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Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy

NCT04350632 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-14

No results posted yet for this study

Summary

The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. The main endpoint of this study is to assess the intra-observer and the inter-observer reproducibility of a the external anal sphincter assessment using shear wave elastography in term pregnant women.

Conditions

  • Obstetric Anal Sphincter Injury

Interventions

DIAGNOSTIC_TEST

Shear wave elastography assessment of the external anal sphincter

Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology * Women in lithotomy position with an empty bladder * The linear probe is applied on transversal plane on the perineal with a transperineal approach * The external anal sphincter will be identified in 2D ultrasound using a SL 18-5 linear probe * Viscoelastic properties of the muscle will be assessed by measuring the shear modulus at rest, Valsalva maneuver and contraction * Exactly the same investigations will be performed for the two visits planned in the protocol. In the first visit, it will be one single observer and for the second it will be 2 observers. * Data about the mode of delivery and the occurrence of OASI will be collected into women's medical fil

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2021-10-07
Completion
2021-10-14

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 NCT04350632 on ClinicalTrials.gov