Delivery UterineECOLDIANCT02570620
Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time
A study testing Ultrasonography of the cervix in people with Delivery Uterine and Birth; Induced, run by University Hospital, Tours at 3 sites in France.
Trial summary
Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Delivery Uterine, Birth; Induced
- What is being tested?
- Ultrasonography of the cervix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2010to Mar 2014
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 years
- Single pregnancy to term (> 37 weeks) in cephalic presentation
- Bishop score on the day of inclusion equal to 4.5 or 6
- Medical indication in accordance with professional recommendations of the April 2008 HAS.
Who cannot join
- Cicatricial uterus
- Placenta previa
- Parity > 3 (more than 3 previous deliveries > 22 weeks)
- History of cone biopsy and strapping
- Known fetal malformation
- Known allergy to prostaglandins
- Woman under guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital of Nantes
Nantes
Hospital of Orleans
Orléans
University Hospital of Tours
Tours
About this study
Official title: Apport de l'échographie du Col Dans l'évaluation du Délai Induction Accouchement (DIA) Chez Des Patientes à Score de Bishop défavorable après déclenchement Par Dinoprostone Intravaginal
Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.
- Conditions
- Delivery Uterine, Birth; Induced
- Being tested
- Ultrasonography of the cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of the cervixDevice
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort of patients | Experimental | Patients will benefit from an ultrasonography of the cervix through endovaginal before induction of prostaglandins Receives: Device: Ultrasonography of the cervix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in hours between induction of prostaglandins and delivery
Delivery whether a vaginal delivery or cesarean
Measured: On the day of inclusion after induction of prostaglandins. In relation to the time of delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startSep 2010
- Primary completionMar 2014
- Study completionMar 2014
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 Delivery UterineStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme POTIN, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570620
- Sponsor's protocol ID
- PHRI09-JP/ECOLDIA
- Acronym
- ECOLDIA
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2015
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Arthuis C, Potin J, Winer N, Tavernier E, Paternotte J, Ramos A, Perrotin F, Diguisto C. Contribution of ultrasonography to the prediction of the induction-delivery interval: The ECOLDIA prospective multicenter cohort study. J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102196. doi: 10.1016/j.jogoh.2021.102196. Epub 2021 Jul 10.
PubMed 34256166
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apport de l'échographie du Col Dans l'évaluation du Délai Induction Accouchement (DIA) Chez Des Patientes à Score de Bishop défavorable après déclenchement Par Dinoprostone Intravaginal
- ClinicalTrials.gov ID
- NCT02570620
- Acronym / sponsor ID
- ECOLDIA / PHRI09-JP/ECOLDIA
- Conditions
- Delivery Uterine, Birth; Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Oct 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.
Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort of patients | Experimental | Device: Ultrasonography of the cervixPatients will benefit from an ultrasonography of the cervix through endovaginal before induction of prostaglandins |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Single pregnancy to term (> 37 weeks) in cephalic presentation
- Bishop score on the day of inclusion equal to 4.5 or 6
- Medical indication in accordance with professional recommendations of the April 2008 HAS.
Key exclusion criteria (7 listed)
- Cicatricial uterus
- Placenta previa
- Parity > 3 (more than 3 previous deliveries > 22 weeks)
- History of cone biopsy and strapping
- Known fetal malformation
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 |
|---|---|---|
| Ultrasonography of the cervix | Device | Observational cohort of patients |
Primary outcome
Time in hours between induction of prostaglandins and delivery
Time frame: On the day of inclusion after induction of prostaglandins. In relation to the time of delivery.
Delivery whether a vaginal delivery or cesarean
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 30 Dec 2025.
- Results publication: PubMed 34256166Arthuis C, Potin J, Winer N, Tavernier E, Paternotte J, Ramos A, Perrotin F, Diguisto C. Contribution of ultrasonography to the prediction of the induction-delivery interval: The ECOLDIA prospective multicenter cohort study. J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102196. doi: 10.1016/j.jogoh.2021.102196. Epub 2021 Jul 10.
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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.
Jérôme POTIN principal investigator
University Hospital, Tours
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography of the cervix in people with Delivery Uterine and Birth; Induced, run by University Hospital, Tours at 3 sites 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 7 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Time in hours between induction of prostaglandins and delivery (time frame: On the day of inclusion after induction of prostaglandins. In relation to the time of delivery.). 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 NCT02570620, 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 30 Dec 2025.