Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT04350632
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
Sponsor:
Poitiers University Hospital
Organization:
Study Overview
Official Title:
Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEA ELASTO 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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: