NCT03444909

Collection of Information by Tocography External

CIPTEx : Collection of Information by Tocography External

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: BioSerenity · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
DEVICE	cardiotocograph	Monitoring of 20 min with the cardiotocograph
DEVICE	Toconaute	Monitoring of 20 min withToconaute
DEVICE	electrophysiological device (Micromed)	Monitoring of 20 min with the cardiotocograph

Timeline

• Start date: 2018-12-11
• Primary completion: 2019-07-30
• Completion: 2019-12-11
• First posted: 2018-02-26
• Last updated: 2021-11-08

Locations

1 site across 1 country: France