Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time

NCT ID: NCT02570620

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Delivery Uterine Birth; Induced

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Observational cohort of patients

Patients will benefit from an ultrasonography of the cervix through endovaginal before induction of prostaglandins

Group Type EXPERIMENTAL

Ultrasonography of the cervix

Intervention Type DEVICE

Interventions

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Ultrasonography of the cervix

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme POTIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University Hospital of Nantes

Nantes, , France

Site Status

Hospital of Orleans

Orléans, , France

Site Status

University Hospital of Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34256166 (View on PubMed)

Other Identifiers

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PHRI09-JP/ECOLDIA

Identifier Type: -

Identifier Source: org_study_id