NCT02373800

Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).

Detailed description

The secondary objectives of this study are: A. To determine composite criteria (combining elastographic, parity and Bishop score information) that predict delivery mode. B. To determine the prognostic value of elastography as concerns delivery within 24 hours among patients induced via oxytocin with an intravaginal device releasing PGE2 (Bishop score \< 6). C. To determine the prognostic value of elastography as concerns delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering))among patients induced via oxytocin alone. D. To evaluate the intra- and inter-operator reproducibility of the cervical hardness score determined via elastography. E. To evaluate the economic impact of using the cervical hardness score from the point of view of the French social system (French health insurance) and the hospital.

Conditions

• Labor, Induced

Interventions

Type	Name	Description
DEVICE	Cervical ultrasound with elastography	Following routine vaginal exam with determination of Bishop's score, cervical ultrasound with elastography will be used to determine a cervical hardness score varying from 1 to 10. Patients are then hospitalized and labor induced 12 to 48 hours after the elastography.

Timeline

• Start date: 2016-02-04
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2015-02-27
• Last updated: 2019-01-11

Locations

1 site across 1 country: France