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

February 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: transperineal sonographic cervix assessment
Other: cervical ultrasound
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.
ACTIVE_COMPARATOR: endovaginal sonographic cervix assessment
Other: cervical ultrasound
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of measurement of the uterine cervix
Time Frame: 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
at day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2021

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (ACTUAL)

April 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2018_843_0037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ultrasound

Clinical Trials on cervical ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe