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

Delivery Uterine Clinical Trial

— ECOLDIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570620
• Other study ID #: PHRI09-JP/ECOLDIA
• Status: Completed
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 5, 2015
• Start date: September 2010
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth; Induced
• Delivery Uterine

Intervention

Device:
• Ultrasonography of the cervix

Locations

Country	Name	City	State
France	University Hospital of Nantes	Nantes
France	Hospital of Orleans	Orleans
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No