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

NCT04350632 | Unknown

• 1 other identifier: 2020-A00762-37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• value of shear modulus measures in the external anal sphincter for each visit with the calculation of the ICC

  The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient

  up to seven days

• value of shear modulus measures in the external anal sphincter for each visit with the calculation of the coefficent of variation

  The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Variation Coefficient

  up to seven days

Secondary Outcomes (3)

• Perineal tears at childbirth

  up to 4 weeks

• Feasibility of the assessment of the external anal sphincter: percentage of completed procedure

  up to seven days

• Acceptability of the procedure: question with a scale

  up to seven days

Interventions

Shear wave elastography assessment of the external anal sphincter DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: obsterics
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women aged of 18 years or more
• weeks or more of pregnancy
• without any previous delivery (vaginal or cesarean delivery)
• body mass index \< 35Kg.m-2
• without history of Crohn's disease
• without history of peri anal surgery
• without any proctologic disease
• without any muscular chronic disease
• having a normal pregnancy
• without any untreated psychiatric disorders
• without any judicial protection
• affiliated to a health insurance

You may not qualify if:

• pregnant women younger than 18 years old
• obstetric term inferior than 37 weeks
• history of vaginal and/or cesarean delivery
• body mass index of 35Kg.m-2 or more
• history of Crohn's disease
• history of peri anal surgery
• proctologic disease
• muscular chronic disease
• pathological pregnancy (intrauterine growth restriction, pre eclampsia etc..)
• untreated psychiatric disorders
• women under judicial protection
• women without affiliated to a health insurance

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

Central Study Contacts

Bertrand GACHON, MD, PhD student

CONTACT

+33 5 49 44 39 45; bertrand.gachon@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 17, 2020
• Study Start: July 7, 2020
• Primary Completion: October 7, 2021
• Study Completion: October 14, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

FR (1)