Obstetric LaborElastoMAPNCT02021539
The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
An observational study of Obstetric Labor and Labor Onset, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Labor, Labor Onset, Obstetric Labor, Premature
- What is being tested?
- Cervical ultrasound +elastography 1, Vaginal fibronectin measurement and Tocolytic treatment for 2 hours
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Who may be able to join
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm)
- Single or multiple pregnancy
Who cannot join
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient has lost her water (placental rupture)
- History of cervical surgery
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).
Read the detailed description
The secondary objectives of this study are:
A-To compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours.
B-To evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the French social security system and the hospital.
C-To evaluate the prognostic value of elastographic measurements in the subgroup twins.
D-To study elastography variation according to patient outcomes.
E-Evaluate the reproducibility of intra-and inter-rater elastographic measurements.
- Conditions
- Obstetric Labor, Labor Onset, Obstetric Labor, Premature
- Being tested
- Cervical ultrasound +elastography 1, Vaginal fibronectin measurement, Tocolytic treatment for 2 hours, Cervical ultrasound +elastography 2
- Keywords
- Elastography of the cervix, Cervical elastography, Predicting delivery
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ultrasound +elastography 1Procedure or surgery
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
Vaginal fibronectin measurementBiological
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
Tocolytic treatment for 2 hoursDrug
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
Cervical ultrasound +elastography 2Procedure or surgery
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2 Receives: Procedure: Cervical ultrasound +elastography 1; Biological: Vaginal fibronectin measurement; Drug: Tocolytic treatment for 2 hours; Procedure: Cervical ultrasound +elastography 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound measure of the cervix (mm)
Measured: Day 0
Ultrasound measure of the cervix (mm)
Measured: Day 2
Elastography score
The score ranges from 0 to 10.
Measured: Day 0 or within 12 hours
Secondary outcomes (5)
Elastography score
Score ranges from 0 to 10
Measured: after 2 hours of tocolytic treatment on day 0
Vaginal fetal fibronectin
Measured: Day 0
Vaginal fetal fibronectin
Measured: Day 2
Avoidable hospital costs
Measured: Hospital discharge (expected maximum of 20 days)
Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no
Measured: Day 0 or 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric LaborStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021539
- Sponsor's protocol ID
- LOCAL/2013/VL-01
- Acronym
- ElastoMAP
- Status last verified
- Jun 2017
- First submitted
- 20 Dec 2013
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
- ClinicalTrials.gov ID
- NCT02021539
- Acronym / sponsor ID
- ElastoMAP / LOCAL/2013/VL-01
- Conditions
- Obstetric Labor, Labor Onset, Obstetric Labor, Premature
- Keywords
- Elastography of the cervix, Cervical elastography, Predicting delivery
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Dec 2013 (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 hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).
Detailed description
The secondary objectives of this study are:
A-To compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours.
B-To evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the French social security system and the hospital.
C-To evaluate the prognostic value of elastographic measurements in the subgroup twins.
D-To study elastography variation according to patient outcomes.
E-Evaluate the reproducibility of intra-and inter-rater elastographic measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Procedure: Cervical ultrasound +elastography 1, Biological: Vaginal fibronectin measurement, Drug: Tocolytic treatment for 2 hours, Procedure: Cervical ultrasound +elastography 2The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included). Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Key inclusion criteria (4 listed)
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm)
- Single or multiple pregnancy
Key exclusion criteria (6 listed)
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient has lost her water (placental rupture)
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 |
|---|---|---|
| Cervical ultrasound +elastography 1Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. | Procedure or surgery | The study population |
| Vaginal fibronectin measurementIncluded patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. | Biological | The study population |
| Tocolytic treatment for 2 hoursIncluded patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. | Drug | The study population |
| Cervical ultrasound +elastography 2Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. | Procedure or surgery | The study population |
Primary outcome
Ultrasound measure of the cervix (mm)
Time frame: Day 0
Ultrasound measure of the cervix (mm)
Time frame: Day 2
Elastography score
Time frame: Day 0 or within 12 hours
The score ranges from 0 to 10.
5 secondary outcomes
Elastography score
Time frame: after 2 hours of tocolytic treatment on day 0
Vaginal fetal fibronectin
Time frame: Day 0
Vaginal fetal fibronectin
Time frame: Day 2
Avoidable hospital costs
Time frame: Hospital discharge (expected maximum of 20 days)
Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no
Time frame: Day 0 or 1
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
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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.
Vincent Letouzey, MD study director
Centre Hospitalier Universitaire de Nīmes
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 Obstetric Labor and Labor Onset, run by Centre Hospitalier Universitaire de Nīmes 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 6 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 19 Jun 2017. 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. 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?
Ultrasound measure of the cervix (mm) (time frame: Day 0). The study lists 3 primary outcomes in all. 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 19 Jun 2017.