NCT04341597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

March 6, 2020

Last Update Submit

September 16, 2025

Conditions

UltrasoundTransperineal

Keywords

endovaginalultrasoundtransperineal

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

transperineal sonographic cervix assessment

EXPERIMENTAL
Other: cervical ultrasound

endovaginal sonographic cervix assessment

ACTIVE COMPARATOR
Other: cervical ultrasound

Interventions

cervical ultrasoundOTHER

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.

endovaginal sonographic cervix assessmenttransperineal sonographic cervix assessment

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women between 2nd and 3rd trimester consulting in obstetric emergency for whom a cervical ultrasound is indicated

You may not qualify if:

  • minor patients
  • mentally deficient persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Related Publications (1)

  • Krief D, Foulon A, Tondreau A, Diouf M, Sergent F, Gondry J, Chevreau J. Transperineal ultrasound in routine uterine cervix measurement. Arch Gynecol Obstet. 2023 Feb;307(2):387-393. doi: 10.1007/s00404-022-06521-4. Epub 2022 Mar 23.

    PMID: 35318500RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

April 10, 2020

Study Start

March 6, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2021

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)