NCT02021539

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstetric Labor
• Labor Onset
• Obstetric Labor, Premature

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-12-27
• Last updated: 2017-06-19

Locations

1 site across 1 country: France