Premature BirthNCT01032564
Interest of HI-RTE Elasticity in Obstetric
A study testing The elastography (elasticity imagery) in people with Premature Birth, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay. If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- The elastography (elasticity imagery)
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Jul 2013
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unique(only) or multiple pregnancy about is the term presenting an intra Utérine pregnancy in the 1st quarter ·
- Signed lit(enlightened) consent ·
- Patient of more than 18 years old
Who cannot join
- Suspicion of pregnancy extra utérine, hémodynamique unstable, important métrorragies, maternal diabetes, arterial high blood pressure
- impossibility to receive the consent lit(enlightened) by the patient · patient old under age 18
Trial locations and contacts
1 site in 1 country.
About this study
In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.
If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.
Read more
The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.
Its contribution in obstetric must be estimated to improve patients minimum fare.
The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women
- Conditions
- Premature Birth
- Being tested
- The elastography (elasticity imagery)
- Keywords
- estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The elastography (elasticity imagery)Other
This diagnosis mean use the ultrasonography to measure the tissues answer under pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
The elastography (elasticity imagery)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRETELLE, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032564
- Sponsor's protocol ID
- 2009-A00814-53
- Other IDs
- 2009-22
- Status last verified
- Aug 2014
- First submitted
- 11 Dec 2009
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sabiani L, Haumonte JB, Loundou A, Caro AS, Brunet J, Cocallemen JF, D'ercole C, Bretelle F. Cervical HI-RTE elastography and pregnancy outcome: a prospective study. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:80-4. doi: 10.1016/j.ejogrb.2015.01.016. Epub 2015 Jan 23.
PubMed 25666343
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of HI-RTE Elasticity in Obstetric
- ClinicalTrials.gov ID
- NCT01032564
- Acronym / sponsor ID
- 2009-A00814-53
- Conditions
- Premature Birth
- Keywords
- estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Dec 2009 (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.
In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.
If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.
The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.
Its contribution in obstetric must be estimated to improve patients minimum fare.
The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unique(only) or multiple pregnancy about is the term presenting an intra Utérine pregnancy in the 1st quarter ·
- Signed lit(enlightened) consent ·
- Patient of more than 18 years old
Key exclusion criteria (2 listed)
- Suspicion of pregnancy extra utérine, hémodynamique unstable, important métrorragies, maternal diabetes, arterial high blood pressure
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 |
|---|---|---|
| The elastography (elasticity imagery)This diagnosis mean use the ultrasonography to measure the tissues answer under pressure | Other | – |
Primary outcome
The elastography (elasticity imagery)
Time frame: 18 months
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 29 Aug 2014.
- Derived from this study: PubMed 25666343Sabiani L, Haumonte JB, Loundou A, Caro AS, Brunet J, Cocallemen JF, D'ercole C, Bretelle F. Cervical HI-RTE elastography and pregnancy outcome: a prospective study. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:80-4. doi: 10.1016/j.ejogrb.2015.01.016. Epub 2015 Jan 23.
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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.
Florence BRETELLE principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The elastography (elasticity imagery) in people with Premature Birth, run by Assistance Publique Hopitaux De Marseille 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 3 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: finished, as of the sponsor's last update on 29 Aug 2014. 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?
The elastography (elasticity imagery) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032564, which also lists 1 linked publication.
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 29 Aug 2014.