Evaluation of Transperineal Ultrasound Technic for Diagnostic Shorted Cervical Length for Pregnant Women (2nd and 3rd Trimester) Compared to Endovaginal Technic (Gold Standard)

Study Overview
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Brief Summary
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Endovaginal ultrasound is currently the gold standard to diagnose a shorted cervical length and, by extension, assess the risk of preterm labor. The major inconvenient is that this is an invasive method of diagnosis that tends to be poorly accepted by some patients. This study aims to evaluate the accuracy of a noninvasive transperineal ultrasound cervical measurement in comparison to the endovaginal technic in 2nd and 3nd trimester pregnant women where a cervical ultrasound is indicated.

Detailed Description
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The cervical length is a crucial part of the diagnostic of premature labor. The gold standard technic is the endovaginal ultrasound. This is a technic with good reproducibility and good precision. Some authors have found the transperineal technic to present the same characteristics, without being as invasive. The aim of the study was to compare the results of the less invasive technic to the current invasive gold standard in pregnant women who consult for contraction, or for whom cervical modification is suspected in order to determine whether the former could replace the latter.

Official Title
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Evaluation of Transperineal Ultrasound Technic for Diagnostic Shorted Cervical Length for Pregnant Women (2nd and 3rd Trimester) Compared to Endovaginal Technic (Gold Standard)

Conditions
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Ultrasound, Transperineal

Intervention / Treatment
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* Other: cervical ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between 2nd and 3rd trimester consulting in obstetric emergency for whom a cervical ultrasound is indicated Exclusion Criteria: minor patients mentally deficient persons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transperineal sonographic cervix assessment<br> | Other: cervical ultrasound<br>* All volunteer patients for whom a cervical ultrasound is indicated will have with a first operator the performing the usual technic, and with a second operator performing the trans perineal technic without being aware of the first measurement.<br>|
| Active Comparator: endovaginal sonographic cervix assessment<br> | Other: cervical ultrasound<br>* All volunteer patients for whom a cervical ultrasound is indicated will have with a first operator the performing the usual technic, and with a second operator performing the trans perineal technic without being aware of the first measurement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of measurement of the uterine cervix | difference of measurement of the uterine cervix will be done by analysing the variation between the transperineal measurement and endovaginal evaluation of the uterine cervix. Length will be measured in millimetres | at day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovaginal, ultrasound, transperineal