Pregnancy Related Clinical Trial
— CIPTExOfficial title:
CIPTEx : Collection of Information by Tocography External
Verified date | November 2021 |
Source | BioSerenity |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 11, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Salpêtrière Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
BioSerenity | Pitié-Salpêtrière Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | creation of a comparative database between the cardiotocograph and the toconaute and the electrophysiological device (micromed) | databases will be created comparing data from cardiotocograph and data from toconaute and data from the electrophysiological device | 1 year |
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