of the quality of signal (heart rate of mother and foetus, electrocardiogramme mother and foetus, contractions)

  1 year

Secondary Outcomes (1)

• creation of a comparative database between the cardiotocograph and the toconaute and the electrophysiological device (micromed)

  1 year

Study Arms (3)

cardiotocograph and Toconaute

EXPERIMENTAL

monitoring with cardiotocograph and next with the Toconaute of Bioserenity

Device: cardiotocograph; Device: Toconaute

Cardiotocograph and Toconaute and Electrophysiological device

EXPERIMENTAL

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

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

Cardiotocograph and electrophysiological device

EXPERIMENTAL

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

Device: cardiotocograph; Device: electrophysiological device (Micromed)

Interventions

cardiotocograph DEVICE

Monitoring of 20 min with the cardiotocograph

Cardiotocograph and Toconaute and Electrophysiological device; Cardiotocograph and electrophysiological device; cardiotocograph and Toconaute

Toconaute DEVICE

Monitoring of 20 min withToconaute

Cardiotocograph and Toconaute and Electrophysiological device; cardiotocograph and Toconaute

electrophysiological device (Micromed) DEVICE

Monitoring of 20 min with the cardiotocograph

Cardiotocograph and Toconaute and Electrophysiological device; Cardiotocograph and electrophysiological device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioSerenity: lead
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

Salpêtrière Hospital

Paris, 75013, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: February 26, 2018
• Study Start: December 11, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 11, 2019
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

FR (1)