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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Labor, Induced

Treatments: Device: Cervical ultrasound with elastography

Study type: Observational

Funder types: Other

Identifiers

NCT02373800

LOCAL/2013/VL-02

2014-A00828-39 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 95 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• Pregnant woman with a medical indication for pre-term labor induction: 37 to 42 weeks of gestation.

Exclusion criteria

• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• History of cervical surgery
• Malformation of the cervix

Trial design

95 participants in 1 patient group

The study population

Description:

The study population is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center. Intervention: Cervical ultrasound with elastography

Treatment:

Device: Cervical ultrasound with elastography