Labor, InducedElastoDéclenchNCT02373800
Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation
An observational study of Labor, Induced, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Cervical ultrasound with elastography
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2016to Sep 2018
- 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 is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center.
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 woman with a medical indication for pre-term labor induction: 37 to 42 weeks of gestation.
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
- History of cervical surgery
- Malformation of the cervix
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).
Read the detailed description
The secondary objectives of this study are:
- To determine composite criteria (combining elastographic, parity and Bishop score information) that predict delivery mode.
- To determine the prognostic value of elastography as concerns delivery within 24 hours among patients induced via oxytocin with an intravaginal device releasing PGE2 (Bishop score < 6).
- To determine the prognostic value of elastography as concerns delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering))among patients induced via oxytocin alone.
- To evaluate the intra- and inter-operator reproducibility of the cervical hardness score determined via elastography.
- To evaluate the economic impact of using the cervical hardness score from the point of view of the French social system (French health insurance) and the hospital.
- Conditions
- Labor, Induced
- Being tested
- Cervical ultrasound with elastography
- Keywords
- Induced, pre-term labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ultrasound with elastographyDevice
Following routine vaginal exam with determination of Bishop's score, cervical ultrasound with elastography will be used to determine a cervical hardness score varying from 1 to 10. Patients are then hospitalized and labor induced 12 to 48 hours after the elastography.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center.
Intervention: Cervical ultrasound with elastography Receives: Device: Cervical ultrasound with elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical hardness score
A score varying from 0 to 10 determined during cervical ultrasound with elastography.
Measured: Day 0 (baseline)
Mode of delivery: vaginal delivery versus cesarean
Measured: Day 2
Secondary outcomes (7)
Bishop score
Measured: Day 0 (baseline)
Parity
Measured: Day 0 (baseline)
Time lapsed between labor induction and delivery
Measured: Day 2
Induction mode
oxytocin alone or with an intravaginal device releasing PGE2
Measured: Day 0 (baseline)
Cervical hardness score for reproductibility 1
Second reading (by the same, original operator) of ultrasound+elastography recording
Measured: Day 0 (baseline)
Cervical hardness score for reproductibility 2
Third reading (by a second operator) of ultrasound+elastography recording
Measured: Day 0 (baseline)
Cost of hospital stay
Measured: Expected average of 4-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start4 Feb 2016
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: insufficient inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 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, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373800
- Sponsor's protocol ID
- LOCAL/2013/VL-02
- Other IDs
- 2014-A00828-39
- Acronym
- ElastoDéclench
- Status last verified
- Jan 2019
- First submitted
- 23 Feb 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT02373800
- Acronym / sponsor ID
- ElastoDéclench / LOCAL/2013/VL-02
- Conditions
- Labor, Induced
- Keywords
- Induced, pre-term labor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient inclusions
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Feb 2015 (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 primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).
Detailed description
The secondary objectives of this study are:
- To determine composite criteria (combining elastographic, parity and Bishop score information) that predict delivery mode.
- To determine the prognostic value of elastography as concerns delivery within 24 hours among patients induced via oxytocin with an intravaginal device releasing PGE2 (Bishop score < 6).
- To determine the prognostic value of elastography as concerns delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering))among patients induced via oxytocin alone.
- To evaluate the intra- and inter-operator reproducibility of the cervical hardness score determined via elastography.
- To evaluate the economic impact of using the cervical hardness score from the point of view of the French social system (French health insurance) and the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Device: Cervical ultrasound with elastographyThe study population is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center. Intervention: Cervical ultrasound with elastography |
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 is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center.
Key inclusion criteria (3 listed)
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Pregnant woman with a medical indication for pre-term labor induction: 37 to 42 weeks of gestation.
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
- History of cervical surgery
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 with elastographyFollowing routine vaginal exam with determination of Bishop's score, cervical ultrasound with elastography will be used to determine a cervical hardness score varying from 1 to 10. Patients are then hospitalized and labor induced 12 to 48 hours after the elastography. | Device | The study population |
Primary outcome
Cervical hardness score
Time frame: Day 0 (baseline)
A score varying from 0 to 10 determined during cervical ultrasound with elastography.
Mode of delivery: vaginal delivery versus cesarean
Time frame: Day 2
7 secondary outcomes
Bishop score
Time frame: Day 0 (baseline)
Parity
Time frame: Day 0 (baseline)
Time lapsed between labor induction and delivery
Time frame: Day 2
Induction mode
Time frame: Day 0 (baseline)
Cervical hardness score for reproductibility 1
Time frame: Day 0 (baseline)
Cervical hardness score for reproductibility 2
Time frame: Day 0 (baseline)
Cost of hospital stay
Time frame: Expected average of 4-5 days
Results and safety
The study was stopped early (reason given: insufficient inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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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 principal investigator
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 Labor, Induced, 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 3 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 11 Jan 2019. 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: insufficient inclusions). 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?
Cervical hardness score (time frame: Day 0 (baseline)). The study lists 2 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 11 Jan 2019.