Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time (ECOLDIA)

October 5, 2015 updated by: University Hospital, Tours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • University Hospital of Nantes
      • Orleans, France
        • Hospital of Orleans
      • Tours, France
        • University Hospital of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Observational cohort of patients
Patients will benefit from an ultrasonography of the cervix through endovaginal before induction of prostaglandins
Device: Ultrasonography of the cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On the day of inclusion after induction of prostaglandins. In relation to the time of delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Jérôme POTIN, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PHRI09-JP/ECOLDIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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