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

Obstetric Anal Sphincter Injury Clinical Trial

— SEA ELASTO 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04350632
• Other study ID #: 2020-A00762-37
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: October 14, 2021

Study information

• Verified date: April 2021
• Source: Poitiers University Hospital
• Contact: Bertrand GACHON, MD, PhD student
• Phone: +33 5 49 44 39 45
• Email: bertrand.gachon[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Investigations Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology using a transperineal approach in term pregnant women in two visits (the 1st one with only one observer and the second one with two observers)

Follow up Prospective study including nulliparous term pregnant women with 2 visits planned, spaced at least by 12 hours and, for the most, 7 days.

Primary outcome: 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 and Variation Coefficient.

Secondary outcomes: The secondary outcomes will be the percentage of completed procedure (ability to see the external sphincter and to obtain a measure of the shear modulus), the existence of a perineal tear according the RCOG-OMS classification and the answer to an acceptability question.

Study design: Prospective monocentric study including nulliparous term pregnant women with two visits spaced of at least 12 hours and, for the most, 7 days.

Interventions: 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 file

Number of subjects: 40 volunteers pregnant women are planned for this research

Statistical analysis: The number of successful procedures will be reported as effectives and percentages.

Reproducibility will be reported by calculating the coefficient of variation and the intraclass correlation coefficient. The level of significance will be considered for p<0.05

Conditions : Obstetric anal sphincter injury

Keywords: OASI; childbirth; perineal traumatism; delivery; biomechanics; shear wave elastography

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 14, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant women aged of 18 years or more

• 37 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obstetric Anal Sphincter Injury

Intervention

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

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Perineal tears at childbirth	the existence of a perineal tear according the RCOG-OMS classification	up to 4 weeks
Secondary	Feasibility of the assessment of the external anal sphincter: percentage of completed procedure	percentage of completed procedure (ability to identify the extarnal anal sphincter and to perform a shear wave elastography assessment)	up to seven days
Secondary	Acceptability of the procedure: question with a scale	answer to the acceptability question with a scale from 0 to ten	up to seven days