The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
NCT02021539 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 66
Last updated 2017-06-19
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).
Conditions
- Obstetric Labor
- Labor Onset
- Obstetric Labor, Premature
Interventions
- 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.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Nīmes
lead OTHER
Principal Investigators
-
Vincent Letouzey, MD · Centre Hospitalier Universitaire de Nîmes
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- France
Study Locations
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