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

Terminated

• Conditions: Obstetric Labor; Labor Onset; Obstetric Labor, Premature
• Interventions: Procedure: Cervical ultrasound +elastography 1; Biological: Vaginal fibronectin measurement; Drug: Tocolytic treatment for 2 hours; Procedure: Cervical ultrasound +elastography 2

• Registration Number: NCT02021539
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Cervical ultrasound +elastography 1	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
The study population	Tocolytic treatment for 2 hours	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
The study population	Cervical ultrasound +elastography 2	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
The study population	Vaginal fibronectin measurement	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

Primary Outcome Measures

Name	Time	Method
Ultrasound measure of the cervix (mm)	Day 2
Elastography score	Day 0 or within 12 hours	The score ranges from 0 to 10.

Secondary Outcome Measures

Name	Time	Method
Elastography score	after 2 hours of tocolytic treatment on day 0	Score ranges from 0 to 10
Avoidable hospital costs	Hospital discharge (expected maximum of 20 days)
Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no	Day 0 or 1
Vaginal fetal fibronectin	Day 2

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France