Pregnancy RelatedCIPTExNCT03444909
Collection of Information by Tocography External
A study testing cardiotocograph, Toconaute and electrophysiological device (Micromed) in people with Pregnancy Related, run by BioSerenity at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- cardiotocograph, Toconaute and electrophysiological device (Micromed)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2018to 11 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CIPTEx : Collection of Information by Tocography External
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.
Read the 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
- Being tested
- cardiotocograph, Toconaute, electrophysiological device (Micromed)
- Keywords
- Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiotocographDevice
Monitoring of 20 min with the cardiotocograph
ToconauteDevice
Monitoring of 20 min withToconaute
electrophysiological device (Micromed)Device
Monitoring of 20 min with the cardiotocograph
| Study group | Role | What they receive |
|---|---|---|
| cardiotocograph and Toconaute | Experimental | monitoring with cardiotocograph and next with the Toconaute of Bioserenity Receives: Device: cardiotocograph; Device: Toconaute |
| Cardiotocograph and Toconaute and Electrophysiological device | Experimental | monitoring withardiotocograph and next with Toconaute and next with the electrophysiological device Receives: Device: cardiotocograph; Device: Toconaute; Device: electrophysiological device (Micromed) |
| Cardiotocograph and electrophysiological device | Experimental | monitoring with the cardiotocograph and next with the electrophysiological device (Micromed) Receives: Device: cardiotocograph; Device: electrophysiological device (Micromed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start11 Dec 2018
- Primary completion30 Jul 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444909
- Sponsor's protocol ID
- 2017-A03123-50
- Acronym
- CIPTEx
- Status last verified
- Nov 2021
- First submitted
- 4 Jan 2018
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIPTEx : Collection of Information by Tocography External
- ClinicalTrials.gov ID
- NCT03444909
- Acronym / sponsor ID
- CIPTEx / 2017-A03123-50
- Conditions
- Pregnancy Related
- Keywords
- Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| cardiotocograph and Toconaute | Experimental | Device: cardiotocograph, Device: Toconautemonitoring with cardiotocograph and next with the Toconaute of Bioserenity |
| Cardiotocograph and Toconaute and Electrophysiological device | Experimental | Device: cardiotocograph, Device: Toconaute, Device: electrophysiological device (Micromed)monitoring withardiotocograph and next with Toconaute and next with the electrophysiological device |
| Cardiotocograph and electrophysiological device | Experimental | Device: cardiotocograph, Device: electrophysiological device (Micromed)monitoring with the cardiotocograph and next with the electrophysiological device (Micromed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Multiple pregnancy
- Women requiring a continuous monitoring (in advanced labour)
- Refusal of consent
- Minors
- Wounds on the stomach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiotocographMonitoring of 20 min with the cardiotocograph | Device | Cardiotocograph and Toconaute and Electrophysiological device, Cardiotocograph and electrophysiological device, cardiotocograph and Toconaute |
| ToconauteMonitoring of 20 min withToconaute | Device | Cardiotocograph and Toconaute and Electrophysiological device, cardiotocograph and Toconaute |
| electrophysiological device (Micromed)Monitoring of 20 min with the cardiotocograph | Device | Cardiotocograph and Toconaute and Electrophysiological device, Cardiotocograph and electrophysiological device |
Primary outcome
comparison of measures from Toconaute, cardiotocograph and Micromed device
Time frame: 1 year
evaluation of the quality of signal (heart rate of mother and foetus, electrocardiogramme mother and foetus, contractions)
1 secondary outcome
creation of a comparative database between the cardiotocograph and the toconaute and the electrophysiological device (micromed)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiotocograph, Toconaute and electrophysiological device (Micromed) in people with Pregnancy Related, run by BioSerenity at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of measures from Toconaute, cardiotocograph and Micromed device (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.