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

Not Applicable

Completed

• Conditions: Transperineal; Ultrasound

• Registration Number: NCT04341597
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-10
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
difference of measurement of the uterine cervix	at day 0	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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France