The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery (ElastoMAP)

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Obstetric Labor; Obstetric Labor, Premature; Labor Onset

Treatments: Biological: Vaginal fibronectin measurement; Procedure: Cervical ultrasound +elastography 2; Drug: Tocolytic treatment for 2 hours; Procedure: Cervical ultrasound +elastography 1

Study type: Observational

Funder types: Other

Identifiers

NCT02021539

LOCAL/2013/VL-01

Details and patient eligibility

About

The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

Full description

The secondary objectives of this study are:

A-To compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours.

B-To evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the French social security system and the hospital.

C-To evaluate the prognostic value of elastographic measurements in the subgroup twins.

D-To study elastography variation according to patient outcomes.

E-Evaluate the reproducibility of intra-and inter-rater elastographic measurements.

Enrollment: 66 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 women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm)
• Single or multiple pregnancy

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
• The patient has lost her water (placental rupture)
• History of cervical surgery

Trial design

66 participants in 1 patient group

The study population

Description:

The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included). Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2

Treatment:

Drug: Tocolytic treatment for 2 hours

Biological: Vaginal fibronectin measurement

Procedure: Cervical ultrasound +elastography 2

Procedure: Cervical ultrasound +elastography 1