Uterine ContractionPropEHGNCT02814344
Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
An observational study of Uterine Contraction and Pregnancy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. 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
- Uterine Contraction, Pregnancy, Delivery, Obstetric
- What is being tested?
- Electrohysterography
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2011to 10 Oct 2017
- Phase
- Observational
- 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
Study population: pregnant women
Who may be able to join
- singleton pregnancy
Who cannot join
- Minor patient
- twin pregnancy or more
Trial locations and contacts
1 site in 1 country.
About this study
The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.
- Conditions
- Uterine Contraction, Pregnancy, Delivery, Obstetric
- Being tested
- Electrohysterography
- Keywords
- labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrohysterographyDevice
| Study group | Role | What they receive |
|---|---|---|
| pregnant women not in labour | from 24 weeks of gestation until term, provided that they are not in labour
Electrohysterography Receives: Device: Electrohysterography | |
| women in labour | Electrohysterography Receives: Device: Electrohysterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
parameter H2
To demonstrate a difference of propagation of the electrical signal during a physiological contraction of pregnancy and uterine contraction during delivery. The parameter H2 (nonlinear correlation coefficient) will be used to measure propagation of the electrical signal.
Measured: H2 value measured at each contraction during 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start9 Aug 2011
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Why it stopped: Investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ContractionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean GONDRY, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814344
- Sponsor's protocol ID
- PI10-PR-GONDRY
- Acronym
- PropEHG
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2016
- Last updated
- 15 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
- ClinicalTrials.gov ID
- NCT02814344
- Acronym / sponsor ID
- PropEHG / PI10-PR-GONDRY
- Conditions
- Uterine Contraction, Pregnancy, Delivery, Obstetric
- Keywords
- labour
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator choice
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Aug 2011 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- 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 original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women not in labour | – | Device: Electrohysterographyfrom 24 weeks of gestation until term, provided that they are not in labour Electrohysterography |
| women in labour | – | Device: ElectrohysterographyElectrohysterography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (1 listed)
- singleton pregnancy
Key exclusion criteria (2 listed)
- Minor patient
- twin pregnancy or more
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 |
|---|---|---|
| Electrohysterography | Device | pregnant women not in labour, women in labour |
Primary outcome
parameter H2
Time frame: H2 value measured at each contraction during 1 hour
To demonstrate a difference of propagation of the electrical signal during a physiological contraction of pregnancy and uterine contraction during delivery. The parameter H2 (nonlinear correlation coefficient) will be used to measure propagation of the electrical signal.
Results and safety
The study was stopped early (reason given: Investigator choice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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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.
Jean GONDRY, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Contraction and Pregnancy, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Jul 2020. 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 was stopped early (reason given: Investigator choice). Results are not available in the source record.
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?
parameter H2 (time frame: H2 value measured at each contraction during 1 hour). 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 15 Jul 2020.