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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Terminated

CT.gov ID

NCT02021539

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obstetric Labor Labor Onset Obstetric Labor, Premature	Procedure: Cervical ultrasound +elastography 1 Biological: Vaginal fibronectin measurement Drug: Tocolytic treatment for 2 hours Procedure: Cervical ultrasound +elastography 2

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 Design

Study Type:

Observational

Actual Enrollment :

66 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
The study population 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	Procedure: Cervical ultrasound +elastography 1 Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. Biological: Vaginal fibronectin measurement Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. Drug: Tocolytic treatment for 2 hours Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed. Procedure: Cervical ultrasound +elastography 2 Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.

Arm

Intervention/Treatment

The study population

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

Procedure: Cervical ultrasound +elastography 1

Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.

Biological: Vaginal fibronectin measurement

Drug: Tocolytic treatment for 2 hours

Procedure: Cervical ultrasound +elastography 2

Outcome Measures

Primary Outcome Measures

Ultrasound measure of the cervix (mm) [Day 0]
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

Elastography score [after 2 hours of tocolytic treatment on day 0]
Score ranges from 0 to 10
Vaginal fetal fibronectin [Day 0]
Vaginal fetal fibronectin [Day 2]
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]

Other Outcome Measures

Patient age [baseline (day 0)]
Body mass index [baseline (day 0)]
Number of previous vaginal deliveries [baseline (day 0)]
Pregnancy term [baseline (day 0)]
Prescribed treatment (rest, hospitalization, medications) [baseline (day 0)]
Delay between first cervical ultrasound upon patient arrival and first ultrasound with elastography [Day 0 or 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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