Status:
COMPLETED
Collection of Information by Tocography External
Lead Sponsor:
BioSerenity
Collaborating Sponsors:
Pitié-Salpêtrière Hospital
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
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 electro...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03444909
Start Date
December 11 2018
End Date
December 11 2019
Last Update
November 8 2021
Active Locations (1)
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1
Salpêtrière Hospital
Paris, France, 75013