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NCT03444909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-11-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Pitié-Salpêtrière Hospital

    collaborator OTHER

  • BioSerenity

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-07-30
Completion
2019-12-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444909 on ClinicalTrials.gov