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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02021539 on ClinicalTrials.gov