NCT02570620

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

October 2, 2015

Last Update Submit

December 23, 2025

Conditions

Delivery UterineBirth; Induced

Outcome Measures

Primary Outcomes (1)

  • Time in hours between induction of prostaglandins and delivery

    Delivery whether a vaginal delivery or cesarean

    On the day of inclusion after induction of prostaglandins. In relation to the time of delivery.

Study Arms (1)

Observational cohort of patients

EXPERIMENTAL

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

Device: Ultrasonography of the cervix

Interventions

Ultrasonography of the cervixDEVICE
Observational cohort of patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 years
  • Single pregnancy to term (\> 37 weeks) in cephalic presentation
  • Medical indication in accordance with professional recommendations of the April 2008 HAS.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of Nantes

Nantes, France

Location

Hospital of Orleans

Orléans, France

Location

University Hospital of Tours

Tours, France

Location

Related Publications (1)

  • 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.

    PMID: 34256166RESULT

Study Officials

  • Jérôme POTIN

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 7, 2015

Study Start

September 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

FR(3)